Prevention of preterm delivery with vaginal progesterone in women with preterm labour (4P): randomised double‐blind placebo‐controlled trial

Objective To evaluate the effectiveness of 200 mg of daily vaginal natural progesterone to prevent preterm birth in women with preterm labour. Design Multicentre, randomised, double‐blind, placebo‐controlled trial. Setting Twenty‐nine centres in Switzerland and Argentina. Population A total of 385 w...

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Published in:	BJOG : an international journal of obstetrics and gynaecology Vol. 122; no. 1; pp. 80 - 91
Main Authors:	Martinez de Tejada, B, Karolinski, A, Ocampo, MC, Laterra, C, Hösli, I, Fernández, D, Surbek, D, Huespe, M, Drack, G, Bunader, A, Rouillier, S, López de Degani, G, Seidenstein, E, Prentl, E, Antón, J, Krähenmann, F, Nowacki, D, Poncelas, M, Nassif, JC, Papera, R, Tuma, C, Espoile, R, Tiberio, O, Breccia, G, Messina, A, Peker, B, Schinner, E, Mol, BW, Kanterewicz, L, Wainer, V, Boulvain, M, Othenin‐Girard, V, Bertolino, MV, Irion, O
Format:	Journal Article
Language:	English
Published:	England Wiley Subscription Services, Inc 01-01-2015
Subjects:	Administration, Intravaginal Adult Apgar Score Birth Weight Double-Blind Method Female Humans Indomethacin - therapeutic use Infant Infant Mortality Infant, Newborn Intensive Care Units, Neonatal - utilization Maternal tolerance neonatal morbidity neonatal mortality neonatology Obstetric Labor, Premature - drug therapy obstetrics Pregnancy Pregnancy Trimester, Second Pregnancy Trimester, Third Premature birth Premature Birth - prevention & control Premature labor preterm delivery preterm labour Preventive medicine Progesterone Progesterone - therapeutic use Progestins - therapeutic use Receptors, Oxytocin - antagonists & inhibitors Tocolytic Agents - therapeutic use vaginal progesterone Young Adult Switzerland neonatology vaginal progesterone preterm labour neonatal mortality neonatal morbidity obstetrics Maternal tolerance preterm delivery
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Summary:	Objective To evaluate the effectiveness of 200 mg of daily vaginal natural progesterone to prevent preterm birth in women with preterm labour. Design Multicentre, randomised, double‐blind, placebo‐controlled trial. Setting Twenty‐nine centres in Switzerland and Argentina. Population A total of 385 women with preterm labour (240/7 to 336/7 weeks of gestation) treated with acute tocolysis. Methods Participants were randomly allocated to either 200 mg daily of self‐administered vaginal progesterone or placebo within 48 hours of starting acute tocolysis. Main outcome measures Primary outcome was delivery before 37 weeks of gestation. Secondary outcomes were delivery before 32 and 34 weeks, adverse effects, duration of tocolysis, re‐admissions for preterm labour, length of hospital stay, and neonatal morbidity and mortality. The study was ended prematurely based on results of the intermediate analysis. Results Preterm birth occurred in 42.5% of women in the progesterone group versus 35.5% in the placebo group (relative risk [RR] 1.2; 95% confidence interval [95% CI] 0.93–1.5). Delivery at <32 and <34 weeks did not differ between the two groups (12.9 versus 9.7%; [RR 1.3; 95% CI 0.7–2.5] and 19.7 versus 12.9% [RR 1.5; 95% CI 0.9–2.4], respectively). The duration of tocolysis, hospitalisation, and recurrence of preterm labour were comparable between groups. Neonatal morbidity occurred in 44 (22.8%) cases on progesterone versus 35 (18.8%) cases on placebo (RR: 1.2; 95% CI 0.82–1.8), whereas there were 4 (2%) neonatal deaths in each study group. Conclusion There is no evidence that the daily administration of 200 mg vaginal progesterone decreases preterm birth or improves neonatal outcome in women with preterm labour.
Bibliography:	http://dx.doi.org/10.1111/1471-0528.13108 This article is commented on by ER Norwitz, p. 92 in this issue. To view this mini commentary visit Linked article The article has journal club questions by EYL Leung, p. 93 in this issue. To view these visit . http://dx.doi.org/10.1111/1471-0528.13196 ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-News-1 ObjectType-Feature-3 content type line 23 ObjectType-Evidence Based Healthcare-3 ObjectType-Feature-1
ISSN:	1470-0328 1471-0528
DOI:	10.1111/1471-0528.13061