122 results on '"Scheepers HCJ"'
Search Results
2. An economic analysis of immediate delivery and expectant monitoring in women with hypertensive disorders of pregnancy, between 34 and 37 weeks of gestation (HYPITAT‐II)
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van Baaren, G‐J, Broekhuijsen, K, van Pampus, MG, Ganzevoort, W, Sikkema, JM, Woiski, MD, Oudijk, MA, Bloemenkamp, KWM, Scheepers, HCJ, Bremer, HA, Rijnders, RJP, van Loon, AJ, Perquin, DAM, Sporken, JMJ, Papatsonis, DNM, van Huizen, ME, Vredevoogd, CB, Brons, JTJ, Kaplan, M, van Kaam, AH, Groen, H, Porath, M, van den Berg, PP, Mol, BWJ, Franssen, MTM, and Langenveld, J
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- 2017
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3. Rapid target allopurinol concentrations in the hypoxic fetus after maternal administration during labour
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Kaandorp, J J, van den Broek, M P H, Benders, M J N L, Oudijk, M A, Porath, M M, Bambang Oetomo, S, Wouters, M G A J, van Elburg, Ruurd, Franssen, M T M, Bos, A F, Mol, B W J, Visser, G H A, van Bel, F, Rademaker, C M A, Derks, J B, de Haan, TR, Boon, J, de Boer, IP, Rijnders, RJP, Jacobs, CJWFM, Scheepers, HCJ, Gavilanes, AW, Bloemenkamp, KWM, Rijken, M, van Meir, CA, von Lindern, JS, Huisjes, AJM, and Bakker, CMJER
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- 2014
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4. Temporizing management vs immediate delivery in early-onset severe preeclampsia between 28 and 34 weeks of gestation (TOTEM study): An open-label randomized controlled trial
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Duvekot, J.J., Duijnhoven, RG, van Horen, E, Bax, CJ, Bloemenkamp, KW, Brussé, Ingrid, Dijk, PH, Franssen, MT, Franx, A (Arie), Oudijk, MA, Porath, MM, Scheepers, HCJ, van Wassenaer-Leemhuis, AG, van Drongelen, J, Mol, BW, Ganzevoort, W, Duvekot, J.J., Duijnhoven, RG, van Horen, E, Bax, CJ, Bloemenkamp, KW, Brussé, Ingrid, Dijk, PH, Franssen, MT, Franx, A (Arie), Oudijk, MA, Porath, MM, Scheepers, HCJ, van Wassenaer-Leemhuis, AG, van Drongelen, J, Mol, BW, and Ganzevoort, W
- Abstract
Introduction: There is little evidence to guide the timing of delivery of women with early-onset severe preeclampsia. We hypothesize that immediate delivery is not inferior for neonatal outcome but reduces maternal complications compared with temporizing management. Material and methods: This Dutch multicenter open-label randomized clinical trial investigated non-inferiority for neonatal outcome of temporizing management as compared with immediate delivery (TOTEM NTR 2986) in women between 27+5 and 33+5 weeks of gestation admitted for early-onset severe preeclampsia with or without HELLP syndrome. In participants allocated to receive immediate delivery, either induction of labor or cesarean section was initiated at least 48 hours after admission. Primary outcomes were adverse perinatal outcome, defined as a composite of severe respiratory distress syndrome, bronchopulmonary dysplasia, culture proven sepsis, intraventricular hemorrhage grade 3 or worse, periventricular leukomalacia grade 2 or worse, necrotizing enterocolitis stage 2 or worse, and perinatal death. Major maternal complications were secondary outcomes. It was estimated 1130 women needed to be enrolled. Analysis was by intention-to-treat. Results: The trial was halted after 35 months because of slow recruitment. Between February 2011 and December 2013, a total of 56 women were randomized to immediate delivery (n = 26) or temporizing management (n = 30). Median gestational age at randomization was 30 weeks. Median prolongation of pregnancy was 2 days (interquartile range 1-3 days) in the temporizing management group. Mean birthweight was 1435 g after immediate delivery vs 1294 g after temporizing management (P =.14). The adverse perinatal outcome rate was 55% in the immediate delivery group vs 52% in the temporizing management group (relative risk 1.06; 95% confidence interval 0.67-1.70). In both groups there was one neonatal death and no maternal deaths. In the temporizing treatm
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- 2021
5. Cost-effectiveness of Diagnostic Testing Strategies Including Cervical-Length Measurement and Fibronectin Testing in Women With Symptoms of Preterm Labor EDITORIAL COMMENT
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van Baaren, GJ, Vis, JY, Wilms, FF, Oudijk, MA, Kwee, A, Porath, MM, Scheepers, HCJ, Spaanderman, MEA, Bloemenkamp, KWM, Haak, MC, Bax, CJ, Cornette, J.M.J., Duvekot, J.J., Bijvanck, B, Eyck, J, Franssen, MTM, Sollie, KM, Vandenbussche, F, Woiski, M, Bolte, AC, van der Post, JAM, Bossuyt, PMM, Opmeer, BC, Mol, BWJ (Ben), Reproductive Origins of Adult Health and Disease (ROAHD), and Obstetrics & Gynecology
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- 2018
6. Clinical characteristics of women captured by extending the definition of severe postpartum haemorrhage with 'refractoriness to treatment': a cohort study
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Henriquez, D, Gillissen, A, Smith, SM, Cramer, RA, van den Akker, T, Zwart, JJ, van Roosmalen, JJ, Bloemenkamp, KW, Bom, JG, Adriaanse, HJ, Akker, ESA, Baas, MI, Bank, CMC, Beek, E, de Boer, BAG, Boer, K, van der Borden, DMR, Bremer, HA, Brons, JTJ, Burggraaff, JM, Ceelie, H, Chon, H, Cikot, JLM, Delemarre, FMC, Diris, JHC, Doesburg-van Kleffens, M, van Dooren, IMA, van Duijnhoven, JLP, van Dunn, FM, Duvekot, J.J., Engbers, P, Hulst, MJW, Feitsma, H, Fouraux, MA, Franssen, MT, Frasa, MAM, van Gammeren, AJ, Gemund, N, Graaf, F, Groot, CJM, Hackeng, CM, van der Ham, DP, Hanssen, M, Hasaart, THM, Hendriks, HA, Henskens, YMC, Hermsen, BBJ, Hogenboom, S, Hooker, A, Hudig, F, Huijssoon, AMG, Huisjes, AJM, Jonker, N, Kabel, PJ, van Kampen, C, de Keijzer, MH, van de Kerkhof, DH, Keuren, JFW, Kleiverda, G, Klinkspoor, JH, Koehorst, SGA, Kok, M, Kok, RD, de Kok, JB, Koops, A, Kortlandt, W, Langenveld, J, Leers, MPG, Leyte, A, de Mare, A, Martens, GDM, Meekers, JH, van Meir, CA, Metz, GCH, Michielse, E, Mostert, LJ, Bijvank, S, Oostenveld, E, Osmanovic, N, Oudijk, MA, Mirani-Oostdijk, CP, van Pampus, E C M, Papatsonis, DNM, Peters, RHM, Ponjee, GA, Pontesilli, M, Porath, MM, Post, MS, Pouwels, JGJ, Prinzen, L, Roelofsen, JMT, Rondeel, JJM, van der Salm, PCM, Scheepers, HCJ, Schippers, DH, Schuitemaker, NWE, Sikkema, JM, Slomp, J, Smit, JWA, Snuif-de Lange, YS, van der Stappen, JWJ, Steures, P, Tax, GHM, Treskes, M, Ulenkate, H, van Unnik, GA, van der Veen, BS, Verhagen, TEM, Versendaal, J, Visschers, B, Visser, O, Visser, H, De Vooght, KMK, Vries, MJ, Waard, H, Weerkamp, F, Weinans, MJN, de Wet, H, Wijnen, M (Mandy), van Wijngaarden, WJ, de Wit, AC, Woiski, MD, TeMp, OHSG, Henriquez, D, Gillissen, A, Smith, SM, Cramer, RA, van den Akker, T, Zwart, JJ, van Roosmalen, JJ, Bloemenkamp, KW, Bom, JG, Adriaanse, HJ, Akker, ESA, Baas, MI, Bank, CMC, Beek, E, de Boer, BAG, Boer, K, van der Borden, DMR, Bremer, HA, Brons, JTJ, Burggraaff, JM, Ceelie, H, Chon, H, Cikot, JLM, Delemarre, FMC, Diris, JHC, Doesburg-van Kleffens, M, van Dooren, IMA, van Duijnhoven, JLP, van Dunn, FM, Duvekot, J.J., Engbers, P, Hulst, MJW, Feitsma, H, Fouraux, MA, Franssen, MT, Frasa, MAM, van Gammeren, AJ, Gemund, N, Graaf, F, Groot, CJM, Hackeng, CM, van der Ham, DP, Hanssen, M, Hasaart, THM, Hendriks, HA, Henskens, YMC, Hermsen, BBJ, Hogenboom, S, Hooker, A, Hudig, F, Huijssoon, AMG, Huisjes, AJM, Jonker, N, Kabel, PJ, van Kampen, C, de Keijzer, MH, van de Kerkhof, DH, Keuren, JFW, Kleiverda, G, Klinkspoor, JH, Koehorst, SGA, Kok, M, Kok, RD, de Kok, JB, Koops, A, Kortlandt, W, Langenveld, J, Leers, MPG, Leyte, A, de Mare, A, Martens, GDM, Meekers, JH, van Meir, CA, Metz, GCH, Michielse, E, Mostert, LJ, Bijvank, S, Oostenveld, E, Osmanovic, N, Oudijk, MA, Mirani-Oostdijk, CP, van Pampus, E C M, Papatsonis, DNM, Peters, RHM, Ponjee, GA, Pontesilli, M, Porath, MM, Post, MS, Pouwels, JGJ, Prinzen, L, Roelofsen, JMT, Rondeel, JJM, van der Salm, PCM, Scheepers, HCJ, Schippers, DH, Schuitemaker, NWE, Sikkema, JM, Slomp, J, Smit, JWA, Snuif-de Lange, YS, van der Stappen, JWJ, Steures, P, Tax, GHM, Treskes, M, Ulenkate, H, van Unnik, GA, van der Veen, BS, Verhagen, TEM, Versendaal, J, Visschers, B, Visser, O, Visser, H, De Vooght, KMK, Vries, MJ, Waard, H, Weerkamp, F, Weinans, MJN, de Wet, H, Wijnen, M (Mandy), van Wijngaarden, WJ, de Wit, AC, Woiski, MD, and TeMp, OHSG
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- 2019
7. Balloon catheter for induction of labor in women with one previous cesarean and an unfavorable cervix
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Huisman, CMA, ten Eikelder, MLG, Mast, K, Rengerink, KO, Jozwiak, M, Dunne, F, Duvekot, J.J., Eyck, J, Gaugler-Senden, I, Groot, CJM, Franssen, MTM, Gemund, Nicolette, Langenveld, J, Leeuw, JW, Lohuis, EJO, Oudijk, MA, Papatsonis, D, van Pampus, M, Porath, M, de Weerd, S, van Roosmalen, JJ, van der Salm, PCM, Scheepers, HCJ, Sikkema, MJ, Sporken, J, Stigter, RH, van Wijngaarden, WJ, Woiski, M, Mol, BWJ (Ben), Bloemenkamp, KWM, Huisman, CMA, ten Eikelder, MLG, Mast, K, Rengerink, KO, Jozwiak, M, Dunne, F, Duvekot, J.J., Eyck, J, Gaugler-Senden, I, Groot, CJM, Franssen, MTM, Gemund, Nicolette, Langenveld, J, Leeuw, JW, Lohuis, EJO, Oudijk, MA, Papatsonis, D, van Pampus, M, Porath, M, de Weerd, S, van Roosmalen, JJ, van der Salm, PCM, Scheepers, HCJ, Sikkema, MJ, Sporken, J, Stigter, RH, van Wijngaarden, WJ, Woiski, M, Mol, BWJ (Ben), and Bloemenkamp, KWM
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- 2019
8. Longitudinal study of computerised cardiotocography in early fetal growth restriction
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Wolf, H, Arabin, B, Lees, CC, Oepkes, D, Prefumo, F, Thilaganathan, B, Todros, T, Visser, GHA, Bilardo, CM, Derks, JB, Diemert, A, Duvekot, JJ, Ferrazzi, E, Frusca, T, Hecher, K, Marlow, N, Martinelli, P, Ostermayer, E, Papageorghiou, AT, Scheepers, HCJ, Schlembach, D, Schneider, KTM, Valcamonico, A, van Wassenaer-Leemhuis, A, and Ganzevoort, W
- Abstract
OBJECTIVES: To explore if in early fetal growth restriction (FGR) the longitudinal pattern of short-term fetal heart rate (FHR) variation (STV) can be used for identifying imminent fetal distress and if abnormalities of FHR registration associate with two-year infant outcome. METHODS: The original TRUFFLE study assessed if in early FGR the use of ductus venosus Doppler pulsatility index (DVPI), in combination with a safety-net of very low STV and / or recurrent decelerations, could improve two-year infant survival without neurological impairment in comparison to computerised cardiotocography (cCTG) with STV calculation only. For this secondary analysis we selected women, who delivered before 32 weeks, and who had consecutive STV data for more than 3 days before delivery, and known infant two-year outcome data. Women who received corticosteroids within 3 days of delivery were excluded. Individual regression line algorithms of all STV values except the last one were calculated. Life table analysis and Cox regression analysis were used to calculate the day by day risk for a low STV or very low STV and / or FHR decelerations (DVPI group safety-net) and to assess which parameters were associated to this risk. Furthermore, it was assessed if STV pattern, lowest STV value or recurrent FHR decelerations were associated with two-year infant outcome. RESULTS: One hundred and fourty-nine women matched the inclusion criteria. Using the individual STV regression lines prediction of a last STV below the cCTG-group cut-off had a sensitivity of 0.42 and specificity of 0.91. For each day after inclusion the median risk for a low STV(cCTG criteria) was 4% (Interquartile range (IQR) 2% to 7%) and for a very low STV and / or recurrent decelerations (DVPI safety-net criteria) 5% (IQR 4 to 7%). Measures of STV pattern, fetal Doppler (arterial or venous), birthweight MoM or gestational age did not improve daily risk prediction usefully. There was no association of STV regression coefficients, a last low STV or /and recurrent decelerations with short or long term infant outcomes. CONCLUSION: The TRUFFLE study showed that a strategy of DVPI monitoring with a safety-net delivery indication of very low STV and / or recurrent decelerations could increase infant survival without neurological impairment at two years. This post-hoc analysis demonstrates that in early FGR the day by day risk of an abnormal cCTG as defined by the DVPI protocol safety-net criteria is 5%, and that prediction of this is not possible. This supports the rationale for cCTG monitoring more often than daily in these high-risk fetuses. Low STV and/or recurrent decelerations were not associated with adverse infant outcome and it appears safe to delay intervention until such abnormalities occur, as long as DVPI is in the normal range.
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- 2017
9. External validation and clinical usefulness of first‐trimester prediction models for small‐ and large‐for‐gestational‐age infants: a prospective cohort study
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Meertens, LJE, primary, Smits, LJM, additional, Kuijk, SMJ, additional, Aardenburg, R, additional, Dooren, IMA, additional, Langenveld, J, additional, Zwaan, IM, additional, Spaanderman, MEA, additional, and Scheepers, HCJ, additional
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- 2019
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10. Maternal and neonatal outcomes in women with severe early onset pre-eclampsia before 26 weeks of gestation, a case series
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van Oostwaard, M F, van Eerden, L, de Laat, M W, Duvekot, J J, Erwich, Jjhm, Bloemenkamp, Kwm, Bolte, A C, Bosma, Jpf, Koenen, S V, Kornelisse, R F, Rethans, B, van Runnard Heimel, P, Scheepers, Hcj, Ganzevoort, W, Mol, Bwj, de Groot, C J, Gaugler-Senden, Ipm, van Oostwaard, M F, van Eerden, L, de Laat, M W, Duvekot, J J, Erwich, Jjhm, Bloemenkamp, Kwm, Bolte, A C, Bosma, Jpf, Koenen, S V, Kornelisse, R F, Rethans, B, van Runnard Heimel, P, Scheepers, Hcj, Ganzevoort, W, Mol, Bwj, de Groot, C J, and Gaugler-Senden, Ipm
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- 2017
11. Maternal and neonatal outcomes in women with severe early onset pre-eclampsia before 26 weeks of gestation, a case series
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Unit Opleiding Aios, Geboortecentrum voorzitterschap, MS Verloskunde, Circulatory Health, van Oostwaard, M F, van Eerden, L, de Laat, M W, Duvekot, J J, Erwich, Jjhm, Bloemenkamp, Kwm, Bolte, A C, Bosma, Jpf, Koenen, S V, Kornelisse, R F, Rethans, B, van Runnard Heimel, P, Scheepers, Hcj, Ganzevoort, W, Mol, Bwj, de Groot, C J, Gaugler-Senden, Ipm, Unit Opleiding Aios, Geboortecentrum voorzitterschap, MS Verloskunde, Circulatory Health, van Oostwaard, M F, van Eerden, L, de Laat, M W, Duvekot, J J, Erwich, Jjhm, Bloemenkamp, Kwm, Bolte, A C, Bosma, Jpf, Koenen, S V, Kornelisse, R F, Rethans, B, van Runnard Heimel, P, Scheepers, Hcj, Ganzevoort, W, Mol, Bwj, de Groot, C J, and Gaugler-Senden, Ipm
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- 2017
12. Maternal and neonatal outcomes in women with severe early onset pre-eclampsia before 26 weeks of gestation, a case series
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van Oostwaard, MF, primary, van Eerden, L, additional, de Laat, MW, additional, Duvekot, JJ, additional, Erwich, JJHM, additional, Bloemenkamp, KWM, additional, Bolte, AC, additional, Bosma, JPF, additional, Koenen, SV, additional, Kornelisse, RF, additional, Rethans, B, additional, van Runnard Heimel, P, additional, Scheepers, HCJ, additional, Ganzevoort, W, additional, Mol, BWJ, additional, de Groot, CJ, additional, and Gaugler-Senden, IPM, additional
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- 2017
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13. Maintenance tocolysis with nifedipine in threatened preterm labour: 2-year follow up of the offspring in the APOSTEL II trial
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Van Vliet, Eog, Seinen, L, Roos, C, Schuit, E, Scheepers, Hcj, Bloemenkamp, Kwm, Duvekot, Jj, Van Eyck, J, Kok, Jh, Lotgering, Fk, Van Baar, A, Van Wassenaer-leemhuis, Ag, Franssen, Mt, Porath, Mm, Van Der Post, Jam, Franx, A, Mol, Bwj, Oudijk, Ma, Van Vliet, Eog, Seinen, L, Roos, C, Schuit, E, Scheepers, Hcj, Bloemenkamp, Kwm, Duvekot, Jj, Van Eyck, J, Kok, Jh, Lotgering, Fk, Van Baar, A, Van Wassenaer-leemhuis, Ag, Franssen, Mt, Porath, Mm, Van Der Post, Jam, Franx, A, Mol, Bwj, and Oudijk, Ma
- Abstract
Objective To evaluate long-term effects of maintenance tocolysis with nifedipine on neurodevelopmental outcome of the infant. Design, Setting and Population Follow up of infants of women who participated in a multicentre randomised controlled trial on maintenance tocolysis with nifedipine versus placebo. Methods Two years after the APOSTEL II trial on maintenance tocolysis with nifedipine versus placebo, we asked participants to complete the Ages and Stages Questionnaire. Main outcome measures Infant development was measured in five domains. Developmental delay was defined as a score of ≤1 SD in one or more developmental domains. We performed exploratory subgroup analysis in women with preterm prolonged rupture of the membranes, and in women with a cervical length <10 mm at study entry. Results Of the 276 women eligible for follow up, 135 (52.5%) returned the questionnaire, encompassing data of 170 infants. At 2 years of age, infants of women with nifedipine maintenance tocolysis compared with placebo had a higher overall incidence of fine motor problems (22.2 versus 7.6%, OR 3.43, 95% CI 1.29–9.14, P = 0.01), and a lower incidence of poor problem-solving (21.1 versus 29.1%, OR 0.27, 95% CI 0.08-0.95, P = 0.04). Conclusions This follow-up study revealed no clear benefit of nifedipine maintenance tocolysis at 2 years of age. As short-term adverse perinatal outcome was not reduced in the original APOSTEL II trial, we conclude that maintenance tocolysis does not appear to be beneficial at this time. Tweetable abstract No clear benefit of nifedipine maintenance tocolysis in preterm labour on 2-year infant outcome.
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- 2016
14. Quantitative fetal fibronectin testing in combination with cervical length measurement in the prediction of spontaneous preterm delivery in symptomatic women
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Bruijn, Mmc, Vis, J Y, Wilms, F F, Oudijk, M A, Kwee, A, Porath, M M, Oei, G, Scheepers, Hcj, Spaanderman, Mea, Bloemenkamp, Kwm, Haak, M C, Bolte, A C, Vandenbussche, Fpha, Woiski, M D, Bax, C J, Cornette, Jmj, Duvekot, J J, Nij Bijvanck, Bwa, van Eyck, J, Franssen, Mtm, Sollie, K M, van der Post, Jam, Bossuyt, Pmm, Opmeer, B C, Kok, M., Mol, Bwj, van Baaren, G-J, Bruijn, Mmc, Vis, J Y, Wilms, F F, Oudijk, M A, Kwee, A, Porath, M M, Oei, G, Scheepers, Hcj, Spaanderman, Mea, Bloemenkamp, Kwm, Haak, M C, Bolte, A C, Vandenbussche, Fpha, Woiski, M D, Bax, C J, Cornette, Jmj, Duvekot, J J, Nij Bijvanck, Bwa, van Eyck, J, Franssen, Mtm, Sollie, K M, van der Post, Jam, Bossuyt, Pmm, Opmeer, B C, Kok, M., Mol, Bwj, and van Baaren, G-J
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- 2016
15. Maintenance tocolysis with nifedipine in threatened preterm labour: 2-year follow up of the offspring in the APOSTEL II trial
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Leerstoel Baar, Development and Treatment of Psychosocial Problems, Van Vliet, Eog, Seinen, L, Roos, C, Schuit, E, Scheepers, Hcj, Bloemenkamp, Kwm, Duvekot, Jj, Van Eyck, J, Kok, Jh, Lotgering, Fk, Van Baar, A, Van Wassenaer-leemhuis, Ag, Franssen, Mt, Porath, Mm, Van Der Post, Jam, Franx, A, Mol, Bwj, Oudijk, Ma, Leerstoel Baar, Development and Treatment of Psychosocial Problems, Van Vliet, Eog, Seinen, L, Roos, C, Schuit, E, Scheepers, Hcj, Bloemenkamp, Kwm, Duvekot, Jj, Van Eyck, J, Kok, Jh, Lotgering, Fk, Van Baar, A, Van Wassenaer-leemhuis, Ag, Franssen, Mt, Porath, Mm, Van Der Post, Jam, Franx, A, Mol, Bwj, and Oudijk, Ma
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- 2016
16. Quantitative fetal fibronectin testing in combination with cervical length measurement in the prediction of spontaneous preterm delivery in symptomatic women
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CDL Klinisch Chemici in opleiding, Circulatory Health, Other research (not in main researchprogram), MS Verloskunde, Bruijn, Mmc, Vis, J Y, Wilms, F F, Oudijk, M A, Kwee, A, Porath, M M, Oei, G, Scheepers, Hcj, Spaanderman, Mea, Bloemenkamp, Kwm, Haak, M C, Bolte, A C, Vandenbussche, Fpha, Woiski, M D, Bax, C J, Cornette, Jmj, Duvekot, J J, Nij Bijvanck, Bwa, van Eyck, J, Franssen, Mtm, Sollie, K M, van der Post, Jam, Bossuyt, Pmm, Opmeer, B C, Kok, M., Mol, Bwj, van Baaren, G-J, CDL Klinisch Chemici in opleiding, Circulatory Health, Other research (not in main researchprogram), MS Verloskunde, Bruijn, Mmc, Vis, J Y, Wilms, F F, Oudijk, M A, Kwee, A, Porath, M M, Oei, G, Scheepers, Hcj, Spaanderman, Mea, Bloemenkamp, Kwm, Haak, M C, Bolte, A C, Vandenbussche, Fpha, Woiski, M D, Bax, C J, Cornette, Jmj, Duvekot, J J, Nij Bijvanck, Bwa, van Eyck, J, Franssen, Mtm, Sollie, K M, van der Post, Jam, Bossuyt, Pmm, Opmeer, B C, Kok, M., Mol, Bwj, and van Baaren, G-J
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- 2016
17. Early nasogastric tube feeding in optimising treatment for hyperemesis gravidarum: the MOTHER randomised controlled trial (Maternal and Offspring outcomes after Treatment of HyperEmesis by Refeeding)
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Grooten, IJ, Mol, BW, van der Post, JAM, Ris-Stalpers, C, Kok, M, Bais, JMJ, Bax, CJ, Duvekot, J.J., Bremer, HA, Porath, MM, Heidema, WM, Bloemenkamp, KWM, Scheepers, HCJ, Franssen, MTM, Oudijk, MA, Roseboom, TJ, Painter, RC, Grooten, IJ, Mol, BW, van der Post, JAM, Ris-Stalpers, C, Kok, M, Bais, JMJ, Bax, CJ, Duvekot, J.J., Bremer, HA, Porath, MM, Heidema, WM, Bloemenkamp, KWM, Scheepers, HCJ, Franssen, MTM, Oudijk, MA, Roseboom, TJ, and Painter, RC
- Abstract
Background: Hyperemesis gravidarum (HG), or intractable vomiting during pregnancy, is the single most frequent cause of hospital admission in early pregnancy. HG has a major impact on maternal quality of life and has repeatedly been associated with poor pregnancy outcome such as low birth weight. Currently, women with HG are admitted to hospital for intravenous fluid replacement, without receiving specific nutritional attention. Nasogastric tube feeding is sometimes used as last resort treatment. At present no randomised trials on dietary or rehydration interventions have been performed. Small observational studies indicate that enteral tube feeding may have the ability to effectively treat dehydration and malnutrition and alleviate nausea and vomiting symptoms. We aim to evaluate the effectiveness of early enteral tube feeding in addition to standard care on nausea and vomiting symptoms and pregnancy outcomes in HG patients. Methods/Design: The MOTHER trial is a multicentre open label randomised controlled trial (www.studies-obsgyn.nl/mother). Women >= 18 years hospitalised for HG between 5 + 0 and 19 + 6 weeks gestation are eligible for participation. After informed consent participants are randomly allocated to standard care with intravenous rehydration or early enteral tube feeding in addition to standard care. All women keep a weekly diary to record symptoms and dietary intake until 20 weeks gestation. The primary outcome will be neonatal birth weight. Secondary outcomes will be the 24-h Pregnancy Unique Quantification of Emesis and nausea score (PUQE-24), maternal weight gain, dietary intake, duration of hospital stay, number of readmissions, quality of life and side-effects. Also gestational age at birth, placental weight, umbilical cord plasma lipid concentration and neonatal morbidity will be evaluated. Analysis will be according to the intention to treat principle. Discussion: With this trial we aim to clarify whether early enteral tube feeding is more eff
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- 2016
18. Development and Measurement of Guidelines-Based Quality Indicators of Caesarean Section Care in the Netherlands: A RAND-Modified Delphi Procedure and Retrospective Medical Chart Review
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Melman, S, Schoorel, ECN, de Boer, K, Burggraaf, H, Derks, JB, van Dijk, D, van Dillen, J, Dirksen, CD, Duvekot, J.J., Franx, A, Hasaart, THM, Huisjes, AJM, Kolkman, D, van Kuijk, S, Kwee, A, Mol, BW, van Pampus, MG, de Roon-Immerzeel, A, van Roosmalen, JJM, Roumen, FJME, Smid-Koopman, E, Smits, L, Spaans, WA, Visser, H, van Wijngaarden, WJ, Willekes, C, Wouters, MGAJ, Nijhuis, JG, Hermens, RPMG, Scheepers, HCJ, Melman, S, Schoorel, ECN, de Boer, K, Burggraaf, H, Derks, JB, van Dijk, D, van Dillen, J, Dirksen, CD, Duvekot, J.J., Franx, A, Hasaart, THM, Huisjes, AJM, Kolkman, D, van Kuijk, S, Kwee, A, Mol, BW, van Pampus, MG, de Roon-Immerzeel, A, van Roosmalen, JJM, Roumen, FJME, Smid-Koopman, E, Smits, L, Spaans, WA, Visser, H, van Wijngaarden, WJ, Willekes, C, Wouters, MGAJ, Nijhuis, JG, Hermens, RPMG, and Scheepers, HCJ
- Abstract
Background There is an ongoing discussion on the rising CS rate worldwide. Suboptimal guideline adherence may be an important contributor to this rise. Before improvement of care can be established, optimal CS care in different settings has to be defined. This study aimed to develop and measure quality indicators to determine guideline adherence and identify target groups for improvement of care with direct effect on caesarean section (CS) rates. Method Eighteen obstetricians and midwives participated in an expert panel for systematic CS quality indicator development according to the RAND-modified Delphi method. A multi-center study was performed and medical charts of 1024 women with a CS and a stratified and weighted randomly selected group of 1036 women with a vaginal delivery were analysed. Quality indicator frequency and adherence were scored in 2060 women with a CS or vaginal delivery. Results The expert panel developed 16 indicators on planned CS and 11 indicators on unplanned CS. Indicator adherence was calculated, defined as the number of women in a specific obstetrical situation in which care was performed as recommended in both planned and unplanned CS settings. The most frequently occurring obstetrical situations with low indicator adherence were: 1) suspected fetal distress (frequency 17%, adherence 46%), 2) nonprogressive labour (frequency 12%, CS performed too early in over 75%), 3) continuous support during labour (frequency 88%, adherence 37%) and 4) previous CS (frequency 12%), with adequate counselling in 15%. Conclusions We identified four concrete target groups for improvement of obstetrical care, which can be used as a starting point to reduce CS rates worldwide.
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- 2016
19. Borstvoeding en geneesmiddelen rond de partus
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de Wildt, Saskia, Scheepers, HCJ, Anten-Kools, E.J., van Wouwe, J.P., Oudesluys-Murphy, A.M., Semmekrot, B.A., Pediatric Surgery, and Pediatrics
- Published
- 2011
20. Quantitative fetal fibronectin testing in combination with cervical length measurement in the prediction of spontaneous preterm delivery in symptomatic women
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Bruijn, MMC, primary, Vis, JY, additional, Wilms, FF, additional, Oudijk, MA, additional, Kwee, A, additional, Porath, MM, additional, Oei, G, additional, Scheepers, HCJ, additional, Spaanderman, MEA, additional, Bloemenkamp, KWM, additional, Haak, MC, additional, Bolte, AC, additional, Vandenbussche, FPHA, additional, Woiski, MD, additional, Bax, CJ, additional, Cornette, JMJ, additional, Duvekot, JJ, additional, Nij Bijvanck, BWA, additional, van Eyck, J, additional, Franssen, MTM, additional, Sollie, KM, additional, van der Post, JAM, additional, Bossuyt, PMM, additional, Opmeer, BC, additional, Kok, M, additional, Mol, BWJ, additional, and van Baaren, G-J, additional
- Published
- 2015
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21. Maintenance tocolysis with nifedipine in threatened preterm labour: 2‐year follow up of the offspring in the APOSTEL II trial
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Vliet, EOG, primary, Seinen, L, additional, Roos, C, additional, Schuit, E, additional, Scheepers, HCJ, additional, Bloemenkamp, KWM, additional, Duvekot, JJ, additional, Eyck, J, additional, Kok, JH, additional, Lotgering, FK, additional, Baar, A, additional, Wassenaer‐Leemhuis, AG, additional, Franssen, MT, additional, Porath, MM, additional, Post, JAM, additional, Franx, A, additional, Mol, BWJ, additional, and Oudijk, MA, additional
- Published
- 2015
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22. Maternal and neonatal outcomes in women with severe early onset pre-eclampsia before 26 weeks of gestation, a case series.
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Oostwaard, MF, Eerden, L, Laat, MW, Duvekot, JJ, Erwich, JJHM, Bloemenkamp, KWM, Bolte, AC, Bosma, JPF, Koenen, SV, Kornelisse, RF, Rethans, B, Runnard Heimel, P, Scheepers, HCJ, Ganzevoort, W, Mol, BWJ, Groot, CJ, Gaugler‐Senden, IPM, van Oostwaard, M F, van Eerden, L, and de Laat, M W
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PREGNANCY ,EDEMA ,PLACENTA ,RETROLENTAL fibroplasia ,KIDNEY failure - Abstract
Objective: To describe the maternal and neonatal outcomes and prolongation of pregnancies with severe early onset pre-eclampsia before 26 weeks of gestation.Design: Nationwide case series.Setting: All Dutch tertiary perinatal care centres.Population: All women diagnosed with severe pre-eclampsia who delivered between 22 and 26 weeks of gestation in a tertiary perinatal care centre in the Netherlands, between 2008 and 2014.Methods: Women were identified through computerised hospital databases. Data were collected from medical records.Main Outcome Measures: Maternal complications [HELLP (haemolysis, elevated liver enzyme levels, and low platelet levels) syndrome, eclampsia, pulmonary oedema, cerebrovascular incidents, hepatic capsular rupture, placenta abruption, renal failure, and maternal death], neonatal survival and complications (intraventricular haemorrhage, retinopathy of prematurity, necrotising enterocolitis, bronchopulmonary dysplasia, and sepsis), and outcome of subsequent pregnancies (recurrent pre-eclampsia, premature delivery, and neonatal survival).Results: We studied 133 women, delivering 140 children. Maternal complications occurred frequently (54%). Deterioration of HELLP syndrome during expectant care occurred in 48%, after 4 days. Median prolongation was 5 days (range: 0-25 days). Neonatal survival was poor (19%), and was worse (6.6%) if the mother was admitted before 24 weeks of gestation. Complications occurred frequently among survivors (84%). After active support, neonatal survival was comparable with the survival of spontaneous premature neonates (54%). Pre-eclampsia recurred in 31%, at a mean gestational age of 32 weeks and 6 days.Conclusions: Considering the limits of prolongation, women need to be counselled carefully, weighing the high risk for maternal complications versus limited neonatal survival and/or extreme prematurity and its sequelae. The positive prospects regarding maternal and neonatal outcome in future pregnancies can supplement counselling.Tweetable Abstract: Severe early onset pre-eclampsia comes with high maternal complication rates and poor neonatal survival. [ABSTRACT FROM AUTHOR]- Published
- 2017
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23. Routine labour epidural analgesia versus labour analgesia on request: a randomised non‐inferiority trial
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Wassen, MMLH, primary, Smits, LJM, additional, Scheepers, HCJ, additional, Marcus, MAE, additional, Van Neer, J, additional, Nijhuis, JG, additional, and Roumen, FJME, additional
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- 2014
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24. Pessaries in multiple pregnancy as a prevention of preterm birth: the ProTwin Trial (vol 9, 44, 2009)
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Liem, SMS, Bekedam, DJ, Bloemenkamp, KWM, Kwee, A, Papatsonis, Dimitri, van der Post, JAM, Lim, AC, Scheepers, HCJ, Willekes, C, Duvekot, J.J., Spaanderman, M, Porath, M, van Eyck, J, Haak, MC, van Pampus, MG, Bruinse, HW, Mol, BWJ (Ben), Hegeman, MA, Liem, SMS, Bekedam, DJ, Bloemenkamp, KWM, Kwee, A, Papatsonis, Dimitri, van der Post, JAM, Lim, AC, Scheepers, HCJ, Willekes, C, Duvekot, J.J., Spaanderman, M, Porath, M, van Eyck, J, Haak, MC, van Pampus, MG, Bruinse, HW, Mol, BWJ (Ben), and Hegeman, MA
- Published
- 2012
25. Study protocol: Cost effectiveness of two strategies to implement the NVOG guidelines on hypertension in pregnancy: An innovative strategy including a computerised decision support system compared to a common strategy of professional audit and feedback, a randomized controlled trial
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Luitjes, SHE (Susanne), Wouters, MGAJ, Franx, A (Arie), Scheepers, HCJ, Coupe, VMH (Veerle), Wollersheim, H, Steegers, Eric, Heringa, MP, Hermens, RPMG, van Tulder, MW, Luitjes, SHE (Susanne), Wouters, MGAJ, Franx, A (Arie), Scheepers, HCJ, Coupe, VMH (Veerle), Wollersheim, H, Steegers, Eric, Heringa, MP, Hermens, RPMG, and van Tulder, MW
- Abstract
Background: Hypertensive disease in pregnancy remains the leading cause of maternal mortality in the Netherlands. Seventeen percent of the clinical pregnancies are complicated by hypertension and 2% by preeclampsia. The Dutch Society of Obstetrics and Gynaecology (NVOG) has developed evidence-based guidelines on the management of hypertension in pregnancy and chronic hypertension. Previous studies showed a low adherence rate to other NVOG guidelines and a large variation in usual care in the different hospitals. An explanation is that the NVOG has no general strategy of practical implementation and evaluation of its guidelines. The development of an effective and cost effective implementation strategy to improve adherence to the guidelines on hypertension in pregnancy is needed. Methods/Design: The objective of this study is to assess the cost effectiveness of an innovative implementation strategy of the NVOG guidelines on hypertension including a computerised decision support system (BOS) compared to a common strategy of professional audit and feedback. A cluster randomised controlled trial with an economic evaluation alongside will be performed. Both pregnant women who develop severe hypertension or pre-eclampsia and professionals involved in the care for these women will participate. The main outcome measures are a combined rate of major maternal complications and process indicators extracted from the guidelines. A total of 472 patients will be included in both groups. For analysis, descriptive as well as regression techniques will be used. A cost effectiveness and cost utility analysis will be performed according to the intention-to-treat principle and from a societal perspective. Cost effectiveness ratios will be calculated using bootstrapping techniques.
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- 2010
26. Pessaries in multiple pregnancy as a prevention of preterm birth: the ProTwin Trial
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Hegeman, MA, Bekedam, DJ, Bloemenkamp, KWM, Kwee, A, Papatsonis, Dimitri, Van der Post, JAM, Lim, AC, Scheepers, HCJ, Willekes, C, Duvekot, J.J., Spaanderman, M, Porath, MM, van Eyck, J, Haak, MC, van Pampus, MG, Bruinse, HW, Mol, BWJ (Ben), Hegeman, MA, Bekedam, DJ, Bloemenkamp, KWM, Kwee, A, Papatsonis, Dimitri, Van der Post, JAM, Lim, AC, Scheepers, HCJ, Willekes, C, Duvekot, J.J., Spaanderman, M, Porath, MM, van Eyck, J, Haak, MC, van Pampus, MG, Bruinse, HW, and Mol, BWJ (Ben)
- Published
- 2009
27. Predicting successful intended vaginal delivery after previous caesarean section: external validation of two predictive models in a Dutch nationwide registration-based cohort with a high intended vaginal delivery rate
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Schoorel, ENC, primary, Melman, S, additional, van Kuijk, SMJ, additional, Grobman, WA, additional, Kwee, A, additional, Mol, BWJ, additional, Nijhuis, JG, additional, Smits, LJM, additional, Aardenburg, R, additional, de Boer, K, additional, Delemarre, FMC, additional, van Dooren, IM, additional, Franssen, MTM, additional, Kleiverda, G, additional, Kaplan, M, additional, Kuppens, SMI, additional, Lim, FTH, additional, Sikkema, JM, additional, Smid-Koopman, E, additional, Visser, H, additional, Vrouenraets, FPJM, additional, Woiski, M, additional, Hermens, RPMG, additional, and Scheepers, HCJ, additional
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- 2014
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28. Transfusion policy after severe postpartum haemorrhage: a randomised non-inferiority trial
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Prick, BW, primary, Jansen, AJG, additional, Steegers, EAP, additional, Hop, WCJ, additional, Essink-Bot, ML, additional, Uyl-de Groot, CA, additional, Akerboom, BMC, additional, van Alphen, M, additional, Bloemenkamp, KWM, additional, Boers, KE, additional, Bremer, HA, additional, Kwee, A, additional, van Loon, AJ, additional, Metz, GCH, additional, Papatsonis, DNM, additional, van der Post, JAM, additional, Porath, MM, additional, Rijnders, RJP, additional, Roumen, FJME, additional, Scheepers, HCJ, additional, Schippers, DH, additional, Schuitemaker, NWE, additional, Stigter, RH, additional, Woiski, MD, additional, Mol, BWJ, additional, van Rhenen, DJ, additional, and Duvekot, JJ, additional
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- 2014
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29. Involving women in personalised decision-making on mode of delivery after caesarean section: the development and pilot testing of a patient decision aid
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Schoorel, ENC, primary, Vankan, E, additional, Scheepers, HCJ, additional, Augustijn, BCC, additional, Dirksen, CD, additional, de Koning, M, additional, van Kuijk, SMJ, additional, Kwee, A, additional, Melman, S, additional, Nijhuis, JG, additional, Aardenburg, R, additional, de Boer, K, additional, Hasaart, THM, additional, Mol, BWJ, additional, Nieuwenhuijze, M, additional, van Pampus, MG, additional, van Roosmalen, J, additional, Roumen, FJME, additional, de Vries, R, additional, Wouters, MGAJ, additional, van der Weijden, T, additional, and Hermens, RPMG, additional
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- 2013
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30. Vaginal birth after a caesarean section: the development of a Western European population‐based prediction model for deliveries at term
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Schoorel, ENC, primary, van Kuijk, SMJ, additional, Melman, S, additional, Nijhuis, JG, additional, Smits, LJM, additional, Aardenburg, R, additional, de Boer, K, additional, Delemarre, FMC, additional, van Dooren, IM, additional, Franssen, MTM, additional, Kaplan, M, additional, Kleiverda, G, additional, Kuppens, SMI, additional, Kwee, A, additional, Lim, FTH, additional, Mol, BWJ, additional, Roumen, FJME, additional, Sikkema, JM, additional, Smid‐Koopman, E, additional, Visser, H, additional, Woiski, M, additional, Hermens, RPMG, additional, and Scheepers, HCJ, additional
- Published
- 2013
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31. Cost-effectiveness of induction of labour at term with a Foley catheter compared to vaginal prostaglandin E2gel (PROBAAT trial)
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van Baaren, GJ, primary, Jozwiak, M, additional, Opmeer, BC, additional, Oude Rengerink, K, additional, Benthem, M, additional, Dijksterhuis, MGK, additional, van Huizen, ME, additional, van der Salm, PCM, additional, Schuitemaker, NWE, additional, Papatsonis, DNM, additional, Perquin, DAM, additional, Porath, M, additional, van der Post, JAM, additional, Rijnders, RJP, additional, Scheepers, HCJ, additional, Spaanderman, M, additional, van Pampus, MG, additional, de Leeuw, JW, additional, Mol, BWJ, additional, and Bloemenkamp, KWM, additional
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- 2013
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32. Induction of labour versus expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks (the PPROMEXIL-trial)
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van der Ham, DP, Nijhuis, JG, Mol, BWJ (Ben), van Beek, JJ, Opmeer, BC, Bijlenga, D, Groenewout, M (Mariette), Arabin, B, Bloemenkamp, KWM, van Wijngaarden, WJ, Wouters, MGAJ, Pernet, PJM, Porath, MM, Molkenboer, JFM, Derks, JB, Kars, MM, Scheepers, HCJ, Weinans, MJN, Woiski, MD, Wildschut, Hajo, Willekes, C, van der Ham, DP, Nijhuis, JG, Mol, BWJ (Ben), van Beek, JJ, Opmeer, BC, Bijlenga, D, Groenewout, M (Mariette), Arabin, B, Bloemenkamp, KWM, van Wijngaarden, WJ, Wouters, MGAJ, Pernet, PJM, Porath, MM, Molkenboer, JFM, Derks, JB, Kars, MM, Scheepers, HCJ, Weinans, MJN, Woiski, MD, Wildschut, Hajo, and Willekes, C
- Published
- 2007
33. Disproportionate intrauterine growth intervention trial at term: DIGITAT
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Boers, KE, Bijlenga, D, Mol, BWJ (Ben), le Cessie, S, Birnie, Erwin, van Pampus, MG, Stigter, RH, Bloemenkamp, KWM, van Meir, CA, Van der Post, JAM, Bekedam, DJ, Ribbert, LSM, Drogtrop, AP, van der Salm, PCM, Huisjes, AJM, Willekes, C, Roumen, FJME, Scheepers, HCJ, de Boer, K, Duvekot, JJ, Thornton, JG, Scherjon, SA, Boers, KE, Bijlenga, D, Mol, BWJ (Ben), le Cessie, S, Birnie, Erwin, van Pampus, MG, Stigter, RH, Bloemenkamp, KWM, van Meir, CA, Van der Post, JAM, Bekedam, DJ, Ribbert, LSM, Drogtrop, AP, van der Salm, PCM, Huisjes, AJM, Willekes, C, Roumen, FJME, Scheepers, HCJ, de Boer, K, Duvekot, JJ, Thornton, JG, and Scherjon, SA
- Published
- 2007
34. Progesterone for the prevention of preterm birth in women with multiple pregnancies: the AMPHIA trial
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Lim, AC, Bloemenkamp, KWM, Boer, K, Duvekot, J.J., Erwich, JJHM, Hasaart, THM, Hummel, P, Mol, BWJ (Ben), Offermans, JPM, van Oirschot, CM, Anagnostou, I, Scheepers, HCJ, Schöls, WA, Vandenbussche, FPHA, Wouters, MGAJ, Bruinse, HW, Lim, AC, Bloemenkamp, KWM, Boer, K, Duvekot, J.J., Erwich, JJHM, Hasaart, THM, Hummel, P, Mol, BWJ (Ben), Offermans, JPM, van Oirschot, CM, Anagnostou, I, Scheepers, HCJ, Schöls, WA, Vandenbussche, FPHA, Wouters, MGAJ, and Bruinse, HW
- Published
- 2007
35. An economic analysis of immediate delivery and expectant monitoring in women with hypertensive disorders of pregnancy, between 34 and 37 weeks of gestation (HYPITAT-II).
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Baaren, G‐J, Broekhuijsen, K, Pampus, MG, Ganzevoort, W, Sikkema, JM, Woiski, MD, Oudijk, MA, Bloemenkamp, KWM, Scheepers, HCJ, Bremer, HA, Rijnders, RJP, Loon, AJ, Perquin, DAM, Sporken, JMJ, Papatsonis, DNM, Huizen, ME, Vredevoogd, CB, Brons, JTJ, Kaplan, M, and Kaam, AH
- Subjects
DELIVERY (Obstetrics) ,PREGNANCY complications ,COST effectiveness ,MEDICAL care costs ,RESPIRATORY distress syndrome ,HYPERTENSION in pregnancy ,MEDICAL care cost statistics ,COMPARATIVE studies ,GESTATIONAL age ,INDUCED labor (Obstetrics) ,RESEARCH methodology ,EVALUATION of medical care ,MEDICAL cooperation ,PREGNANCY ,RESEARCH ,EVALUATION research ,RANDOMIZED controlled trials ,THERAPEUTICS - Abstract
Objective: To assess the economic consequences of immediate delivery compared with expectant monitoring in women with preterm non-severe hypertensive disorders of pregnancy.Design: A cost-effectiveness analysis alongside a randomised controlled trial (HYPITAT-II).Setting: Obstetric departments of seven academic hospitals and 44 non-academic hospitals in the Netherlands.Population: Women diagnosed with non-severe hypertensive disorders of pregnancy between 340/7 and 370/7 weeks of gestation, randomly allocated to either immediate delivery or expectant monitoring.Methods: A trial-based cost-effectiveness analysis was performed from a healthcare perspective until final maternal and neonatal discharge.Main Outcome Measures: Health outcomes were expressed as the prevalence of respiratory distress syndrome, defined as the need for supplemental oxygen for >24 hours combined with radiographic findings typical for respiratory distress syndrome. Costs were estimated from a healthcare perspective until maternal and neonatal discharge.Results: The average costs of immediate delivery (n = 352) were €10 245 versus €9563 for expectant monitoring (n = 351), with an average difference of €682 (95% confidence interval, 95% CI -€618 to €2126). This 7% difference predominantly originated from the neonatal admissions, which were €5672 in the immediate delivery arm and €3929 in the expectant monitoring arm.Conclusion: In women with mild hypertensive disorders between 340/7 and 370/7 weeks of gestation, immediate delivery is more costly than expectant monitoring as a result of differences in neonatal admissions. These findings support expectant monitoring, as the clinical outcomes of the trial demonstrated that expectant monitoring reduced respiratory distress syndrome for a slightly increased risk of maternal complications.Tweetable Abstract: Expectant management in preterm hypertensive disorders is less costly compared with immediate delivery. [ABSTRACT FROM AUTHOR]- Published
- 2017
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36. Maintenance tocolysis with nifedipine in threatened preterm labour: 2-year follow up of the offspring in the APOSTEL II trial.
- Author
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Vliet, EOG, Seinen, L, Roos, C, Schuit, E, Scheepers, HCJ, Bloemenkamp, KWM, Duvekot, JJ, Eyck, J, Kok, JH, Lotgering, FK, Baar, A, Wassenaer‐Leemhuis, AG, Franssen, MT, Porath, MM, Post, JAM, Franx, A, Mol, BWJ, Oudijk, MA, van Vliet, Eog, and Duvekot, J J
- Subjects
NIFEDIPINE ,PREMATURE labor ,INFANT development ,DEVELOPMENTAL delay ,NEURODEVELOPMENTAL treatment for infants ,RANDOMIZED controlled trials ,THERAPEUTICS ,PREMATURE labor prevention ,PREVENTION of pregnancy complications ,TOCOLYTIC agents ,ANALYSIS of variance ,COMPARATIVE studies ,HUMAN reproductive technology ,LONGITUDINAL method ,RESEARCH methodology ,EVALUATION of medical care ,MEDICAL cooperation ,PREGNANCY ,SECOND trimester of pregnancy ,THIRD trimester of pregnancy ,QUESTIONNAIRES ,RESEARCH ,EVALUATION research ,BLIND experiment ,PRENATAL exposure delayed effects - Abstract
Objective: To evaluate long-term effects of maintenance tocolysis with nifedipine on neurodevelopmental outcome of the infant.Design, Setting and Population: Follow up of infants of women who participated in a multicentre randomised controlled trial on maintenance tocolysis with nifedipine versus placebo.Methods: Two years after the APOSTEL II trial on maintenance tocolysis with nifedipine versus placebo, we asked participants to complete the Ages and Stages Questionnaire.Main Outcome Measures: Infant development was measured in five domains. Developmental delay was defined as a score of ≤1 SD in one or more developmental domains. We performed exploratory subgroup analysis in women with preterm prolonged rupture of the membranes, and in women with a cervical length <10 mm at study entry.Results: Of the 276 women eligible for follow up, 135 (52.5%) returned the questionnaire, encompassing data of 170 infants. At 2 years of age, infants of women with nifedipine maintenance tocolysis compared with placebo had a higher overall incidence of fine motor problems (22.2 versus 7.6%, OR 3.43, 95% CI 1.29-9.14, P = 0.01), and a lower incidence of poor problem-solving (21.1 versus 29.1%, OR 0.27, 95% CI 0.08-0.95, P = 0.04).Conclusions: This follow-up study revealed no clear benefit of nifedipine maintenance tocolysis at 2 years of age. As short-term adverse perinatal outcome was not reduced in the original APOSTEL II trial, we conclude that maintenance tocolysis does not appear to be beneficial at this time.Tweetable Abstract: No clear benefit of nifedipine maintenance tocolysis in preterm labour on 2-year infant outcome. [ABSTRACT FROM AUTHOR]- Published
- 2016
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37. Routine labour epidural analgesia versus labour analgesia on request: a randomised non-inferiority trial.
- Author
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Wassen, MMLH, Smits, LJM, Scheepers, HCJ, Marcus, MAE, Van Neer, J, Nijhuis, JG, and Roumen, FJME
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EPIDURAL analgesia ,ANALGESIA ,PREGNANCY ,CONFIDENCE intervals ,CESAREAN section - Abstract
Objective To assess the effect on mode of delivery of the routine use of labour epidural analgesia ( EA) compared with analgesia on request. Design Randomised non-inferiority trial. Setting One university and one non-university teaching hospital in The Netherlands. Population Women with a singleton pregnancy in cephalic presentation beyond 36 + 0 weeks' gestation. Methods Participants were randomly allocated to receive either routine EA or analgesia on request. Intention-to-treat ( ITT) and per-protocol ( PP) analyses were performed, with confidence intervals ( CI) calculated for the differences in percentages or means. Main outcome measures Rate of operative delivery (instrumental vaginal or caesarean), labour characteristics, and adverse labour and neonatal outcomes. Results A total of 488 women were randomly allocated to the routine EA ( n = 233) or analgesia on request group ( n = 255). In the routine EA group, 89.3% (208/233) received EA. According to ITT analysis, 34.8% (81/233) women in the routine EA group had an operative delivery, compared with 26.7% (68/255) in the analgesia on request group (difference 8.1%, 95% CI −0.1 to 16.3). The difference in rate of operative deliveries according to the PP analysis was statistically significant (difference 8.9%, 95% CI 0.4 to 17.4). Inferiority of EA could not be rejected, as in both analyses the upper bound of the confidence interval exceeded the pre-specified inferiority criterion of +10%. Women in the routine EA group had more adverse effects, including hypotension (difference 9.5%, 95% CI 4.2 to 14.9), and motor blockade (difference 6.8%, 95% CI 1.1 to 12.5). Conclusion Non-inferiority of routine EA could not be demonstrated in this trial. Routine EA use is likely to lead to more operative deliveries and more maternal adverse effects. The results of our study do not justify routine use of EA. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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38. Involving women in personalised decision-making on mode of delivery after caesarean section: the development and pilot testing of a patient decision aid.
- Author
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Schoorel, ENC, Vankan, E, Scheepers, HCJ, Augustijn, BCC, Dirksen, CD, Koning, M, Kuijk, SMJ, Kwee, A, Melman, S, Nijhuis, JG, Aardenburg, R, Boer, K, Hasaart, THM, Mol, BWJ, Nieuwenhuijze, M, Pampus, MG, Roosmalen, J, Roumen, FJME, Vries, R, and Wouters, MGAJ
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VAGINAL birth after cesarean ,CESAREAN section prevention ,DECISION making ,PROBLEM solving ,VETERINARY obstetrics - Abstract
Objective To develop a patient decision aid (Pt DA) for mode of delivery after caesarean section that integrates personalised prediction of vaginal birth after caesarean ( VBAC) with the elicitation of patient preferences and evidence-based information. Design A Pt DA was developed and pilot tested using the International Patients Decision Aid Standards ( IPDAS) criteria. Setting Obstetric health care in the Netherlands. Population A multidisciplinary steering group, an expert panel, and 25 future users of the Pt DA, i.e. women with a previous caesarean section. Methods The development consisted of a construction phase (defini-tion of scope and purpose, and selection of content, framework, and format) and a pilot testing phase by interview. The process was supervised by a multidisciplinary steering group. Main outcome measures Usability, clarity, and relevance. Results The construction phase resulted in a booklet including unbiased balanced information on mode of birth after caesarean section, a preference elicitation exercise, and tailored risk information, including a prediction model for successful VBAC. During pilot testing, visualisation of risks and clarity formed the main basis for revisions. Pilot testing showed the availability of tailored structured information to be the main factor involving women in decision-making. The Pt DA meets 39 out of 50 IPDAS criteria (78%): 23 out of 23 criteria for content (100%) and 16 out of 20 criteria for the development process (80%). Criteria for effectiveness ( n = 7) were not evaluated. Conclusions An evidence-based Pt DA was developed, with the probability of successful VBAC and the availability of structured information as key items. It is likely that the Pt DA enhances the quality of decision-making on mode of birth after caesarean section. [ABSTRACT FROM AUTHOR]
- Published
- 2014
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39. Cost-effectiveness of induction of labour at term with a Foley catheter compared to vaginal prostaglandin E2 gel (PROBAAT trial)
- Author
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van Baaren, Gj, Jozwiak, M, Opmeer, Bc, Oude Rengerink, K, Benthem, M, Dijksterhuis, Mgk, van Huizen, Me, van der Salm, Pcm, Schuitemaker, Nwe, Papatsonis, Dnm, Perquin, Dam, Porath, M, van der Post, Jam, Rijnders, Rjp, Scheepers, Hcj, Spaanderman, M, van Pampus, Mg, de Leeuw, Jw, Mol, Bwj, and Bloemenkamp, Kwm
- Published
- 2013
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40. Cost-effectiveness of induction of labour at term with a Foley catheter compared to vaginal prostaglandin E2 gel ( PROBAAT trial).
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Baaren, GJ, Jozwiak, M, Opmeer, BC, Oude Rengerink, K, Benthem, M, Dijksterhuis, MGK, Huizen, ME, Salm, PCM, Schuitemaker, NWE, Papatsonis, DNM, Perquin, DAM, Porath, M, Post, JAM, Rijnders, RJP, Scheepers, HCJ, Spaanderman, M, Pampus, MG, Leeuw, JW, Mol, BWJ, and Bloemenkamp, KWM
- Subjects
COST effectiveness ,URINARY catheters ,PROSTAGLANDINS ,INDUCED labor (Obstetrics) ,INDUCED ovulation ,RANDOMIZED controlled trials - Abstract
Objective To assess the economic consequences of labour induction with Foley catheter compared to prostaglandin E
2 gel. Design Economic evaluation alongside a randomised controlled trial. Setting Obstetric departments of one university and 11 teaching hospitals in the Netherlands. Population Women scheduled for labour induction with a singleton pregnancy in cephalic presentation at term, intact membranes and an unfavourable cervix; and without previous caesarean section. Methods Cost-effectiveness analysis from a hospital perspective. Main outcome measures We estimated direct medical costs associated with healthcare utilisation from randomisation to 6 weeks postpartum. For caesarean section rate, and maternal and neonatal morbidity we calculated the incremental cost-effectiveness ratios, which represent the costs to prevent one of these adverse outcomes. Results Mean costs per woman in the Foley catheter group ( n = 411) and in the prostaglandin E2 gel group ( n = 408), were €3297 versus €3075, respectively, with an average difference of €222 (95% confidence interval −€157 to €633). In the Foley catheter group we observed higher costs due to longer labour ward occupation and less cost related to induction material and neonatal admissions. Foley catheter induction showed a comparable caesarean section rate compared with prostaglandin induction, therefore the incremental cost-effectiveness ratio was not informative. Foley induction resulted in fewer neonatal admissions (incremental cost-effectiveness ratio €2708) and asphyxia/postpartum haemorrhage (incremental cost-effectiveness ratios €5257) compared with prostaglandin induction. Conclusions Foley catheter and prostaglandin E2 labour induction generate comparable costs. [ABSTRACT FROM AUTHOR]- Published
- 2013
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41. Transfusion policy after severe postpartum haemorrhage: a randomised non-inferiority trial.
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Prick, Bw, Jansen, Ajg, Steegers, Eap, Hop, Wcj, Essink-Bot, Ml, Uyl-de Groot, Ca, Akerboom, Bmc, van Alphen, M, Bloemenkamp, Kwm, Boers, Ke, Bremer, Ha, Kwee, A, van Loon, Aj, Metz, Gch, Papatsonis, Dnm, van der Post, Jam, Porath, Mm, Rijnders, Rjp, Roumen, Fjme, and Scheepers, Hcj
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- 2007
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42. Eating and drinking in labor: the influence of caregiver advice on women's behavior.
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Scheepers HCJ, Thans MCJ, de Jong PA, Essed GGM, Le Cessie S, and Kanhai HHH
- Abstract
BACKGROUND: Although there is much debate about eating and drinking during labor, little scientific data about its influence on the course of labor exist. In The Netherlands, most midwives and obstetricians allow women to eat and drink during normal labor. The objective of this study was to examine whether or not women were actively advised to eat and drink and if this advice affected eating and drinking behavior. METHODS: A randomly selected group of midwives and obstetricians from across The Netherlands identified 211 consecutive nulliparous women to participate in the study. In a questionnaire with open-ended questions, women were asked after their delivery whether or not they were advised about eating and drinking during labor, and if so, about the nature of this advice and what they had consumed. Data were analyzed at the Leyenburg Hospital in The Hague. RESULTS: Sixty-six percent of the women were not given advice about eating and drinking during labor. Women who were given advice usually followed it. In the total group, 37 percent of the women had intake other than water and of these, 75 percent ate solid food. After adjusting for other prognostic factors, the incidence of an instrumental delivery due to a nonprogressing second stage was lower in women with caloric intake (13% vs 24%, p = 0.04). CONCLUSION: The study design did not enable us to draw conclusions about the cause and effect between caloric intake and labor progress. Scientific data with respect to the giving of evidence-based advice about eating and drinking during labor are lacking. Should such advice become available, women are likely to follow it. [ABSTRACT FROM AUTHOR]
- Published
- 2001
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43. Birth spacing and adverse perinatal outcomes.
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Scheepers HCJ, Braat D, Conde-Agudelo A, Rosas-Bermudez A, Kafury-Goeta AC, Scheepers, H C J, and Braat, Didi
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- 2006
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44. Optimization of the betamethasone and dexamethasone dosing regimen during pregnancy: a combined placenta perfusion and pregnancy physiologically based pharmacokinetic modeling approach.
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Van Der Heijden JEM, Van Hove H, Van Elst NM, Van Den Broek P, Van Drongelen J, Scheepers HCJ, De Wildt SN, and Greupink R
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- Female, Pregnancy, Humans, Perfusion, Maternal-Fetal Exchange, Respiratory Distress Syndrome, Newborn prevention & control, Fetus drug effects, Fetus metabolism, Betamethasone pharmacokinetics, Betamethasone administration & dosage, Dexamethasone pharmacokinetics, Dexamethasone administration & dosage, Placenta metabolism, Glucocorticoids pharmacokinetics, Glucocorticoids administration & dosage, Models, Biological
- Abstract
Background: Antenatal betamethasone and dexamethasone are prescribed to women who are at high risk of premature birth to prevent neonatal respiratory distress syndrome (RDS). The current treatment regimens, effective to prevent neonatal RDS, may be suboptimal. Recently, concerns have been raised regarding possible adverse long-term neurological outcomes due to high fetal drug exposures. Data from nonhuman primates and sheep suggest maintaining a fetal plasma concentration above 1 ng/mL for 48 hours to retain efficacy, while avoiding undesirable high fetal plasma levels., Objective: We aimed to re-evaluate the current betamethasone and dexamethasone dosing strategies to assess estimated fetal exposure and provide new dosing proposals that meet the efficacy target but avoid excessive peak exposures., Study Design: A pregnancy physiologically based pharmacokinetic (PBPK) model was used to predict fetal drug exposures. To allow prediction of the extent of betamethasone and dexamethasone exposure in the fetus, placenta perfusion experiments were conducted to determine placental transfer. Placental transfer rates were integrated in the PBPK model to predict fetal exposure and model performance was verified using published maternal and fetal pharmacokinetic data. The verified pregnancy PBPK models were then used to simulate alternative dosing regimens to establish a model-informed dose., Results: Ex vivo data showed that both drugs extensively cross the placenta. For betamethasone 15.7±1.7% and for dexamethasone 14.4±1.5%, the initial maternal perfusate concentration reached the fetal circulations at the end of the 3-hour perfusion period. Pregnancy PBPK models that include these ex vivo-derived placental transfer rates accurately predicted maternal and fetal exposures resulting from current dosing regimens. The dose simulations suggest that for betamethasone intramuscular, a dose reduction from 2 dosages 11.4 mg, 24 hours apart, to 4 dosages 1.425 mg, 12 hours apart would avoid excessive peak exposures and still meet the fetal response threshold. For dexamethasone, the dose may be reduced from 4 times 6 mg every 12 hours to 8 times 1.5 mg every 6 hours., Conclusion: A combined placenta perfusion and pregnancy PBPK modeling approach adequately predicted both maternal and fetal drug exposures of 2 antenatal corticosteroids (ACSs). Strikingly, our PBPK simulations suggest that drug doses might be reduced drastically to still meet earlier proposed efficacy targets and minimize peak exposures. We propose the provided model-informed dosing regimens are used to support further discussion on an updated ACS scheme and design of clinical trials to confirm the effectiveness and safety of lower doses., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
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- 2025
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45. Barriers and facilitators for adequate calcium intake during pregnancy: A mixed methods study.
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Mesters I, Willemse JPMM, van Montfort P, Meertens LJE, Kruitwagen J, Smits LJM, and Scheepers HCJ
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Objective: This study evaluates the effectiveness of calcium supplementation as a preventive measure for pregnant women with insufficient calcium intake, examining adherence to the recommended 1000 mg daily intake and identifying influencing factors., Methods: A survey (Expect cohort II, n = 823) evaluated calcium adherence among pregnant women, followed by interviews with sixteen purposefully selected participants. Verbatim transcripts were independently analyzed to identify key themes., Results: Among survey participants, 82 % discussed the importance of calcium intake, with 83 % expressing intent to improve intake. Of those counselled on calcium, 48 % had insufficient intake, compared to 64 % without counseling. Facilitators included perceived safety, maternal motivation to keep child safe, trust in professionals, supportive environments, and increased awareness. Obstacles included lack of knowledge on calcium sources, pill dosage, low intrinsic motivation, information comprehension and novelty of the advice., Conclusion: Despite of awareness raising efforts through counseling, only half of the women reached adequate calcium levels, with interviews revealing limited understanding. Clear messages on calcium benefits, dispelling concerns about potential harm, and offering concrete guidance can improve intake. Repetition of advice and increase publicity can normalize and enhance acceptability of calcium consumption during pregnancy., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)
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- 2025
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46. A User-Driven Framework for Dose Selection in Pregnancy: Proof of Concept for Sertraline.
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Koldeweij C, Dibbets C, Franklin BD, Scheepers HCJ, and de Wildt SN
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- Humans, Pregnancy, Female, Pregnancy Complications drug therapy, Pilot Projects, Proof of Concept Study, Dose-Response Relationship, Drug, Selective Serotonin Reuptake Inhibitors pharmacokinetics, Selective Serotonin Reuptake Inhibitors administration & dosage, Selective Serotonin Reuptake Inhibitors adverse effects, Risk Assessment, Anxiety Disorders drug therapy, Antidepressive Agents administration & dosage, Antidepressive Agents pharmacokinetics, Antidepressive Agents adverse effects, Sertraline administration & dosage, Sertraline pharmacokinetics, Sertraline adverse effects
- Abstract
Despite growing knowledge of pregnancy-induced changes in physiology that may alter maternal and fetal pharmacokinetics, evidence-based antenatal doses are lacking for most drugs. Pharmacokinetic modeling and expanding clinical data in pregnancy may support antenatal doses. We aimed to develop and pilot a comprehensive and user-driven Framework for Dose Selection in Pregnancy to support the clinical implementation of a best-evidence antenatal dose for sertraline. After initial development and evaluation by experts, the framework prototype was piloted to formulate an antenatal dosing strategy for sertraline in depression and anxiety disorders. Next, the framework was reviewed and assessed for usability by a multidisciplinary working committee of end-users comprising healthcare practitioners, experts from other disciplines including pharmacometrics, reproductive toxicology and medical ethics, alongside pregnant women and a partner. The resulting framework encompasses the following: rationale for drug selection, a comprehensive analysis of pharmacokinetic and dose-related efficacy and safety data, and implementation aspects including feasibility and desirability of the recommended antenatal dose based on a structured maternal and fetal benefit-risk assessment. An antenatal dose recommendation for sertraline, as a case study, was formulated using this approach and endorsed for clinical use by the working committee. Future applications of the framework for other drugs can further demonstrate its suitability for developing best evidence, acceptable and clinically feasible antenatal doses., (© 2024 The Author(s). Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)
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- 2025
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47. Barriers and Facilitators for Bringing Model-Informed Precision Dosing to the Patient's Bedside: A Systematic Review.
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Dibbets AC, Koldeweij C, Osinga EP, Scheepers HCJ, and de Wildt SN
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Model-informed precision dosing (MIPD) utilizes mathematical models to predict optimal medication doses for a specific patient or patient population. However, the factors influencing the implementation of MIPD have not been fully elucidated, hindering its widespread use in clinical practice. A systematic review was conducted in PubMed from inception to December 2022, aiming to identify barriers and facilitators for the implementation of MIPD into patient care. Articles with a focus on implementation of MIPD were eligible for this review. After screening titles and abstracts, full articles investigating the clinical implementation of MIPD were included for data extraction. Of 790 records identified, 15 publications were included. A total of 72 barriers and facilitators across seven categories were extracted through a hybrid thematic analysis. Barriers comprised limited data for model validation, unclear regulatory pathways for model endorsement and additional drug level measurements required for certain types of MIPD. Facilitators encompassed the development of user-friendly MIPD tools continuously updated based on user feedback and data. Collaborative efforts among diverse stakeholders for model validation and implementation, along with education of end-users, may promote the utilization of MIPD in patient care. Despite ongoing challenges, this systematic review revealed various strategies to facilitate the clinical implementation of MIPD., (© 2024 The Author(s). Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)
- Published
- 2024
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48. Validation of the Birth Beliefs Scale for maternity care professionals in The Netherlands.
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Zondag DC, van Haaren-Ten Haken TM, Offerhaus PM, Mestdagh E, Scheepers HCJ, and Nieuwenhuijze MJ
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- Humans, Female, Adult, Netherlands, Reproducibility of Results, Surveys and Questionnaires standards, Psychometrics instrumentation, Psychometrics standards, Parturition psychology, Pregnancy, Male, Health Personnel psychology, Maternal Health Services standards, Health Knowledge, Attitudes, Practice, Middle Aged, Attitude of Health Personnel
- Abstract
Objectives: To validate the Birth Beliefs Scale (BBS) for maternity care professionals by testing: (1) content validity; (2) internal reliability; (3) known-group discriminant validity; and examine potential relationships between regions and birth beliefs., Methods: First, content validity was tested. Before distribution of the questionnaire among maternity care professionals of six maternity care networks (MCNs), adjustments in the statements were made whenever content validity was too low. Data were collected from November 2022 to March 2023. Statistical analysis was performed using Cronbach's alpha, ANOVA and regression analysis., Results: Based on the content validity-test, item 6 of the questionnaire was adjusted before distribution. In total, 199 maternity care professionals completed the questionnaire. A good internal reliability of the BBS was found. There was a significant difference between the different disciplines for the BBS-Med subscale ( p < .001), and the BBS-Nat subscale ( p < .001). For the BBS-Nat subscale, the factors work experience and MCN were significant in the regression analysis, with interaction on the association between BBS-Nat and discipline., Conclusions: The BBS is a valid instrument to measure birth beliefs among maternity care professionals. The BBS can help to create awareness within professionals of their beliefs and may help to explain practice variation in childbirth.
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- 2024
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49. Current predictors for morbidity regarding choice of birth after a previous caesarean section, show poor predictive value in prediction modelling.
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van Hees MSF, van Kuijk SMJ, Koppes DM, Oudijk MA, Vankan E, Smits LJ, and Scheepers HCJ
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- Humans, Female, Pregnancy, Adult, Netherlands epidemiology, Cohort Studies, Postpartum Hemorrhage epidemiology, Postpartum Hemorrhage etiology, Infant, Newborn, Morbidity, Vaginal Birth after Cesarean statistics & numerical data, Trial of Labor, Cesarean Section, Repeat statistics & numerical data
- Abstract
Introduction: After a previous caesarean section, morbidity in the subsequent delivery in general is considered to depend on the probability of a vaginal birth after caesarean. However counselling could be improved by adding individualized probability of serious morbidity following either trial of labour or elective repeat caesarean section. The objective of this study was to develop prediction models for morbidity for both a repeat caesarean section and a trial of labor for a Dutch population., Material and Methods: In this cohort study, data were joined from three previous studies (SIMPLE 1, SIMPLE 2 and SIMPLE 2-implementation study). A cohort of 2592 women with one previous caesarean section and a singleton pregnancy who delivered ≥37 weeks, without a contraindication for vaginal delivery was formed. Maternal morbidity was defined as postpartum hemorrhage, blood transfusion, uterine rupture, ICU admittance or death. Neonatal morbidity was defined as asphyxia, NICU-admittance or death. Potential predictors for morbidity were chosen based on literature and expert opinion. Logistic regression was used to develop the models. Internal validation was intended using bootstrapping techniques. Main outcome measures were predictors for morbidity and for validation of the model we used the area under the receiver operating characteristic curve for discriminative capacity and calibration for accuracy., Results: In 324 out of the 2592 cases (12.7 %) maternal or fetal complications occurred. In general total morbidity was higher in women choosing TOL as compared to ERCS (p < 0.001). The performance of the several developed models was insufficient, the area under the receiver operating characteristic curve did not rise above 0.6. Due to poor model performance, before correction for overfitting, interval validation was not conducted., Conclusion: In this large cohort, developing a Dutch population based prediction model that aimed to improve counselling on the mode of delivery, by predicting individual chances of morbidity for different delivery modes was not possible, due to lack of performance. Further study could be directed to cut off on VBAC success rates to a more general advice regarding the safest mode of delivery., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier B.V.)
- Published
- 2024
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50. Cost-effectiveness of a randomized controlled trial comparing low-dose aspirin to placebo for the prevention of recurrent preterm birth.
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Landman AJEMC, Broulikova HM, Visser L, Nijman TAJ, Hemels MAC, Vollebregt KC, Boormans EMA, Bremer HA, Tuinman E, Langenveld J, van der Made F, Rijnders RJP, van Vliet HAAM, Freeman LM, de Heus R, Blaauw J, Krabbendam I, van de Laar R, Verberg MFG, Scheepers HCJ, Mol BW, de Groot CJM, Oudijk MA, Bosmans JE, and de Boer MA
- Abstract
To assess the cost-effectiveness of low-dose aspirin compared to placebo for the prevention of recurrent preterm birth from a healthcare perspective. This was a cost-effectiveness analysis alongside a multicenter, randomized, double-blinded, placebo-controlled trial. We included women with a singleton pregnancy and a previous spontaneous preterm birth <37 weeks of gestation of a singleton. Women were randomized between aspirin 80 mg daily and placebo, initiated between 8 and 16 weeks of gestation. We estimated the difference in preterm births (<37 weeks of gestation), and maternal and neonatal healthcare costs using seemingly unrelated linear regression analyses. Bootstrapping was performed to estimate statistical uncertainty. A total of 387 women were included: 194 in the aspirin group and 193 in the placebo group. We observed a small, statistically non-significant difference in preterm birth (21.2% vs. 25.4%; risk difference -4.3%; 95% CI: -12.7% to 4.1%) and healthcare costs (mean -€99; 95% CI: -€2385 to €2325) in the aspirin group compared to placebo. The cost-effectiveness acceptability curve showed that the probability of aspirin being cost-effective was 54% for a willingness to pay threshold of €0 for one prevented preterm birth and 78% for €50 000 for one prevented preterm birth. Our findings suggest that aspirin is the dominant strategy over placebo for the prevention of preterm birth. However, there was substantial uncertainty around the results and definite conclusions regarding the cost-effectiveness of aspirin cannot be drawn., (© 2024 The Author(s). International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)
- Published
- 2024
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