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1. Induction of labor with Foley catheter and risk of subsequent preterm birth: follow-up study of two randomized controlled trials (PROBAAT-1 and -2)

Author

de Vaan, M.D.T. (M. D.T.), Blel, D. (D.), Bloemenkamp, K.W.M. (Kitty), Jozwiak, M. (Marta), ten Eikelder, M.L.G. (Mieke L.G.), de Leeuw, J.W. (J. W.), Oudijk, M.A. (Martijn), Bakker, J.J.H. (J. J.H.), Rijnders, R.J.P. (Robbert), Papatsonis, D.N.M. (Dimitri), Woiski, M.D. (Mallory), Mol, B.W.J. (Ben), Heus, R. (Roel) de, de Vaan, M.D.T. (M. D.T.), Blel, D. (D.), Bloemenkamp, K.W.M. (Kitty), Jozwiak, M. (Marta), ten Eikelder, M.L.G. (Mieke L.G.), de Leeuw, J.W. (J. W.), Oudijk, M.A. (Martijn), Bakker, J.J.H. (J. J.H.), Rijnders, R.J.P. (Robbert), Papatsonis, D.N.M. (Dimitri), Woiski, M.D. (Mallory), Mol, B.W.J. (Ben), and Heus, R. (Roel) de

Abstract

Objective: To evaluate the rate of preterm birth (PTB) in a subsequent pregnancy in women who had undergone term induction using a Foley catheter compared with prostaglandins. Methods: This was a follow-up study of two large randomized controlled trials (PROBAAT-1 and PROBAAT-2). In the original trials, women with a term singleton pregnancy with the fetus in cephalic presentation and with an indication for labor induction were randomized to receive either a 30-mL Foley catheter or prostaglandins (vaginal prostaglandin E2 in PROBAAT-1 and oral misoprostol in PROBAAT-2). Data on subsequent ongoing pregnancies > 16 weeks’ gestation were collected from hospital charts from clinics participating in this follow-up study. The main outcome measure was preterm birth < 37 weeks’ gestation in a subsequent pregnancy. Results: Fourteen hospitals agreed to participate in this follow-up study. Of the 1142 eligible women, 572 had been allocated to induction of labor using a Foley catheter and 570 to induction of labor using prostaglandins. Of these, 162 (14%) were lost to follow-up. In total, 251 and 258 women had a known subsequent pregnancy > 16 weeks' gestation in the Foley catheter and prostaglandin groups, respectively. There were no differences in baseline characteristics between the groups. The overall rate of PTB in a subsequent pregnancy was 9/251 (3.6%) in the Foley catheter group vs 10/258 (3.9%) in the prostaglandin group (relative risk (RR), 0.93; 95% CI, 0.38–2.24), and the rate of spontaneous PTB was 5/251 (2.0%) vs 5/258 (1.9%) (RR, 1.03; 95% CI, 0.30–3.51). Conclusion: In women with term singleton pregnancy, induction of labor using a 30-mL Foley catheter is not associated with an increased risk of PTB in a subsequent pregnancy, as compared to induction of labor using prostaglandins.

Published
2020
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2. Clinical characteristics of women captured by extending the definition of severe postpartum haemorrhage with 'refractoriness to treatment': a cohort study

Author

Henriquez, D., Gillissen, A., Smith, S.M., Cramer, R.A., van den Akker, T., Zwart, J.J. (Joost), van Roosmalen, J.J., Bloemenkamp, KW, Bom, J.G., Adriaanse, H.J., van den Akker, E.S.A., Baas, M.I., Bank, C.M.C., Beek, E. van, de Boer, B.A.G., Boer, K. (Karin), van der Borden, D.M.R., Bremer, H.A. (Henk), Brons, J.T.J., Burggraaff, J.M. (Jan), Ceelie, H., Chon, H., Cikot, J.L.M., Delemarre, F.M.C., Diris, J.H.C., Doesburg-van Kleffens, M., van Dooren, I.M.A., van Duijnhoven, J.L.P., van Dunn, F.M., Duvekot, J.J. (Hans), Engbers, P., van Hulst, M.J.W., Feitsma, H., Fouraux, M.A., Franssen, MT, Frasa, M.A.M., van Gammeren, A.J., Gemund, N. (Nicolette) van, van der Graaf, F., Groot, C.J.M., Hackeng, C.M. (Christian), Ham, D.P. (David) van der, Hanssen, M., Hasaart, T.H.M. (Tom), Hendriks, H.A., Henskens, Y.M.C., Hermsen, B.B.J., Hogenboom, S., Hooker, A., Hudig, F, Huijssoon, A.G. (Annemarie), Huisjes, A.J.M. (Anjoke), Jonker, N., Kabel, P.J., van Kampen, C., de Keijzer, M.H., van de Kerkhof, D.H., Keuren, JFW, Kleiverda, G., Klinkspoor, J.H., Koehorst, S.G.A., Kok, M.O. (Maarten), Kok, R.D., Kok, J.B. (Jacques) de, Koops, A., Kortlandt, W. (Wouter), Langenveld, J. (J.), Leers, MPG, Leyte, A. (Anja), de Mare, A., Martens, G.D.M., Meekers, J.H., Meir, C.A. (Claudia) van, Metz, G.C.H. (Godfried), Michielse, E., Mostert, L.J., Bijvank, S., Oostenveld, E., Osmanovic, N., Oudijk, M.A. (Martijn), Mirani-Oostdijk, C.P., van Pampus, E. C. M., Papatsonis, D.N.M. (Dimitri), Peters, R.H.M., Ponjee, G.A.E. (Gabriëlle), Pontesilli, M., Porath, M. (Martina), Post, M.S., Pouwels, J.G.J., Prinzen, L., Roelofsen, J.M.T., Rondeel, J.J.M., Salm, P.C.M. (Paulien) van der, Scheepers, H.C.J. (Hubertina), Schippers, D.H. (Daniela), Schuitemaker, N.W.E. (Nico), Sikkema, J.M. (J. Marko), Slomp, J. (Jennita), Smit, J.W.A. (Jan), Snuif-de Lange, Y.S., van der Stappen, J.W.J., Steures, P. (Pieternel), Tax, G.H.M., Treskes, M., Ulenkate, H., van Unnik, G.A., van der Veen, B.S., Verhagen, T.E.M., Versendaal, J. (Johan), Visschers, B., Visser, O. (Oane), de Visser, H., De Vooght, KMK, de Vries, M.J., Waard, H. (Harm) de, Weerkamp, F. (Floor), Weinans, M.J.N. (Martin), de Wet, H., Wijnen, M. (Marit), Wijngaarden, W.J. (Wim) van, de Wit, A.C., Woiski, M.D. (Mallory), TeMp, O.H.S.G., Henriquez, D., Gillissen, A., Smith, S.M., Cramer, R.A., van den Akker, T., Zwart, J.J. (Joost), van Roosmalen, J.J., Bloemenkamp, KW, Bom, J.G., Adriaanse, H.J., van den Akker, E.S.A., Baas, M.I., Bank, C.M.C., Beek, E. van, de Boer, B.A.G., Boer, K. (Karin), van der Borden, D.M.R., Bremer, H.A. (Henk), Brons, J.T.J., Burggraaff, J.M. (Jan), Ceelie, H., Chon, H., Cikot, J.L.M., Delemarre, F.M.C., Diris, J.H.C., Doesburg-van Kleffens, M., van Dooren, I.M.A., van Duijnhoven, J.L.P., van Dunn, F.M., Duvekot, J.J. (Hans), Engbers, P., van Hulst, M.J.W., Feitsma, H., Fouraux, M.A., Franssen, MT, Frasa, M.A.M., van Gammeren, A.J., Gemund, N. (Nicolette) van, van der Graaf, F., Groot, C.J.M., Hackeng, C.M. (Christian), Ham, D.P. (David) van der, Hanssen, M., Hasaart, T.H.M. (Tom), Hendriks, H.A., Henskens, Y.M.C., Hermsen, B.B.J., Hogenboom, S., Hooker, A., Hudig, F, Huijssoon, A.G. (Annemarie), Huisjes, A.J.M. (Anjoke), Jonker, N., Kabel, P.J., van Kampen, C., de Keijzer, M.H., van de Kerkhof, D.H., Keuren, JFW, Kleiverda, G., Klinkspoor, J.H., Koehorst, S.G.A., Kok, M.O. (Maarten), Kok, R.D., Kok, J.B. (Jacques) de, Koops, A., Kortlandt, W. (Wouter), Langenveld, J. (J.), Leers, MPG, Leyte, A. (Anja), de Mare, A., Martens, G.D.M., Meekers, J.H., Meir, C.A. (Claudia) van, Metz, G.C.H. (Godfried), Michielse, E., Mostert, L.J., Bijvank, S., Oostenveld, E., Osmanovic, N., Oudijk, M.A. (Martijn), Mirani-Oostdijk, C.P., van Pampus, E. C. M., Papatsonis, D.N.M. (Dimitri), Peters, R.H.M., Ponjee, G.A.E. (Gabriëlle), Pontesilli, M., Porath, M. (Martina), Post, M.S., Pouwels, J.G.J., Prinzen, L., Roelofsen, J.M.T., Rondeel, J.J.M., Salm, P.C.M. (Paulien) van der, Scheepers, H.C.J. (Hubertina), Schippers, D.H. (Daniela), Schuitemaker, N.W.E. (Nico), Sikkema, J.M. (J. Marko), Slomp, J. (Jennita), Smit, J.W.A. (Jan), Snuif-de Lange, Y.S., van der Stappen, J.W.J., Steures, P. (Pieternel), Tax, G.H.M., Treskes, M., Ulenkate, H., van Unnik, G.A., van der Veen, B.S., Verhagen, T.E.M., Versendaal, J. (Johan), Visschers, B., Visser, O. (Oane), de Visser, H., De Vooght, KMK, de Vries, M.J., Waard, H. (Harm) de, Weerkamp, F. (Floor), Weinans, M.J.N. (Martin), de Wet, H., Wijnen, M. (Marit), Wijngaarden, W.J. (Wim) van, de Wit, A.C., Woiski, M.D. (Mallory), and TeMp, O.H.S.G.

Abstract

Background: The absence of a uniform and clinically relevant definition of severe postpartum haemorrhage hampers comparative studies and optimization of clinical management. The concept of persistent postpartum haemorrhage, based on refractoriness to initial first-line treatment, was proposed as an alternative to common definitions that are either based on estimations of blood loss or transfused units of packed red blood cells (RBC). We compared characteristics and outcomes of women with severe postpartum haemorrhage captured by these three types of definitions. Methods: In this large retrospective cohort study in 61 hospitals in the Netherlands we included 1391 consecutive women with postpartum haemorrhage who received either ≥4 units of RBC or a multicomponent transfusion. Clinical characteristics and outcomes of women with severe postpartum haemorrhage defined as persistent postpartum haemorrhage were compared to definitions based on estimated blood loss or transfused units of RBC within 24 h following birth. Adverse maternal outcome was a composite of maternal mortality, hysterectomy, arterial embolisation and intensive care unit admission. Results: One thousand two hundred sixty out of 1391 women (90.6%) with postpartum haemorrhage fulfilled the definition of persistent postpartum haemorrhage. The majority, 820/1260 (65.1%), fulfilled this definition within 1 h following birth, compared to 819/1391 (58.7%) applying the definition of ≥1 L blood loss and 37/845 (4.4%) applying the definition of ≥4 units of RBC. The definition persistent postpartum haemorrhage captured 430/471 adverse maternal outcomes (91.3%), compared to 471/471 (100%) for ≥1 L blood loss and 383/471 (81.3%) for ≥4 units of RBC. Persiste

Published
2019
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3. Placental studies elucidate discrepancies between NIPT showing a structural chromosome aberration and a differently abnormal fetal karyotype

Author

Van Opstal, A.R.M. (Diane), van Veen, S. (Stefanie), Joosten, A-M.S (Marieke), Diderich, K.E.M. (Karin), Govaerts, L.C. (Lutgarde), Polak, J. (Joke), van Koetsveld, N. (Nicole), Boter, M. (Marjan), Go, A.T.J.I. (Attie), Papatsonis, D.N.M. (Dimitri), Prinsen, K. (Krista), Hoefsloot, E.H. (Lies), Srebniak, M.I. (Malgorzata), Van Opstal, A.R.M. (Diane), van Veen, S. (Stefanie), Joosten, A-M.S (Marieke), Diderich, K.E.M. (Karin), Govaerts, L.C. (Lutgarde), Polak, J. (Joke), van Koetsveld, N. (Nicole), Boter, M. (Marjan), Go, A.T.J.I. (Attie), Papatsonis, D.N.M. (Dimitri), Prinsen, K. (Krista), Hoefsloot, E.H. (Lies), and Srebniak, M.I. (Malgorzata)

Abstract

Objective: Placental cytogenetic studies may reveal the origin of discordant noninvasive prenatal testing (NIPT). We performed placental studies to elucidate discordances between NIPT showing a structural chromosome aberration and the fetus having a different chromosome aberration in three cases. Method: Diagnostic testing with genomic SNP microarray was performed in three cases with NIPT showing a duplication on 4q (case 1), a terminal deletion of 13q (case 2), and a terminal deletion of 15q (case 3). Placental studies involved SNP array analysis of cytotrophoblast and mesenchymal core of chorionic villi of four placental quadrants. Clinical follow-up was performed as well. Results: Amniotic fluid revealed a different structural chromosome aberration than predicted by NIPT: a terminal 2q deletion (case 1), a segmental uniparental isodisomy of 13q (case 2), and a terminal duplication of 15q and of 13q (case 3). Placental studies revealed the aberration detected with NIPT in the cytotrophoblast, whereas the fetal karyotype was confirmed in the placental mesenchymal core. Conclusion: Our study shows that targeted cytogenetic investigations for confirmation of NIPT showing a microscopically visible structural chromosome aberration should be avoided, since another aberration, even a submicroscopic one or one involving another chromosome, may be present in the fetus.

Published
2019
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4. Unexpected finding of uniparental disomy mosaicism in term placentas: Is it a common feature in trisomic placentas?

Author

Van Opstal, A.R.M. (Diane), Diderich, K.E.M. (Karin), Joosten, A-M.S (Marieke), Govaerts, L.C. (Lutgarde), Polak, J. (Joke), Boter, M. (Marjan), Saris, J.J. (Jasper J.), Cheung, W.Y. (Wai Yee), van Veen, S. (Stefanie), van de Helm, R. (Robert), Go, A.T.J.I. (Attie), Knapen, M.F.C.M. (Maarten), Papatsonis, D.N.M. (Dimitri), Dijkman, A., Vries, F.A.T. (Femke) de, Galjaard, R-J.H. (Robert-Jan), Hoefsloot, E.H. (Lies), Srebniak, M.I. (Malgorzata), Van Opstal, A.R.M. (Diane), Diderich, K.E.M. (Karin), Joosten, A-M.S (Marieke), Govaerts, L.C. (Lutgarde), Polak, J. (Joke), Boter, M. (Marjan), Saris, J.J. (Jasper J.), Cheung, W.Y. (Wai Yee), van Veen, S. (Stefanie), van de Helm, R. (Robert), Go, A.T.J.I. (Attie), Knapen, M.F.C.M. (Maarten), Papatsonis, D.N.M. (Dimitri), Dijkman, A., Vries, F.A.T. (Femke) de, Galjaard, R-J.H. (Robert-Jan), Hoefsloot, E.H. (Lies), and Srebniak, M.I. (Malgorzata)

Abstract

Objective: Non-invasive prenatal testing (NIPT) detects placental chromosome aberrations. When amniocentesis reveals a normal karyotype, confined placental mosaicism (CPM) may be assumed. In order to confirm this, placental cytogenetic studies were performed. Method: NIPT was conducted in the course of the Dutch TRIDENT study. Placentas of 10 cases with NIPT results indicating an autosomal trisomy and showing a normal (N = 9) or low mosaic karyotype (N = 1) in amniotic fluid (AF) were investigated. The cytotrophoblast as well as the mesenchymal core of two to four placental chorionic villi biopsies were studied with single nucleotide polymorphism (SNP) array. Clinical outcome data were collected. Results: In 10/10 cases, CPM was proven. In 3/10 cases trisomy/uniparental disomy (UPD)/biparental disomy (BPD) mosaicism was discovered. In 2/3 cases, all three cell lines were present in the placenta, whereas BPD was found in AF. In 1/3 cases trisomy 22/UPD22 was present in AF while trisomy 22/BPD22 mosaicism was found in the placenta. Five of 10 pregnancies were affected with pre-eclampsia, low birth weight, preterm delivery, and/or congenital malformations. Conclusion: The presence of trisomy/UPD/BPD mosaicism in 3/10 cases that we investigated proves that trisomic zygote rescue may involve multiple rescue events during early embryogenesis. UPD mosaicism, when present in crucial fetal tissues, may explain the abnormal phenotype in undiagnosed cases.

Published
2018
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5. Early enteral tube feeding in optimizing treatment of hyperemesis gravidarum: The Maternal and Offspring outcomes after Treatment of HyperEmesis by Refeeding (MOTHER) randomized controlled trial

Author

Grooten, I.J. (Iris J.), Koot, M.H. (Marjette H.), Post, J.A.M. (Joris) van der, Bais, A.G. (Aagje), Ris-stalpers, C. (Carrie), Naaktgeboren, C. (Christiana), Bremer, H.A. (Henk), Ham, D.P. (David) van der, Heidema, W.M. (Wieteke M.), Huisjes, A. (Anjoke), Kleiverda, G. (Gunilla), Kuppens, A.H. (An), Van Laar, J.O.E.H. (Judith O.E.H.), Langenveld, J. (Josje), Van Der Made, F. (Flip), Pampus, M. (Mariëlle) van, Papatsonis, D.N.M. (Dimitri), Pelinck, M.-J. (Marie-José), Pernet, P.J.M. (Paula), Van Rheenen, L. (Leonie), Rijnders, R.J.P. (Robbert), Scheepers, H.C.J. (Hubertina), Vogelvang, T.E. (Tatjana E.), Mol, B.W.J. (Ben), Roseboom, T.J. (Tessa), Painter, R.C. (Rebecca C.), Grooten, I.J. (Iris J.), Koot, M.H. (Marjette H.), Post, J.A.M. (Joris) van der, Bais, A.G. (Aagje), Ris-stalpers, C. (Carrie), Naaktgeboren, C. (Christiana), Bremer, H.A. (Henk), Ham, D.P. (David) van der, Heidema, W.M. (Wieteke M.), Huisjes, A. (Anjoke), Kleiverda, G. (Gunilla), Kuppens, A.H. (An), Van Laar, J.O.E.H. (Judith O.E.H.), Langenveld, J. (Josje), Van Der Made, F. (Flip), Pampus, M. (Mariëlle) van, Papatsonis, D.N.M. (Dimitri), Pelinck, M.-J. (Marie-José), Pernet, P.J.M. (Paula), Van Rheenen, L. (Leonie), Rijnders, R.J.P. (Robbert), Scheepers, H.C.J. (Hubertina), Vogelvang, T.E. (Tatjana E.), Mol, B.W.J. (Ben), Roseboom, T.J. (Tessa), and Painter, R.C. (Rebecca C.)

Abstract

Background: Hyperemesis gravidarum (HG) leads to dehydration, poor nutritional intake, and weight loss. HG has been associated with adverse pregnancy outcomes such as low birth weight. Information about the potential effectiveness of treatments for HG is limited. Objective: We hypothesized that in women with HG, early enteral tube feeding in addition to standard care improves birth weight. Design: We performed a multicenter, open-label randomized controlled trial [Maternal and Offspring outcomes after Treatment of HyperEmesis by Refeeding (MOTHER)] in 19 hospitals in the Netherlands. A total of 116 women hospitalized for HG between 5 and 20 wk of gestation were randomly allocated to enteral tube feeding for ≥7 d in addition to standard care with intravenous rehydration and antiemetic treatment or to standard care alone. Women were encouraged to continue tube feeding at home. On the basis of our power calculation, a sample size of 120 women was anticipated. Analyses were performed according to the intention-to-treat principle. Results: Between October 2014 and March 2016 we randomly allocated 59 women to enteral tube feeding and 57 women to standard care. The mean ± SD birth weight was 3160 ± 770 g in the enteral tube feeding group compared with 3200 ± 680 g in the standard care group (mean difference: -40 g, 95% CI: -230, 310 g). Secondary outcomes, including maternal weight gain, duration of hospital stay, readmission rate, nausea and vomiting symptoms, decrease in quality of life, psychological distress, prematurity, and small-for-gestationalage, also were comparable. Of the women allocated to enteral tube feeding, 28 (47%) were treated according to protocol. Enteral tube feeding was discontinued within 7 d of placement in the remaining women, primarily because of its adverse effects (34%). Conclusions: In women with HG, early enteral tube feeding does not improve birth weight or secondary outcomes. Many women discontinued tube feeding because of discomfort, sugge

Published
2017
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6. Prenatal diagnosis of susceptibility loci for neurodevelopmental disorders - genetic counseling and pregnancy outcome in 57 cases

Author

Govaerts, L.C. (Lutgarde), Srebniak, M.I. (Malgorzata), Diderich, K.E.M. (Karin), Joosten, A-M.S (Marieke), Riedijk, S.R. (Samantha), Knapen, M.F.C.M. (Maarten), Go, A.T.J.I. (Attie), Papatsonis, D.N.M. (Dimitri), de Graaf, K. (Katja), Toolenaar, T. (Toon), Steen, S.L. (Sanne) van der, Huijbregts, G.C.M. (Gido), Knijnenburg, J. (Jeroen), Vries, F.A.T. (Femke) de, Van Opstal, A.R.M. (Diane), Galjaard, R-J.H. (Robert-Jan), Govaerts, L.C. (Lutgarde), Srebniak, M.I. (Malgorzata), Diderich, K.E.M. (Karin), Joosten, A-M.S (Marieke), Riedijk, S.R. (Samantha), Knapen, M.F.C.M. (Maarten), Go, A.T.J.I. (Attie), Papatsonis, D.N.M. (Dimitri), de Graaf, K. (Katja), Toolenaar, T. (Toon), Steen, S.L. (Sanne) van der, Huijbregts, G.C.M. (Gido), Knijnenburg, J. (Jeroen), Vries, F.A.T. (Femke) de, Van Opstal, A.R.M. (Diane), and Galjaard, R-J.H. (Robert-Jan)

Abstract

__Background:__ Whole genome array testing not only provides an increased diagnostic yield of pathogenic causative findings, but it may also reveal so called susceptibility loci (SL) for neurodevelopmental disorders. The goal of this study was to evaluate the pregnancy outcomes in SL cases and to establish a protocol for pregnancy management, follow-up and additional investigations. __Methods:__ Fifty seven cases were evaluated: 34 with and 23 without ultrasound anomalies at referral. Each pregnant couple received pretest counseling and extensive posttest genetic counseling. __Results:__ After diagnosis of SL, parental testing and an additional ultrasound examination were offered. The severity of the ultrasound anomalies and not the diagnosis of SL was the most important factor contributing to the decision on pregnancy continuation. In the majority of cases with milder or no ultrasound anomalies, the pregnancy was continued and a normal outcome after birth was observed. __Conclusions:__ The diagnosis of a SL did not seem to be a reason for termination of pregnancy. Most patients were able to cope with the uncertainty and were interested in both prenatal and postnatal actionability of SL. Long-term follow-up is crucial to assess the actual risks for neurodevelopmental disorders, especially in families with unremarkable history.

Published
2017
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8. Effect of maintenance tocolysis with nifedipine in threatened preterm labor on perinatal outcomes: A randomized controlled trial

Author

Roos, C. (Carolien), Spaanderman, M.E.A., Schuit, E. (Ewoud), Bloemenkamp, K.W.M. (Kitty), Bolte, A.C. (Annemieke), Cornette, J.M.J. (Jérôme), Duvekot, J.J. (Hans), Eyck, J. (Jim) van, Franssen, M.T.M. (Maureen), Groot, C.J. (Christianne) de, Kok, J.H. (Joke), Kwee, A. (Anneke), Merién, A. (Ashley), Bijvank, B.N. (Bas Nij), Opmeer, B.C. (Brent), Oudijk, M.A. (Martijn), Pampus, M.G. (Marielle) van, Papatsonis, D.N.M. (Dimitri), Porath, M. (Martina), Scheepers, H.C.J. (Hubertina), Scherjon, S.A. (Sicco), Sollie, K.M. (Krystyna), Vijgen, S.M.C. (Sylvia), Willekes, C. (Christine), Mol, B.W.J. (Ben), Post, J.A.M. (Joris) van der, Lotgering, F.K. (Fred), Roos, C. (Carolien), Spaanderman, M.E.A., Schuit, E. (Ewoud), Bloemenkamp, K.W.M. (Kitty), Bolte, A.C. (Annemieke), Cornette, J.M.J. (Jérôme), Duvekot, J.J. (Hans), Eyck, J. (Jim) van, Franssen, M.T.M. (Maureen), Groot, C.J. (Christianne) de, Kok, J.H. (Joke), Kwee, A. (Anneke), Merién, A. (Ashley), Bijvank, B.N. (Bas Nij), Opmeer, B.C. (Brent), Oudijk, M.A. (Martijn), Pampus, M.G. (Marielle) van, Papatsonis, D.N.M. (Dimitri), Porath, M. (Martina), Scheepers, H.C.J. (Hubertina), Scherjon, S.A. (Sicco), Sollie, K.M. (Krystyna), Vijgen, S.M.C. (Sylvia), Willekes, C. (Christine), Mol, B.W.J. (Ben), Post, J.A.M. (Joris) van der, and Lotgering, F.K. (Fred)

Abstract

Importance: In threatened preterm labor, maintenance tocolysis with nifedipine, after an initial course of tocolysis and corticosteroids for 48 hours, may improve perinatal outcome. Objective: To determine whether maintenance tocolysis with nifedipine will reduce adverse perinatal outcomes due to premature birth. Design, Setting, and Participants: APOSTEL-II (Assessment of Perinatal Outcome with Sustained Tocolysis in Early Labor) is a double-blind, placebo-controlled trial performed in 11 perinatal units including all tertiary centers in the Netherlands. From June 2008 to February 2010, women with threatened preterm labor between 26 weeks (plus 0 days) and 32 weeks (plus 2 days) gestation, who had not delivered after 48 hours of tocolysis and a completed course of corticosteroids, were enrolled. Surviving infants were followed up until 6 months after birth (ended August 2010). Intervention: Randomization assigned 406 women to maintenance tocolysis with nifedipine orally (80 mg/d; n=201) or placebo (n=205) for 12 days. Assigned treatment was masked from investigators, participants, clinicians, and research nurses. Main Outcome Measures: Primary outc

Published
2013
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9. Correction: Pessaries in multiple pregnancy as a prevention of preterm birth: the ProTwin Trial

Author

Liem, S.M.S. (Sophie), Bekedam, D.J. (Dick), Bloemenkamp, K.W.M. (Kitty), Kwee, A. (Anneke), Papatsonis, D.N.M. (Dimitri), Post, J.A.M. (Joris) van der, Lim, A.C. (Arianne), Scheepers, H.C.J. (Hubertina), Willekes, C. (Christine), Duvekot, J.J. (Hans), Spaanderman, M.E.A., Porath, M. (Martina), Eyck, J. (Jim) van, Haak, M.C. (Monique), Pampus, M.G. (Marielle) van, Bruinse, H.W. (Hein), Mol, B.W.J. (Ben), Hegeman, M.A. (Maud), Liem, S.M.S. (Sophie), Bekedam, D.J. (Dick), Bloemenkamp, K.W.M. (Kitty), Kwee, A. (Anneke), Papatsonis, D.N.M. (Dimitri), Post, J.A.M. (Joris) van der, Lim, A.C. (Arianne), Scheepers, H.C.J. (Hubertina), Willekes, C. (Christine), Duvekot, J.J. (Hans), Spaanderman, M.E.A., Porath, M. (Martina), Eyck, J. (Jim) van, Haak, M.C. (Monique), Pampus, M.G. (Marielle) van, Bruinse, H.W. (Hein), Mol, B.W.J. (Ben), and Hegeman, M.A. (Maud)

Published
2012
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10. Prognostic models for stillbirth and neonatal death in very preterm birth: A validation study

Author

Schuit, E. (Ewoud), Hukkelhoven, C.W.P.M. (Chantal), Manktelow, B.N. (Bradley), Papatsonis, D.N.M. (Dimitri), Kleine, M.J.K. (Martin) de, Draper, E.S. (Elizabeth), Steyerberg, E.W. (Ewout), Vergouwe, Y. (Yvonne), Schuit, E. (Ewoud), Hukkelhoven, C.W.P.M. (Chantal), Manktelow, B.N. (Bradley), Papatsonis, D.N.M. (Dimitri), Kleine, M.J.K. (Martin) de, Draper, E.S. (Elizabeth), Steyerberg, E.W. (Ewout), and Vergouwe, Y. (Yvonne)

Abstract

OBJECTIVES: To validate externally 2 prognostic models for stillbirth and neonatal death in very preterm infants who are either known to be alive at the onset of labor or admitted for neonatal intensive care. PATIENTS AND METHODS: All infants, with gestational age 22 to 32 weeks, of European ethnicity, known to be alive at the onset of labor (n = 17 582) and admitted for neonatal intensive care (n = 11 578), who were born in the Netherlands between January 1, 2000, and December 31, 2007. The main outcome measures were stillbirth or death within 28 days for infants known to be alive at the onset of labor and death before discharge from the NICU for infants admitted for intensive care. Model performance was studied with calibration plots and c statistic. RESULTS: Of the infants known to be alive at the onset of labor, 16.7% (n = 2939) died during labor or within 28 days of birth, and 7.8% (n = 908) of the infants admitted for neonatal intensive care died before discharge from intensive care. The prognostic model for infants known to be alive at the onset of labor showed good calibration and excellent discrimination (c statistic 0.92). The prognostic model for infants admitted for neonatal intensive care showed good calibration and good discrimination (c statistic 0.82). CONCLUSIONS: The 2 prognostic models for stillbirth and neonatal death in very preterm Dutch infants showed good performance, suggesting their use in clinical practice in the Netherlands and possibly other Western countries. Copyright

Published
2012
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11. Well being of obstetric patients on minimal blood transfusions (WOMB trial)

Author

Prick, B.W. (Babette), Steegers, E.A.P. (Eric), Jansen, A.G. (Gerard), Hop, W.C.J. (Wim), Essink-Bot, M.L.E. (Marie-Louise), Peters, N.C.J. (Nina), Uyl-de Groot, C.A. (Carin), Papatsonis, D.N.M. (Dimitri), Akerboom, B.M.C. (Bettina), Metz, G.C.H. (Godfried), Bremer, H.A. (Henk), Loon, A.J. (Aren) van, Stigter, R.H. (Rob), Post, J.A.M. (Joris) van der, Alphen, M. (Marcel) van, Porath, M. (Martina), Rijnders, R.J.P. (Robbert), Spaanderman, M.E.A., Schippers, D.H. (Daniela), Bloemenkamp, K.W.M. (Kitty), Boers, K.E. (Kim), Scheepers, H.C.J., Roumen, F.J.M.E. (Frans), Kwee, A. (Anneke), Schuitemaker, N.W.E. (Nico), Mol, B.W.J. (Ben), Rhenen, D.J. (Dirk Jan) van, Duvekot, J.J. (Hans), Prick, B.W. (Babette), Steegers, E.A.P. (Eric), Jansen, A.G. (Gerard), Hop, W.C.J. (Wim), Essink-Bot, M.L.E. (Marie-Louise), Peters, N.C.J. (Nina), Uyl-de Groot, C.A. (Carin), Papatsonis, D.N.M. (Dimitri), Akerboom, B.M.C. (Bettina), Metz, G.C.H. (Godfried), Bremer, H.A. (Henk), Loon, A.J. (Aren) van, Stigter, R.H. (Rob), Post, J.A.M. (Joris) van der, Alphen, M. (Marcel) van, Porath, M. (Martina), Rijnders, R.J.P. (Robbert), Spaanderman, M.E.A., Schippers, D.H. (Daniela), Bloemenkamp, K.W.M. (Kitty), Boers, K.E. (Kim), Scheepers, H.C.J., Roumen, F.J.M.E. (Frans), Kwee, A. (Anneke), Schuitemaker, N.W.E. (Nico), Mol, B.W.J. (Ben), Rhenen, D.J. (Dirk Jan) van, and Duvekot, J.J. (Hans)

Abstract

Background: Primary postpartum haemorrhage is an obstetrical emergency often causing acute anaemia that may require immediate red blood cell (RBC) transfusion. This anaemia results in symptoms such as fatigue, which

Published
2010
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12. Pessaries in multiple pregnancy as a prevention of preterm birth: The ProTwin trial

Author

Hegeman, M.A. (Maud), Bekedam, D.J. (Dick), Bloemenkamp, K.W.M. (Kitty), Kwee, A. (Anneke), Papatsonis, D.N.M. (Dimitri), Post, J.A.M. (Joris) van der, Lim, A.C. (Arianne), Scheepers, H.C.J. (Hubertina), Willekes, C. (Christine), Duvekot, J.J. (Hans), Spaanderman, M.E.A., Porath, M. (Martina), Eyck, J. (Jim) van, Haak, M.C. (Monique), Pampus, M.G. (Marielle) van, Bruinse, H.W. (Hein), Mol, B.W.J. (Ben), Hegeman, M.A. (Maud), Bekedam, D.J. (Dick), Bloemenkamp, K.W.M. (Kitty), Kwee, A. (Anneke), Papatsonis, D.N.M. (Dimitri), Post, J.A.M. (Joris) van der, Lim, A.C. (Arianne), Scheepers, H.C.J. (Hubertina), Willekes, C. (Christine), Duvekot, J.J. (Hans), Spaanderman, M.E.A., Porath, M. (Martina), Eyck, J. (Jim) van, Haak, M.C. (Monique), Pampus, M.G. (Marielle) van, Bruinse, H.W. (Hein), and Mol, B.W.J. (Ben)

Abstract

Background: Multiple pregnancies are at high risk for preterm birth, and therefore an important cause of infant mortality and morbidity. A pessary is a simple and potentially effective measure for the prevention of preterm birth. Small studies have indicated its effectiveness, but large studies with sufficient power on the subject are lacking. Despite this lack of evidence, the treatment is at present applied by some gynaecologists in The Netherlands. Methods/Design: We aim to investigate the hypothesis that prophylactic use of a cervical pessary will be effective in the prevention of preterm delivery and the neonatal mortality and morbidity resulting from preterm delivery in multiple pregnancy. We will evaluate the costs and effects of this intervention. At study entry, cervical length will be measured. Eligible women will be randomly allocated to receive either a cervical pessary or no intervention. The cervical pessary will be placed in situ at 16 to 20 weeks, and will stay in situ up to 36 weeks gestation or until delivery, whatever comes first. Discussion

Published
2009
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13. Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial)

Author

Roos, C. (Carolien), Scheepers, L.H.C.J. (Liesbeth), Bloemenkamp, K.W.M. (Kitty), Bolte, A.C. (Annemieke), Cornette, J.M.J. (Jérôme), Derks, J.B. (Jan), Duvekot, J.J. (Hans), Eyck, J. (Jim) van, Kok, J.H. (Joke), Kwee, A. (Anneke), Merién, A. (Ashley), Opmeer, B.C. (Brent), Pampus, M.G. (Mariëlle) van, Papatsonis, D.N.M. (Dimitri), Porath, M. (Martina), Post, J.A.M. (Joris) van der, Scherjon, S.A. (Sico), Sollie, K. (Krystyne), Spaanderman, M.E.A., Vijgen, S.M.C. (Sylvia), Willekes, C. (Christine), Mol, B.W.J. (Ben), Lotgering, F.K. (Fred), Roos, C. (Carolien), Scheepers, L.H.C.J. (Liesbeth), Bloemenkamp, K.W.M. (Kitty), Bolte, A.C. (Annemieke), Cornette, J.M.J. (Jérôme), Derks, J.B. (Jan), Duvekot, J.J. (Hans), Eyck, J. (Jim) van, Kok, J.H. (Joke), Kwee, A. (Anneke), Merién, A. (Ashley), Opmeer, B.C. (Brent), Pampus, M.G. (Mariëlle) van, Papatsonis, D.N.M. (Dimitri), Porath, M. (Martina), Post, J.A.M. (Joris) van der, Scherjon, S.A. (Sico), Sollie, K. (Krystyne), Spaanderman, M.E.A., Vijgen, S.M.C. (Sylvia), Willekes, C. (Christine), Mol, B.W.J. (Ben), and Lotgering, F.K. (Fred)

Abstract

Background: Preterm labour is the main cause of perinatal morbidity and mortality in the Western world. At present, there is evidence that tocolysis for 48 hours is useful in women with threatened preterm labour at least before 32 weeks. This allows transfer of the patient to a perinatal centre, and maximizes the effect of corticosteroids for improved neonatal survival. It is questionable whether treatment with tocolytics should be maintained after 48 hours. Methods/Design: The APOSTEL II trial is a multicentre placebo-controlled study. Pregnant women admitted for threatened preterm labour who have been treated with 48 hours corticosteroids and tocolysis will be eligible to participate in the trial between 26+0and 32+2weeks gestational age. They will be randomly allocated to nifedipine (intervention) or placebo (control) for twelve days or until delivery, whatever comes first. Discussion: Primary outcome is a composite of perinatal death, and severe neonatal morbidity up to evaluation at 6 months after birth. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days of the first 6 months out of hospital. In addition a cost-effectiveness analysis will be performed. Analysis will be by intention to treat. The power calculation is based on an expected 11% difference in adverse neonatal outcome. This implies that 406 women have to be randomis

Published
2009
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