Pessary or progesterone to prevent preterm birth in women with short cervical length: protocol of the 4–6 year follow-up of a randomised controlled trial (Quadruple-P)

• Published in: BMJ open Vol. 12; no. 8; p. e064049
• Main Authors: van Limburg Stirum, Emilie V J, van der Windt, Larissa I, van Dijk, Charlotte E, van Baar, Anneloes L, Leemhuis, Aleid G, van Wely, Madelon, de Boer, Marjon A, van 't Hooft, Janneke, Oudijk, Martijn A, Pajkrt, Eva
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group 24.08.2022
• Series: Protocol
• Subjects: Cervical Length Measurement; Cervix Uteri - diagnostic imaging; Child; Female; Follow-Up Studies; Humans; Infant, Newborn; Multicenter Studies as Topic; Obstetrics and Gynaecology; Pessaries; Pregnancy; Premature Birth - prevention & control; Progesterone - therapeutic use; Randomized Controlled Trials as Topic; Fetal medicine; Developmental neurology & neurodisability; Maternal medicine
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2022-064049

Vaginal progesterone and a cervical pessary are both interventions that are investigated for the prevention of preterm birth (PTB). Thus far, beneficial or harmful effects of these interventions on long-term child health and development are described, but evidence is not robust enough to draw firm conclusions. With this follow-up study, we intent to investigate if progesterone or a pessary is superior for the prevention of PTB considering the child's health at 4-6 years of corrected age. This study is a follow-up study of the Quadruple-P trial; a multicentre, randomised clinical trial (NL42926.018.13, Eudractnumber 2013-002884-24) which randomises women with an asymptomatic midtrimester short cervix to daily progesterone or a pessary for the prevention of PTB. All children born to mothers who participated in the Quadruple-P study (n=628 singletons and n=332 multiples) will be eligible for follow-up at 4-6 years of corrected age. Children will be assessed using parental questionnaires. Main outcomes are child (neuro)development and behaviour. Other outcomes include child mortality, growth and general health. A composite of adverse child outcomes will be compared between the progesterone and pessary groups reporting OR and the corresponding 95% CI. Analyses will be performed separately for singletons and multiples and using the intention-to-treat approach. The Medical Research Ethics Committee from Amsterdam UMC confirmed that de Medical Research Involving Human Subjects Act (WMO) did not apply to our study (W20_481 #20.531). Results will be published in a peer-reviewed journal and shared with stakeholders and participants. This protocol is published before analysis of the results. Dutch Trial Register (NL9646).