Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC Location AMC, Amsterdam, The Netherlands
Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC Location AMC, Amsterdam, The Netherlands.
BMJ Open. 2021 Sep 21;11(9):e053066. doi: 10.1136/bmjopen-2021-053066.
Preterm 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.
This 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.
Additional 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.
Amsterdam 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.
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早产是产科的主要问题之一，也是新生儿死亡、发病和神经发育障碍的最重要原因。多胎妊娠是早产的一个重要危险因素，多达 50%的多胎妊娠会在 37 周前分娩。孕酮在维持妊娠中起作用，常用于预防（复发性）早产，并改善高危患者的妊娠结局。然而，人们对其在多胎妊娠中的长期作用知之甚少。本随访研究旨在评估多胎妊娠中产前孕酮治疗对儿童发育的长期益处和危害。
这是一项多中心、双盲、安慰剂对照随机试验（AMPHIA 试验，ISRCTN40512715）的随访研究。2006 年至 2009 年间，16-20 周妊娠的多胎妊娠妇女被随机分为每周注射 250mg 17α-羟孕酮己酸酯或安慰剂组，直至 36 周妊娠或分娩。目前的长期随访将评估所有参加 AMPHIA 试验的母亲所生的 1355 名儿童（n=1355），在 11-14 岁时，使用国际上经过验证的问卷，由他们自己、他们的父母和他们的老师完成。
其他结局是死亡（围产期和 14 岁以下）、性别认同、教育表现和与健康相关的问题。我们将使用意向治疗分析比较实验组和安慰剂组。为了调整双胞胎之间的相关性，将使用广义线性混合效应模型。
阿姆斯特丹 UMC MEC 豁免了涉及人类受试者的医学研究法（W20_234#20.268）。结果将通过同行评议的期刊发表，并与利益相关者、患者和参与者分享摘要。本方案在分析结果之前公布。
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