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Does progesterone prophylaxis to prevent preterm labour improve outcome?: a randomised, double-blind, placebo-controlled trial
DOI 10.1186/ISRCTN14568373
ClinicalTrials.gov identifier
EudraCT number
Public title Does progesterone prophylaxis to prevent preterm labour improve outcome?: a randomised, double-blind, placebo-controlled trial
Scientific title
Serial number at source MRC ref: G0700452
Study hypothesis Primary objective: In women at high risk of preterm labour, does prophylactic vaginal natural progesterone, 200 mg daily from 22-34 weeks gestation, compared to placebo:
1. Improve obstetric outcome by lengthening pregnancy and thus reducing the incidence of preterm delivery (before 34 weeks gestation)?
2. Improve neonatal outcome by reducing a composite of death and major morbidity?
3. Lead to improved childhood cognitive and neurosensory outcomes at two years?
4. Represent cost effective management for women at high risk of preterm delivery?

More details can be found at: http://www.mrc.ac.uk/ResearchPortfolio/Grant/Record.htm?GrantRef=G0700452&CaseId=9676

Please note that as of 08/04/2013, the end date for this trial was updated from 31/01/2014 to 31/12/2015
Lay summary Lay summary under review 3
Ethics approval Scotland MREC A, approved on 19/02/2008 (ref: 08/MRE00/6)
Study design Randomised double-blind placebo-controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Preterm labour
Participants - inclusion criteria Screening Study:
High risk for preterm birth as indicated by at least one of the following:
1. History of previous preterm birth (PTB)/second trimester loss
2. Previous preterm premature rupture of the foetal membranes
3. Short cervical length (<25 mm) on ultrasound at 18-22 weeks gestation
4. All women will have gestation established by scan at ¡Ü 16 weeks to ensure that the estimated date of delivery is accurate
5. Signed consent form

Main Study:
All women fulfilling the above inclusion criteria and who have a positive screening (fFN) test at 22 weeks will be eligible for the main (treatment) phase of the study. Further consent must be obtained.
Participants - exclusion criteria 1. Known significant structural or chromosomal foetal anomaly
2. Known sensitivity, contraindication or intolerance to progesterone (including peanut allergy)
3. Suspected or proven rupture of the foetal membranes at the time of recruitment
4. Multiple pregnancy
5. Prescription or ingestion of medications known to interact with progesterone (e.g., ketoconazole and ciclosporin)
Anticipated start date 01/10/2008
Anticipated end date 31/12/2015
Status of trial Ongoing
Patient information material Patient information sheet can be found at: http://www.opptimum.org.uk/general-information.aspx
Target number of participants Screening phase: 8320; treatment phase: 750
Interventions Prophylactic vaginal natural progesterone, 200 mg daily from 22-24 weeks gestation until 34 weeks gestation vs placebo.
Primary outcome measure(s) 1. Primary obstetric outcome of the treatment phase is delivery <34 weeks of gestation (Yes/No)
2. Primary neonatal outcome is a composite of death or two markers of neonatal morbidity
3. Primary childhood outcome is developmental status at two years
4. Formal economic evaluation
Secondary outcome measure(s) 1. Gestational age at delivery
2. Death after trial entry or severe disability at two years of age
3. Incidence of the individual components of the primary neonatal outcome
4. Incidence of other major neonatal complications: need for and duration of respiratory support, surfactant administration, duration of oxygen therapy, necrotising enterocolitis, number of discrete episodes of infection (e.g., positive blood culture, cerebrospinal fluid [CSF] culture), daily level of care
5. Composite outcome of death or neurodevelopmental impairment at two years of age, the latter defined as one or more of:
5.1. Disabling cerebral palsy, defined as a score of 2 or higher on the Gross Motor Function Classification System, or 3 or higher on the Manual Ability Classification System, plus classified using the SCPE system
5.2. Developmental impairment (Cognitive standardised score <70)
5.3. Severe visual loss (legally certifiable as blind or partially sighted)
5.4. Profound/severe deafness (requiring hearing aids). Disability will be classified into domains according to professional consensus.
5.5. Brief Infant Toddler Social Emotional Assessment (BITSEA)
5.6. Women's perceptions of treatment
5.7. Maternal and child adverse events (e.g., operative delivery)
Sources of funding Medical Research Council (UK) (grant ref: G0700452)
Trial website http://www.opptimum.org.uk
Publications 1. 2010 questionnaire results in http://www.ncbi.nlm.nih.gov/pubmed/21122602
2. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22866909
Contact name Prof  Jane  Norman
  Address Chair of Maternal and Foetal Health
University of Edinburgh
Centre for Reproductive Biology
The Queens Medical Research Institute
47 Little France Crescent
  City/town Edinburgh
  Zip/Postcode EH16 4TJ
  Country United Kingdom
  Tel +44 (0)131 242 2694
  Email jane.norman@ed.ac.uk
Sponsor University of Edinburgh (UK)
  Address Edinburgh Clinical Trials Unit
The Queen's Medical Research Institute
47 Little France Crescent
  City/town Edinburgh
  Zip/Postcode EH16 4TJ
  Country United Kingdom
  Tel +44 (0)131 242 9461
  Email e.currie@ed.ac.uk
  Sponsor website: http://www.ed.ac.uk
Date applied 29/08/2008
Last edited 09/05/2013
Date ISRCTN assigned 21/11/2008
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