Study protocol

BMC Pregnancy and Childbirth

, 12:79

Open Access This content is freely available online to anyone, anywhere at any time.

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

  • Jane E NormanAffiliated withUniversity of Edinburgh MRC Centre for Reproductive Health, The Queen’s Medical Research Institute Email author 
  • , Andrew ShennanAffiliated withWomen’s Health Academic Centre, King’s Health Partners, 10th floor North Wing, St.Thomas’ Hospital
  • , Phillip BennettAffiliated withImperial College Faculty of Medicine, Institute for Reproductive and Developmental Biology, Hammersmith Hospital Campus
  • , Steven ThorntonAffiliated withPeninsula College of Medicine and Dentistry, Peninsula Medical School
  • , Stephen RobsonAffiliated withInstitute of Cellular Medicine, Uterine Cell Signalling Group, 3rd Floor, William Leech Building, The Medical School, Newcastle University
  • , Neil MarlowAffiliated withInstitute for Women’s Health, University College London, Room 244, Medical School Building
  • , John NorrieAffiliated withCentre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, 3rd Floor Health Sciences Building, University of Aberdeen
  • , Stavros PetrouAffiliated withUniversity of Warwick Division of Health Sciences, Warwick Medical School, The University of Warwick
  • , Neil SebireAffiliated withHistopathology Department, Department of Paediatric Laboratory Medicine, Level 3, Camelia Botnar Laboratories, Great Ormond Street Hospital
    • , Tina LavenderAffiliated withSchool of Nursing, Midwifery and Social Work, The University of Manchester
    • , Sonia WhyteAffiliated withUniversity of Edinburgh MRC Centre for Reproductive Health, c/o Simpson Centre for Reproductive Health, Royal Infirmary

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