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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, N. 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. ISSN 1471-2393

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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

Subjects:

R Medicine > RG Gynecology and obstetrics

Divisions:

Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School

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:

Date	Event
2012	Published

Volume:

Vol.12

Number:

No.1

Page Range:

p. 79

Identification Number:

10.1186/1471-2393-12-79

Status:

Peer Reviewed

Publication Status:

Published

Access rights to Published version:

Open Access

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