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ISRCTN
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ISRCTN82417627
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ClinicalTrials.gov identifier
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NCT00070720
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Public title
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Improving perinatal care in Latin America
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Scientific title
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Acronym
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GUIDELINES Trial
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Serial number at source
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GN 01
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Study hypothesis
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The aim of this trial is to evaluate the effect of a multifaceted behavioural intervention on the use of two evidence-based birth practices, the selective use of episiotomies and active management of the third stage of labor (injection of 10 International Units of oxytocin).
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Ethics approval
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The protocol was submitted and approved by the IRBs of the following institutions:
1. University of North Carolina at Chapel Hill (USA)
2. Tulane University (USA)
3. Research Triangle Institute (USA)
4. Pan American Health Organization (USA)
5. School of Medicine of the University of the Republic in Uruguay (Uruguay)
6. The University Hospital of Montevideo (Uruguay)
7. The Argentinean Society for Clinical Research (Argentina)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Argentina, Uruguay
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Disease/condition/study domain
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Episiotomy use; post-partum haemorrhage
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Participants - inclusion criteria
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24 public hospitals in Argentina and Uruguay that had:
1. At least 1000 vaginal deliveries per year
2. No explicit policy for selective episiotomy or active management of third stage of labor
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Participants - exclusion criteria
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Does not comply with above inclusion criteria.
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Anticipated start date
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01/09/2003
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Anticipated end date
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01/09/2006
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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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24
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Interventions
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Intervention group:
Evidence based clinical practice guidelines development workshop for opinion leaders. Opinion leaders will then use academic detailing, reminders, and feedback for dissemination and implementation of guidelines at the hospital level.
Control group:
Control hospitals will continue with their usual in-service training activities and will receive components of the intervention at the end of the study period.
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Primary outcome measure(s)
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The rates of episiotomy and oxytocin use during the third stage of labor.
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Secondary outcome measure(s)
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1. Perineal sutures
2. Postpartum haemorrhages
3. Birth attendants opinions
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Sources of funding
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1. National Institute of Child Health and Human Development (NICHD) (USA)
2. Global Network for Women's and Children's Health Research (USA)
3. Bill and Melinda Gates Foundation (USA)
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Trial website
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Publications
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Protocol in http://www.ncbi.nlm.nih.gov/pubmed/15823211
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Contact name
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Dr
Pierre
Buekens
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Address
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School of Public Health and Tropical Medicine
Tulane University
1440 Canal St
Ste 2430
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City/town
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New Orleans, LA
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Zip/Postcode
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70112
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Country
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United States of America
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Tel
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+1 504 988 5397
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Fax
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+1 504 988 5718
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Email
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pbuekens@tulane.edu
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Sponsor
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National Institute of Child Health and Human Development (NICHD) (USA)
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Address
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6100 Executive Boulevard
Room 4B05H
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City/town
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Rockville, MD
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Zip/Postcode
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20852
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Country
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United States of America
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Tel
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+1 301 402 0830
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Fax
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+1 301 480 7773
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Email
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wrightl@mail.nih.gov
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Date applied
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04/11/2004
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Last edited
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18/02/2008
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Date ISRCTN assigned
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25/02/2005
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