1. Long-term follow-up of children exposed in-utero to progesterone treatment for prevention of preterm birth: study protocol of the AMPHIA follow-up
- Author
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Rebecca C Painter, Martijn A Oudijk, Jaap Oosterlaan, Martijn J J Finken, Cornelieke S H Aarnoudse-Moens, Madelon van Wely, Eva Pajkrt, Marjon A de Boer, M Kramer, Tessa J Roseboom, Aleid G van Wassenaer-Leemhuis, J J Duvekot, N M Vink, M A Oudijk, J van Eyck, H C J Scheepers, S Smits, Noor E Simons, D P van der Ham, W J Van Wijngaarden, D N M Papatsonis, Emilie V J van Limburg Stirum, Anneloes van Baar, Arianne C Lim, Janneke van t Hooft, B M C Akerboom, J Olsthoorn, M A de Boer, J J H Bakker, S M Ratsma, J Catineau, N M van der Velde, D H Schippers, M E M H Westerhuis, K Slobben, T E Vogelvang, T Voogt, J van de Ven, W M van Baal, G Meertens, N van Gemund, A van Oosten, A Ritman, C A van Meir, M R Douma, N C W van Rijn, R J P Rijnders, M Linders, M Sueters, M L Tendeloo-Klarenbeek, E C Haagen, E Gortmaker, T A van Dooren, L E Hamming, FJ Kortweg, J O E H van Laar, S van Weelden, P C M van der Salm, M S Post, J A Kroese, J Sikkema, S Arendsen-Meijer, M de Hundt, B Kruitbosch-Groen, E S A van den Akker, E Moll, M G van Pampus, L Videler-Sinke, F Makhloufi, R ScholtenG Zijderveld, H A Bremer, A van der Ster, K de Boer, M J Pelink, K C Vollebregt, F van de Crommenacker, W M Klerkx, K Swarts, S V Koenen, L C M van Egeraat, E C van Asbeck, J Beutler, V de Zeeuw, S J Gordijn, J H M Keurentjes, M N Bekker, ME de Reus, H H J Monteiro, R van de Laar, AB Hooker, J Langenveld, J Willems-Robberts, Leerstoel Baar, Development and Treatment of Psychosocial Problems, Leerstoel Bogt, Graduate School, APH - Aging & Later Life, APH - Health Behaviors & Chronic Diseases, Amsterdam Reproduction & Development (AR&D), Obstetrics and Gynaecology, Neonatology, Other Research, Paediatric Psychosocial Care, General Paediatrics, Epidemiology and Data Science, Center for Reproductive Medicine, APH - Methodology, APH - Personalized Medicine, APH - Quality of Care, RS: GROW - R4 - Reproductive and Perinatal Medicine, Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), Pediatric surgery, Amsterdam Gastroenterology Endocrinology Metabolism, and Obstetrics and gynaecology
- Subjects
Male ,fetal medicine ,Pediatrics ,medicine.medical_specialty ,Adolescent ,MULTICENTER ,TWIN ,BEHAVIOR RATING INVENTORY ,Placebo ,Multiple Gestation ,DELIVERY ,perinatology ,Pregnancy ,Obstetrics and Gynaecology ,Medicine ,Humans ,Multicenter Studies as Topic ,Risk factor ,METAANALYSIS ,Progesterone ,Randomized Controlled Trials as Topic ,Protocol (science) ,maternal medicine ,business.industry ,Infant, Newborn ,Infant ,Gender Identity ,BORN PRETERM ,General Medicine ,Newborn ,medicine.disease ,Child development ,Premature Birth/prevention & control ,In utero ,Premature Birth ,developmental neurology & neurodisability ,Gestation ,TRIAL ,Female ,Pregnancy, Multiple ,business ,Multiple ,17-ALPHA-HYDROXYPROGESTERONE CAPROATE ,Follow-Up Studies - Abstract
IntroductionPreterm birth is one of the main problems in obstetrics, and the most important cause of neonatal mortality, morbidity and neurodevelopmental impairment. Multiple gestation is an important risk factor for preterm birth, with up to 50% delivering before 37 weeks. Progesterone has a role in maintaining pregnancy and is frequently prescribed to prevent (recurrent) preterm birth and improve pregnancy outcomes in high-risk patients. However, little is known about its long-term effects in multiple gestations. The objective of this follow-up study is to assess long-term benefits and harms of prenatal exposure to progesterone treatment in multiple gestations on child development.Methods and analysisThis is a follow-up study of a multicentre, double-blind, placebo-controlled randomised trial (AMPHIA trial, ISRCTN40512715). Between 2006 and 2009 women with a multiple gestation were randomised at 16–20 weeks of gestation to weekly injections 250 mg 17α-hydroxyprogesterone caproate or placebo, until 36 weeks of gestation or delivery. The current long-term follow-up will assess all children (n=1355) born to mothers who participated in the AMPHIA trial, at 11–14 years of age, with internationally validated questionnaires, completed by themselves, their parents and their teachers.Main outcomes are child cognition and behaviourAdditional outcomes are death (perinatal and up to age 14), gender identity, educational performance and health-related problems. We will use intention-to-treat analyses comparing experimental and placebo group. To adjust for the correlation between twins, general linear mixed-effects models will be used.Ethics and disseminationAmsterdam UMC MEC provided a waiver for the Medical Research Involving Human Subjects Act (W20_234#20.268). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders, patients and participants. This protocol is published before analysis of the results.Trial registration numberNL8933.
- Published
- 2021