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Trial protocol OPPTIMUM : does progesterone prophylaxis for the prevention of preterm labour improve outcome?
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Norman, Jane E., Shennan, Andrew, Bennett, Phillip R., Thornton, Steven, Robson, Stephen, Marlow, Neil, Norrie, John, Petrou, Stavros, Sebire, Neil J., Lavender, Tina and Whyte, Sonia (2012) Trial protocol OPPTIMUM : does progesterone prophylaxis for the prevention of preterm labour improve outcome? BMC Pregnancy and Childbirth, Vol.12 (No.1). p. 79. doi:10.1186/1471-2393-12-79
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Official URL: http://dx.doi.org/10.1186/1471-2393-12-79
Abstract
Background
Preterm birth is a global problem, with a prevalence of 8 to 12% depending on location. Several large trials and systematic reviews have shown progestogens to be effective in preventing or delaying preterm birth in selected high risk women with a singleton pregnancy (including those with a short cervix or previous preterm birth). Although an improvement in short term neonatal outcomes has been shown in some trials these have not consistently been confirmed in meta-analyses. Additionally data on longer term outcomes is limited to a single trial where no difference in outcomes was demonstrated at four years of age of the child, despite those in the “progesterone” group having a lower incidence of preterm birth.
Methods/Design
The OPPTIMUM study is a double blind randomized placebo controlled trial to determine whether progesterone prophylaxis to prevent preterm birth has long term neonatal or infant benefit. Specifically it will study whether, in women with singleton pregnancy and at high risk of preterm labour, prophylactic vaginal natural progesterone, 200 mg daily from 22 – 34 weeks gestation, compared to placebo, improves obstetric outcome by lengthening pregnancy thus reducing the incidence of preterm delivery (before 34 weeks), improves neonatal outcome by reducing a composite of death and major morbidity, and leads to improved childhood cognitive and neurosensory outcomes at two years of age. Recruitment began in 2009 and is scheduled to close in Spring 2013. As of May 2012, over 800 women had been randomized in 60 sites.
Discussion
OPPTIMUM will provide further evidence on the effectiveness of vaginal progesterone for prevention of preterm birth and improvement of neonatal outcomes in selected groups of women with singleton pregnancy at high risk of preterm birth. Additionally it will determine whether any reduction in the incidence of preterm birth is accompanied by improved childhood outcome.
| Item Type: | Journal Article | ||||
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| Subjects: | R Medicine > RG Gynecology and obstetrics | ||||
| 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): | Premature labor -- Prevention, Progestational hormones | ||||
| Journal or Publication Title: | BMC Pregnancy and Childbirth | ||||
| Publisher: | BioMed Central Ltd. | ||||
| ISSN: | 1471-2393 | ||||
| Official Date: | 2012 | ||||
| Dates: |
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| Date of first compliant deposit: | 23 December 2015 | ||||
| Volume: | Vol.12 | ||||
| Number: | No.1 | ||||
| Page Range: | p. 79 | ||||
| DOI: | 10.1186/1471-2393-12-79 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Open Access |
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