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1. Single- versus double-layer closure of the caesarean (uterine) scar in the prevention of gynaecological symptoms in relation to niche development – the 2Close study: a multicentre randomised controlled trial

Author

Stegwee, S. I., Jordans, I. P. M., van der Voet, L. F., Bongers, M. Y., de Groot, C. J. M., Lambalk, C. B., de Leeuw, R. A., Hehenkamp, W. J. K., van de Ven, P. M., Bosmans, J. E., Pajkrt, E., Bakkum, E. A., Radder, C. M., Hemelaar, M., van Baal, W. M., Visser, H., van Laar, J. O. E. H., van Vliet, H. A. A. M., Rijnders, R. J. P., Sueters, M., Janssen, C. A. H., Hermes, W., Feitsma, A. H., Kapiteijn, K., Scheepers, H. C. J., Langenveld, J., de Boer, K., Coppus, S. F. P. J., Schippers, D. H., Oei, A. L. M., Kaplan, M., Papatsonis, D. N. M., de Vleeschouwer, L. H. M., van Beek, E., Bekker, M. N., Huisjes, A. J. M., Meijer, W. J., Deurloo, K. L., Boormans, E. M. A., van Eijndhoven, H. W. F., and Huirne, J. A. F.

Published
2019
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2. Effect of single- versus double-layer uterine closure during caesarean section on postmenstrual spotting (2Close): multicentre, double-blind, randomised controlled superiority trial

Author

Stegwee, S. I., van der Voet, L. F., Ben, A. J., de Leeuw, R. A., van de Ven, P. M., Duijnhoven, R. G., Bongers, M. Y., Lambalk, C. B., de Groot, C. J. M., Huirne, J. A. F., Papatsonis, Dimitri N. M., Pajkrt, Eva, Hehenkamp, Wouter J. K., Oei, Angèle L. M., Bekker, Mireille N., Schippers, Daniela H., van Vliet, Huib A. AM, van der Voet, Lucet, Schuitemaker, Nico W. E., Hemelaar, Majoie, van Baal, W. M., Huisjes, Anjoke J. M., Meijer, Wouter J., Janssen, C. A. H., Hermes, Wietske, Feitsma, A. H., van Eijndhoven, Hugo W. F., Rijnders, Robbert J. P., Sueters, Marieke, Scheepers, H. C. J., van Laar, Judith O. EH, Boormans, Elisabeth M. A., van Kesteren, Paul J. M., Radder, Celine M., Hink, Esther, Kapiteijn, Kitty, de Boer, Karin, Kaplan, Mesrure, van Beek, Erik, de Vleeschouwer, L. H. M., Visser, Harry, Bosmans, Judith E., el Alili, Mohamed, Langenveld, Josje, RS: GROW - R4 - Reproductive and Perinatal Medicine, Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), Health Economics and Health Technology Assessment, Amsterdam Public Health, Science and Society, APH - Mental Health, APH - Methodology, Obstetrics and Gynaecology, APH - Personalized Medicine, APH - Quality of Care, ARD - Amsterdam Reproduction and Development, Obstetrics and gynaecology, Amsterdam Reproduction & Development (AR&D), Epidemiology and Data Science, ACS - Heart failure & arrhythmias, APH - Societal Participation & Health, Other Research, and Cardiology

Subjects
SYMPTOMS, medicine.medical_treatment, CORONIS, Postoperative Complications, 0302 clinical medicine, Superiority Trial, Pregnancy, uterine closure technique, Medicine and Health Sciences, Caesarean section, Menstruation Disturbances, media_common, education.field_of_study, OUTCOMES, 030219 obstetrics & reproductive medicine, Obstetrics, NICHE, Obstetrics and Gynecology, PREVALENCE, Treatment Outcome, Female, Adult, medicine.medical_specialty, INCISION, media_common.quotation_subject, Population, TERM, Postmenstrual spotting, Double blind, 03 medical and health sciences, single layer, Double-Blind Method, medicine, Humans, Closure (psychology), education, Menstrual cycle, Cesarean Section, business.industry, Suture Techniques, Perioperative, SCAR, FACTORIAL, Linear Models, RISK-FACTORS, double layer, postmenstrual spotting, business, Follow-Up Studies
Abstract

Objective To evaluate whether double-layer uterine closure after a first caesarean section (CS) is superior compared with single-layer uterine closure in terms of postmenstrual spotting and niche development in the uterine caesarean scar.Design Multicentre, double-blind, randomised controlled superiority trial.Setting Thirty-two hospitals in the Netherlands.Population A total of 2292 women aged >= 18 years undergoing a first CS were randomly assigned to each procedure (1:1): 1144 women were assigned to single-layer uterine closure and 1148 women were assigned to double-layer uterine closure.Methods Single-layer unlocked closure and double-layer unlocked closure, with the second layer imbricating the first.Main outcome measures Number of days with postmenstrual spotting during one menstrual cycle 9 months after CS. Secondary outcomes: perioperative and menstrual characteristics; transvaginal ultrasound measurements.Results A total of 774 (67.7%) women from the single-layer group and 770 (67.1%) women from the double-layer group were evaluable for the primary outcome, as a result of drop-out and amenorrhoea. The mean number of postmenstrual spotting days was 1.33 (bootstrapped 95% CI 1.12-1.54) after single-layer closure and 1.26 (bootstrapped 95% CI 1.07-1.45) after double-layer closure (adjusted mean difference -0.07, 95% CI -0.37 to 0.22, P = 0.810). The operative time was 3.9 minutes longer (95% CI 3.0-4.9 minutes, P < 0.001) and niche prevalence was 4.7% higher (95% CI 0.7-8.7%, P = 0.022) after double-layer closure.Conclusions The superiority of double-layer closure compared with single-layer closure in terms of postmenstrual spotting after a first CS was not shown. Long-term obstetric follow-up of our trial is needed to assess whether uterine caesarean closure guidelines should be adapted.Tweetable abstract Double-layer uterine closure is not superior for postmenstrual spotting after a first caesarean; single-layer closure performs slightly better on other outcomes.

Published
2021

3. Single- versus double-layer closure of the caesarean (uterine) scar in the prevention of gynaecological symptoms in relation to niche development - the 2Close study: a multicentre randomised controlled trial

Author

Arts-assistenten Kinderen, Orthopaedie Opleiding, Regenerative Medicine and Stem Cells, MS Reumatologie/Immunologie/Infectie, Infection & Immunity, MS Verloskunde, Child Health, Arts-assistenten DV&B, Stegwee, S I, Jordans, I P M, van der Voet, L F, Bongers, M Y, de Groot, C J M, Lambalk, C B, de Leeuw, R A, Hehenkamp, W J K, van de Ven, P M, Bosmans, J E, Pajkrt, E, Bakkum, E A, Radder, C M, Hemelaar, M, van Baal, W M, Visser, H, van Laar, J O E H, van Vliet, H A A M, Rijnders, R J P, Sueters, M, Janssen, C A H, Hermes, W, Feitsma, A H, Kapiteijn, K, Scheepers, H C J, Langenveld, J, de Boer, K, Coppus, S F P J, Schippers, D H, Oei, A L M, Kaplan, M, Papatsonis, D N M, de Vleeschouwer, L H M, van Beek, E, Bekker, M N, Huisjes, A J M, Meijer, W J, Deurloo, K L, Boormans, E M A, van Eijndhoven, H W F, Huirne, J A F, Arts-assistenten Kinderen, Orthopaedie Opleiding, Regenerative Medicine and Stem Cells, MS Reumatologie/Immunologie/Infectie, Infection & Immunity, MS Verloskunde, Child Health, Arts-assistenten DV&B, Stegwee, S I, Jordans, I P M, van der Voet, L F, Bongers, M Y, de Groot, C J M, Lambalk, C B, de Leeuw, R A, Hehenkamp, W J K, van de Ven, P M, Bosmans, J E, Pajkrt, E, Bakkum, E A, Radder, C M, Hemelaar, M, van Baal, W M, Visser, H, van Laar, J O E H, van Vliet, H A A M, Rijnders, R J P, Sueters, M, Janssen, C A H, Hermes, W, Feitsma, A H, Kapiteijn, K, Scheepers, H C J, Langenveld, J, de Boer, K, Coppus, S F P J, Schippers, D H, Oei, A L M, Kaplan, M, Papatsonis, D N M, de Vleeschouwer, L H M, van Beek, E, Bekker, M N, Huisjes, A J M, Meijer, W J, Deurloo, K L, Boormans, E M A, van Eijndhoven, H W F, and Huirne, J A F

Published
2019

5. Induction of Labour at Term With Oral Misoprostol Versus a Foley Catheter (PROBAAT-II): A Multicentre Randomized Controlled Noninferiority Trial.

Author

Eikelder, Mieke L.G. Ten, Rengerink, Katrien O., Jozwiak, Marta, de Leeuw, Jan W., de Graaf, Irene M., van Pampus, Mariëlle G., Holswilder, Marloes, Oudijk, Martijn A., van Baaren, Gert-Jan, Pernet, Paula J.M., Bax, Caroline, van Unnik, Gijs A., Martens, Gratia, Porath, Martina, van Vliet, Huib, Rijnders, Robbert J. P., Feitsma, A. H., Roumen, Frans J. M. E., van Loon, Aren J., and Versendaal, Hans

Published
2017
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6. [Pharmacological treatment of asthma during pregnancy].

Author

van Nederveen-Bendien SA, van Oord-Bosselaar SRJ, Feitsma AH, and Kappen JH

Subjects
Abnormalities, Drug-Induced, Administration, Inhalation, Adult, Anti-Asthmatic Agents administration & dosage, Female, Humans, Preconception Care, Pregnancy, Premature Birth etiology, Risk Factors, Anti-Asthmatic Agents adverse effects, Asthma drug therapy, Pregnancy Complications drug therapy
Abstract

- Asthma during pregnancy is associated with an increased risk of preterm delivery, low birth weight and pre-eclampsia.- This condition may be undertreated due to insufficient knowledge and, in particular, concerns about teratogenic effects of asthma medication among treating healthcare professionals and pregnant women.- The risk of teratogenic effects of inhaled medications (ICS, SABA and LABA) is small. These agents have been used by large groups of patients for many years.- Well-controlled asthma with pharmacological therapy during pregnancy is safer and leads to fewer complications then accepting asthma symptoms and exacerbations.- Preconception care for a woman with asthma who is treated with medication is recommended.

Published
2018

7. Amnioinfusion to facilitate external cephalic version after initial failure.

Author

Adama van Scheltema PN, Feitsma AH, Middeldorp JM, Vandenbussche FP, and Oepkes D

Subjects
Adult, Dose-Response Relationship, Drug, Female, Gestational Age, Humans, Infusions, Parenteral methods, Parity, Pregnancy, Prospective Studies, Ringer's Solution, Tocolysis, Treatment Failure, Ultrasonography, Prenatal, Amnion, Breech Presentation, Delivery, Obstetric methods, Isotonic Solutions administration & dosage, Version, Fetal methods
Abstract

Objective: To evaluate the effectiveness of antepartum transabdominal amnioinfusion to facilitate external cephalic version after initial failure., Methods: Women with a structurally normal fetus in breech lie at term, with a failed external cephalic version and an amniotic fluid index (AFI) less than 15 cm, were asked to participate in our study. After tocolysis with indomethacin, a transabdominal amnioinfusion was performed with an 18G spinal needle. Lactated Ringers solution was infused until the AFI reached 15 cm, with a maximum of 1 L. External cephalic version was performed directly afterward., Results: Seven women participated in the study. The gestational age of the women was between 36(+4) and 38(+3) weeks, and three women were primiparous. The AFI ranged from 4 cm to 13 cm. A median amount of 1,000 mL Ringers solution (range 700-1,000 mL) was infused per procedure. The repeat external cephalic versions after amnioinfusion were not successful in any of the patients., Conclusion: In our experience, amnioinfusion does not facilitate external cephalic version.

Published
2006
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