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Double blind randomised placebo controlled trial of progesterone for the prevention of preterm birth in twins
DOI 10.1186/ISRCTN35782581
ClinicalTrials.gov identifier
EudraCT number
Public title Double blind randomised placebo controlled trial of progesterone for the prevention of preterm birth in twins
Scientific title
Serial number at source RN04OB007
Study hypothesis Vaginal progesterone gel, 90 mg daily from 24-34 weeks gestation, reduces the rate of preterm delivery in twin pregnancy.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Preterm delivery
Participants - inclusion criteria 1. Women with twin pregnancy
2. Gestation established by scan before 20 weeks gestation
3. Known chorionicity
Participants - exclusion criteria 1. Known signficiant structural or chromosomal fetal abnormality
2. Contraindications to progesterone
3. Planned cervical suture
4. Planned elective delivery before 34 weeks gestation
5. Intervention for twin to twin transfusion before 22 weeks
Anticipated start date 01/11/2005
Anticipated end date 30/10/2008
Status of trial Completed
Patient information material Patient information can be found at: https://medserv.abdn.ac.uk/stoppit/pis.php
Target number of participants 500
Interventions Vaginal progesterone, 90 mg daily for ten weeks from 24 weeks gestation versus placebo
Primary outcome measure(s) Proportion of women in each group delivering before 34 weeks gestation
Secondary outcome measure(s) Pregnancy duration, maternal complication rates, neonatal complication rates, maternal side effects, acceptability of treatment, subject perception of alternatives, perinatal mortality, perinatal morbidity
Sources of funding Chief Scientist's Office, Scottish Executive (ref no CZH/4/200) (UK)
Trial website https://medserv.abdn.ac.uk/stoppit/index.php
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19523680
Contact name Dr  Jane  Norman
  Address University of Glasgow Division of Developmental Medicine
4th Floor, Queen Elizabeth Building
Glasgow Royal Infirmary
10 Alexandra Parade
  City/town Glasgow
  Zip/Postcode G31 2ER
  Country United Kingdom
  Tel +44 (0)141 211 4708
  Fax +44 (0)141 553 1367
  Email j.e.norman@clinmed.gla.ac.uk
Sponsor Greater Glasgow Health Board (North Glasgow University Hospitals Division) and the University of Glasgow (UK)
  Address Research and Development Office
4th Floor, Walton Building
Glasgow Royal Infirmary
84 Castle Street
  City/town Glasgow
  Zip/Postcode G4 OSF
  Country United Kingdom
  Tel +44 (0)141 211 0475
  Fax +44 (0)141 232 0752
  Email fiona.graham.gri@northglasgow.scot.nhs.uk
Date applied 10/06/2005
Last edited 18/06/2009
Date ISRCTN assigned 25/07/2005
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