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Open Access Study protocol

Trial protocol OPPTIMUM– Does progesterone prophylaxis for the prevention of preterm labour improve outcome?

Jane E Norman1*, Andrew Shennan2, Phillip Bennett3, Steven Thornton4, Stephen Robson5, Neil Marlow6, John Norrie7, Stavros Petrou8, Neil Sebire9, Tina Lavender10 and Sonia Whyte11

Author affiliations

1 University of Edinburgh MRC Centre for Reproductive Health, The Queen’s Medical Research Institute, 47 Little France Crescent, Edinburgh, EH16 4TY, UK

2 Women's Health Academic Centre, King’s Health Partners, 10th floor North Wing, St.Thomas' Hospital, London, SE1 7EH, UK

3 Imperial College Faculty of Medicine, Institute for Reproductive and Developmental Biology, Hammersmith Hospital Campus, Du Cane Road, London, W12 0NN, UK

4 Peninsula College of Medicine and Dentistry, Peninsula Medical School, Barrack Road, Exeter, EX2 5DW, UK

5 Institute of Cellular Medicine, Uterine Cell Signalling Group, 3rd Floor, William Leech Building, The Medical School, Newcastle University, Newcastle, NE2 4HH, UK

6 Institute for Women’s Health, University College London, Room 244, Medical School Building, 74 Huntley Street, London, WC1E 6AU, UK

7 Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, 3rd Floor Health Sciences Building, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK

8 University of Warwick Division of Health Sciences, Warwick Medical School, The University of Warwick, Coventry, CV4 7AL, UK

9 Histopathology Department, Department of Paediatric Laboratory Medicine, Level 3, Camelia Botnar Laboratories, Great Ormond Street Hospital, London, WC1N 3JH, UK

10 School of Nursing, Midwifery and Social Work, The University of Manchester, Manchester, UK

11 University of Edinburgh MRC Centre for Reproductive Health, c/o Simpson Centre for Reproductive Health, Royal Infirmary, 51 Little France Crescent, Edinburgh, EH16 4SA, UK

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Citation and License

BMC Pregnancy and Childbirth 2012, 12:79  doi:10.1186/1471-2393-12-79

Published: 6 August 2012

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.

Trial registration

ISRCTN14568373