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ISRCTN
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ISRCTN31614268
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ClinicalTrials.gov identifier
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Public title
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Randomised, double-blinded placebo controlled trial of the use of tocolysis for a repeat external cephalic version after a failed version for breech presentation at term
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Scientific title
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Acronym
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N/A
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Serial number at source
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SEO093
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Study hypothesis
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To determine the optimum protocol for performing external cephalic version for breech presentation at term. Null hypothesis: that tocolysis for a repeat external cephalic version (ECV) after a failed ECV does not increase the success rates of ECV
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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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Childbirth
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Participants - inclusion criteria
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1. Women with suspected or confirmed breech presentation at >36 weeks gestation
2. Have undergone a single (<15 mins) unsuccessful attempt at external cephalic version without tocolysis at 37 or more weeks' gestation
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Participants - exclusion criteria
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1. Abnormal cardiotocograph
2. Cardiac disease
3. Pre-existing or gestational diabetes
4. Hypertension;
5. Pre-existing indication for caesarian section
6. Suspected unstable lie
7. Pre-eclampsia
8. recent (<4 weeks) antepartum haemorrhage
9. suspected fetal compromise
10. rhesus immunisation
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Anticipated start date
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06/04/2000
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Anticipated end date
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06/04/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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124 (added 12/01/10, see publication)
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Interventions
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1. 50 mg ritodrine hydrochloride infusion
2. 17 ml dextrose saline solution infusion
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Primary outcome measure(s)
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1. Incidence of cephalic presentation at delivery
2. Subjective patient assessment of discomfort
3. Incidence of caesarian section
4. Length of hospital stay
5. Incidence of neonatal Apgar scores <7 at 5 minutes
6. Incidence of neonatal intensive care admission
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NHS Executive South East (UK)
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Trial website
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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15842288
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Contact name
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Mr
Lawrence
Impey
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Address
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Level 4
The Women's Centre
John Radcliffe Hospital
Headley Way
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 9DU
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Country
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United Kingdom
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Tel
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+44 (0)1865741166 Ex 21408/21624
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Email
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LWMI@compuserve.com
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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12/01/2010
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Date ISRCTN assigned
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23/01/2004
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