Progestogens to prevent preterm birth in twin pregnancies: an individual participant data meta-analysis of randomized trials

Autor: Schuit Ewoud, Stock Sarah, Groenwold Rolf HH, Maurel Kimberly, Combs C Andrew, Garite Thomas, Spong Cathy Y, Thom Elizabeth A, Rouse Dwight J, Caritis Steve N, Saade George R, Zachary Julia M, Norman Jane E, Rode Line, Klein Katharina, Tabor Ann, Çetingöz Elçin, Morrison John C, Magann Everett F, Briery Christian M, Serra Vicente, Perales Alfredo, Meseguer Juan, Nassar Anwar H, Lim Arianne C, Moons Karel GM, Kwee Anneke, Mol Ben Willem J
Jazyk: angličtina
Rok vydání: 2012
Předmět:
Zdroj: BMC Pregnancy and Childbirth, Vol 12, Iss 1, p 13 (2012)
Druh dokumentu: article
ISSN: 1471-2393
45089841
DOI: 10.1186/1471-2393-12-13
Popis: Abstract Background Preterm birth is the principal factor contributing to adverse outcomes in multiple pregnancies. Randomized controlled trials of progestogens to prevent preterm birth in twin pregnancies have shown no clear benefits. However, individual studies have not had sufficient power to evaluate potential benefits in women at particular high risk of early delivery (for example, women with a previous preterm birth or short cervix) or to determine adverse effects for rare outcomes such as intrauterine death. Methods/design We propose an individual participant data meta-analysis of high quality randomized, double-blind, placebo-controlled trials of progestogen treatment in women with a twin pregnancy. The primary outcome will be adverse perinatal outcome (a composite measure of perinatal mortality and significant neonatal morbidity). Missing data will be imputed within each original study, before data of the individual studies are pooled. The effects of 17-hydroxyprogesterone caproate or vaginal progesterone treatment in women with twin pregnancies will be estimated by means of a random effects log-binomial model. Analyses will be adjusted for variables used in stratified randomization as appropriate. Pre-specified subgroup analysis will be performed to explore the effect of progestogen treatment in high-risk groups. Discussion Combining individual patient data from different randomized trials has potential to provide valuable, clinically useful information regarding the benefits and potential harms of progestogens in women with twin pregnancy overall and in relevant subgroups.
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