Cervical pessary versus vaginal progesterone in women with a singleton pregnancy, a short cervix, and no history of spontaneous preterm birth at less than 34 weeks' gestation: open label, multicentre, randomised, controlled trial.

Autor:	van Dijk CE; Department of Obstetrics and Gynaecology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands c.e.vandijk@amsterdamumc.nl.; Amsterdam Reproduction and Development Research Institute, Amsterdam, Netherlands., van Gils AL; Department of Obstetrics and Gynaecology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.; Amsterdam Reproduction and Development Research Institute, Amsterdam, Netherlands., van Zijl MD; Department of Obstetrics and Gynaecology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.; Amsterdam Reproduction and Development Research Institute, Amsterdam, Netherlands., Koullali B; Department of Obstetrics and Gynaecology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.; Amsterdam Reproduction and Development Research Institute, Amsterdam, Netherlands., van der Weide MC; Department of Obstetrics and Gynaecology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands., van den Akker ES; Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands., Hermsen BJ; Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands., van Baal WM; Department of Obstetrics and Gynaecology, Flevoziekenhuis, Almere, Netherlands., Visser H; Department of Obstetrics and Gynaecology, Ter Gooi Medical Center, Blaricum, Netherlands., van Drongelen J; Department of Obstetrics and Gynaecology, Radboud University Medical Centre, Radboud University, Nijmegen, Netherlands., Vollebregt KC; Department of Obstetrics and Gynaecology, Spaarne Gasthuis, Haarlem, Netherlands., Muller M; Department of Obstetrics and Gynaecology, Spaarne Gasthuis, Haarlem, Netherlands., van der Made FW; Department of Obstetrics and Gynaecology, Sint Fransiscus Gasthuis, Rotterdam, Netherlands., Gordijn SJ; Department of Obstetrics, University Medical Centre Groningen, University of Groningen, Groningen, Netherlands., de Mooij YM; Department of Obstetrics and Gynaecology, Zaans Medisch Centrum, Zaandam, Netherlands., Oudijk MA; Amsterdam Reproduction and Development Research Institute, Amsterdam, Netherlands.; Department of Obstetrics and Gynaecology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands., de Boer MA; Amsterdam Reproduction and Development Research Institute, Amsterdam, Netherlands.; Department of Obstetrics and Gynaecology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands., Mol BW; Department of Obstetrics and Gynaecology, Monash University, Clayton, Australia.; Aberdeen Centre for Women's Health Research, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK., Kazemier BM; Department of Obstetrics, Wilhelmina's Children Hospital, UMC Utrecht, Utrecht, Netherlands., Pajkrt E; Department of Obstetrics and Gynaecology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.; Amsterdam Reproduction and Development Research Institute, Amsterdam, Netherlands.
Jazyk:	angličtina
Zdroj:	BMJ (Clinical research ed.) [BMJ] 2024 Mar 12; Vol. 384, pp. e077033. Date of Electronic Publication: 2024 Mar 12.
DOI:	10.1136/bmj-2023-077033
Abstrakt:	Objective: To compare the effectiveness of cervical pessary and vaginal progesterone in the prevention of adverse perinatal outcomes and preterm birth in pregnant women of singletons with no prior spontaneous preterm birth at less than 34 weeks' gestation and who have a short cervix of 35 mm or less. Design: Open label, multicentre, randomised, controlled trial. Setting: 20 hospitals and five obstetric ultrasound practices in the Netherlands. Participants: Women with a healthy singleton pregnancy and an asymptomatic short cervix of 35 mm or less between 18 and 22 weeks' gestation were eligible. Exclusion criteria were prior spontaneous preterm birth at less than 34 weeks, a cerclage in situ, maternal age of younger than 18 years, major congenital abnormalities, prior participation in this trial, vaginal blood loss, contractions, cervical length of less than 2 mm or cervical dilatation of 3 cm or more. Sample size was set at 628 participants. Interventions: 1:1 randomisation to an Arabin cervical pessary or vaginal progesterone 200 mg daily up to 36 weeks' of gestation or earlier in case of ruptured membranes, signs of infection, or preterm labour besides routine obstetric care. Main Outcome Measures: Primary outcome was a composite adverse perinatal outcome. Secondary outcomes were rates of (spontaneous) preterm birth at less than 28, 32, 34, and 37 weeks. A predefined subgroup analysis was planned for cervical length of 25 mm or less. Results: From 1 July 2014 to 31 March 2022, 635 participants were randomly assigned to pessary (n=315) or to progesterone (n=320). 612 were included in the intention to treat analysis. The composite adverse perinatal outcome occurred in 19 (6%) of 303 participants with a pessary versus 17 (6%) of 309 in the progesterone group (crude relative risk 1.1 (95% confidence interval (CI) 0.60 to 2.2)). The rates of spontaneous preterm birth were not significantly different between groups. In the subgroup of cervical length of 25 mm or less, spontaneous preterm birth at less than 28 weeks occurred more often after pessary than after progesterone (10/62 (16%) v 3/69 (4%), relative risk 3.7 (95% CI 1.1 to 12.9)) and adverse perinatal outcomes seemed more frequent in the pessary group (15/62 (24%) v 8/69 (12%), relative risk 2.1 (0.95 to 4.6)). Conclusions: In women with a singleton pregnancy with no prior spontaneous preterm birth at less than 34 weeks' gestation and with a midtrimester short cervix of 35 mm or less, pessary is not better than vaginal progesterone. In the subgroup of a cervical length of 25 mm or less, a pessary seemed less effective in preventing adverse outcomes. Overall, for women with single baby pregnancies, a short cervix, and no prior spontaneous preterm birth less than 34 weeks' gestation, superiority of a cervical pessary compared with vaginal progesterone to prevent preterm birth and consecutive adverse outcomes could not be proven. Trial Registration: International Clinical Trial Registry Platform (ICTRP, EUCTR2013-002884-24-NL). Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest and declare: BWJM declared support by a NHMRC Investigator grant (GNT1176437). BWM reports consultancy, research funding and travel support from Merck. EP and MAO declared participation on the board of the Research foundation ‘Stichting Stoptevroegbevallen’ that supported this study. EP, MAO and SJG received several grants with the purpose of scientific research in the field op preterm birth and fetal growth restriction. All other authors declare no support from any organisation for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work. (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu