Imperial College London
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ProfessorPhillipBennett

Faculty of Medicine, Department of Metabolism, Digestion and Reproduction

Clinical Professor
 
 
 
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Contact

 

+44 (0)20 7594 2176p.bennett

 
 
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Assistant

 

Miss Kiran Dosanjh +44 (0)20 7594 2176

 
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Location

 

Hammersmith HospitalHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Norman:2016:10.1016/S0140-6736(16)00350-0,
author = {Norman, JE and Marlow, N and Messow, CM and Shennan, A and Bennett, PR and Thornton, S and Robson, SC and McConnachie, A and Petrou, S and Sebire, NJ and Lavender, T and Whyte, S and Norrie, J and OPPTIMUM, study group},
doi = {10.1016/S0140-6736(16)00350-0},
journal = {The Lancet},
pages = {2106--2116},
title = {Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study): a multicentre, randomised, double-blind trial},
url = {http://dx.doi.org/10.1016/S0140-6736(16)00350-0},
volume = {387},
year = {2016}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BackgroundProgesterone administration has been shown to reduce the risk of preterm birth and neonatal morbidity in women at high risk, but there is uncertainty about longer term effects on the child.MethodsWe did a double-blind, randomised, placebo-controlled trial of vaginal progesterone, 200 mg daily taken from 22–24 to 34 weeks of gestation, on pregnancy and infant outcomes in women at risk of preterm birth (because of previous spontaneous birth at ≤34 weeks and 0 days of gestation, or a cervical length ≤25 mm, or because of a positive fetal fibronectin test combined with other clinical risk factors for preterm birth [any one of a history in a previous pregnancy of preterm birth, second trimester loss, preterm premature fetal membrane rupture, or a history of a cervical procedure to treat abnormal smears]). The objective of the study was to determine whether vaginal progesterone prophylaxis given to reduce the risk of preterm birth affects neonatal and childhood outcomes. We defined three primary outcomes: fetal death or birth before 34 weeks and 0 days gestation (obstetric), a composite of death, brain injury, or bronchopulmonary dysplasia (neonatal), and a standardised cognitive score at 2 years of age (childhood), imputing values for deaths. Randomisation was done through a web portal, with participants, investigators, and others involved in giving the intervention, assessing outcomes, or analysing data masked to treatment allocation until the end of the study. Analysis was by intention to treat. This trial is registered at ISRCTN.com, number ISRCTN14568373.FindingsBetween Feb 2, 2009, and April 12, 2013, we randomly assigned 1228 women to the placebo group (n=610) and the progesterone group (n=618). In the placebo group, data from 597, 587, and 439 women or babies were available for analysis of obstetric, neonatal, and childhood outcomes, respectively; in the progesterone group the corresponding numbers were 600, 589, and 430. After correction for
AU  - Norman,JE
AU  - Marlow,N
AU  - Messow,CM
AU  - Shennan,A
AU  - Bennett,PR
AU  - Thornton,S
AU  - Robson,SC
AU  - McConnachie,A
AU  - Petrou,S
AU  - Sebire,NJ
AU  - Lavender,T
AU  - Whyte,S
AU  - Norrie,J
AU  - OPPTIMUM,study group
DO  - 10.1016/S0140-6736(16)00350-0
EP  - 2116
PY  - 2016///
SN  - 0140-6736
SP  - 2106
TI  - Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study): a multicentre, randomised, double-blind trial
T2  - The Lancet
UR  - http://dx.doi.org/10.1016/S0140-6736(16)00350-0
UR  - https://www.sciencedirect.com/science/article/pii/S0140673616003500?via%3Dihub
UR  - http://hdl.handle.net/10044/1/31789
VL  - 387
ER  -
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