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Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study) : a multicentre, randomised, double-blind trial
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Norman, Jane Elizabeth, Marlow, Neil, Messow, Claudia-Martina, Shennan, Andrew, Bennett, Phillip R., Thornton, Steven, Robson, Stephen C., McConnachie, Alex, Petrou, Stavros, Sebire, Neil J., Lavender, Tina, Whyte, Sonia and Norrie, John (2016) Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study) : a multicentre, randomised, double-blind trial. The Lancet, 387 (10033). pp. 2106-2116. doi:10.1016/S0140-6736(16)00350-0
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Official URL: http://dx.doi.org/10.1016/S0140-6736(16)00350-0
Abstract
Summary
Background
Progesterone 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.
Methods
We 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.
Findings
Between 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 multiple outcomes, progesterone had no significant effect on the primary obstetric outcome (odds ratio adjusted for multiple comparisons [OR] 0·86, 95% CI 0·61–1·22) or neonatal outcome (OR 0·62, 0·38–1·03), nor on the childhood outcome (cognitive score, progesterone group vs placebo group, 97·3 [SD 17·9] vs 97·7 [17·5]; difference in means −0·48, 95% CI −2·77 to 1·81). Maternal or child serious adverse events were reported in 70 (11%) of 610 patients in the placebo group and 59 (10%) of 616 patients in the progesterone group (p=0·27).
| Item Type: | Journal Article | ||||||
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| Subjects: | R Medicine > RG Gynecology and obstetrics R Medicine > RJ Pediatrics |
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| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Progesterone -- Therapeutic use , Women -- Pregnancy, Premature infants, Newborn infants -- Death, Infants | ||||||
| Journal or Publication Title: | The Lancet | ||||||
| Publisher: | Lancet Publishing Group | ||||||
| ISSN: | 0140-6736 | ||||||
| Official Date: | 1 May 2016 | ||||||
| Dates: |
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| Volume: | 387 | ||||||
| Number: | 10033 | ||||||
| Page Range: | pp. 2106-2116 | ||||||
| DOI: | 10.1016/S0140-6736(16)00350-0 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access | ||||||
| Funder: | Medical Research Council (Great Britain) (MRC), National Institute for Health Research (Great Britain) (NIHR) | ||||||
| Grant number: | Efficacy and Mechanism Evaluation (EME) Programme |
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