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