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

Schuit, E and Stock, S and Groenwold, RHH and Maurel, K and Combs, CA and Garite, T and Spong, CY and Thom, EA and Rouse, DJ and Caritis, SN and Saade, GR and Zachary, JM and Norman, JE and Rode, L and Klein, K and Tabor, A and Çetingöz, E and Morrison, JC and Magann, EF and Briery, CM and Serra, V and Perales, A and Meseguer, J and Nassar, AH and Lim, AC and Moons, KGM and Kwee, A and Mol, BWJ (2012) Progestogens to prevent preterm birth in twin pregnancies: An individual participant data meta-analysis of randomized trials. BMC Pregnancy and Childbirth, 12.

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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. © 2012 Schuit et al; licensee BioMed Central Ltd.

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Details

Item Type: Article
Status: Published
Creators/Authors:
CreatorsEmailPitt UsernameORCID
Schuit, E
Stock, S
Groenwold, RHH
Maurel, K
Combs, CA
Garite, T
Spong, CY
Thom, EA
Rouse, DJ
Caritis, SNcaritiss@pitt.eduCARITISS
Saade, GR
Zachary, JM
Norman, JE
Rode, L
Klein, K
Tabor, A
Çetingöz, E
Morrison, JC
Magann, EF
Briery, CM
Serra, V
Perales, A
Meseguer, J
Nassar, AH
Lim, AC
Moons, KGM
Kwee, A
Mol, BWJ
Centers: Other Centers, Institutes, Offices, or Units > Magee-Women's Research Institute
Date: 15 March 2012
Date Type: Publication
Journal or Publication Title: BMC Pregnancy and Childbirth
Volume: 12
DOI or Unique Handle: 10.1186/1471-2393-12-13
Schools and Programs: School of Medicine > Obstetrics, Gynecology, and Reproductive Sciences
Refereed: Yes
Date Deposited: 20 Oct 2016 18:22
Last Modified: 02 Feb 2019 14:55
URI: http://d-scholarship.pitt.edu/id/eprint/29943

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