Contact information
Type
Scientific
Primary contact
Dr Pierre Buekens
ORCID ID
Contact details
School of Public Health and Tropical Medicine
Tulane University
1440 Canal St
Ste 2430
New Orleans
LA
70112
United States of America
+1 504 988 5397
pbuekens@tulane.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00070720
Protocol/serial number
GN 01
Study information
Scientific title
Acronym
GUIDELINES Trial
Study hypothesis
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).
Ethics approval
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)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Episiotomy use; post-partum haemorrhage
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Oxytocin
Primary outcome measures
The rates of episiotomy and oxytocin use during the third stage of labor.
Secondary outcome measures
1. Perineal sutures
2. Postpartum haemorrhages
3. Birth attendants opinions
Overall trial start date
01/09/2003
Overall trial end date
01/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
24 public hospitals
Participant exclusion criteria
Does not comply with above inclusion criteria.
Recruitment start date
01/09/2003
Recruitment end date
01/09/2006
Locations
Countries of recruitment
Argentina, Uruguay
Trial participating centre
School of Public Health and Tropical Medicine
New Orleans, LA
70112
United States of America
Sponsor information
Organisation
National Institute of Child Health and Human Development (NICHD) (USA)
Sponsor details
6100 Executive Boulevard
Room 4B05H
Rockville
MD
20852
United States of America
+1 301 402 0830
wrightl@mail.nih.gov
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute of Child Health and Human Development (NICHD) (USA)
Alternative name(s)
NICHD
Funding Body Type
government organisation
Funding Body Subtype
federal/national government
Location
United States of America
Funder name
Global Network for Women's and Children's Health Research (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Bill and Melinda Gates Foundation (USA)
Alternative name(s)
Bill & Melinda Gates Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2005 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/15823211
Publication citations
-
Protocol
Althabe F, Buekens P, Bergel E, Belizán JM, Kropp N, Wright L, Goco N, Moss N, , A cluster randomized controlled trial of a behavioral intervention to facilitate the development and implementation of clinical practice guidelines in Latin American maternity hospitals: the Guidelines Trial: Study protocol [ISRCTN82417627]., BMC Womens Health, 2005, 5, 1, 4, doi: 10.1186/1472-6874-5-4.