ISRCTN ISRCTN82417627
DOI https://doi.org/10.1186/ISRCTN82417627
ClinicalTrials.gov number NCT00070720
Secondary identifying numbers GN 01
Submission date
04/11/2004
Registration date
25/02/2005
Last edited
28/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Pierre Buekens
Scientific

School of Public Health and Tropical Medicine
Tulane University
1440 Canal St
Ste 2430
New Orleans, LA
70112
United States of America

Phone +1 504 988 5397
Email pbuekens@tulane.edu

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA behavioral intervention to improve obstetrical care.
Study acronymGUIDELINES Trial
Study objectivesThe 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(s)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)
Health condition(s) or problem(s) studiedEpisiotomy use; post-partum haemorrhage
InterventionIntervention 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Oxytocin
Primary outcome measureThe rates of episiotomy and oxytocin use during the third stage of labor.
Secondary outcome measures1. Perineal sutures
2. Postpartum haemorrhages
3. Birth attendants opinions
Overall study start date01/09/2003
Completion date01/09/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants24 public hospitals
Key inclusion criteria24 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
Key exclusion criteriaDoes not comply with above inclusion criteria.
Date of first enrolment01/09/2003
Date of final enrolment01/09/2006

Locations

Countries of recruitment

  • Argentina
  • United States of America
  • Uruguay

Study participating centre

School of Public Health and Tropical Medicine
New Orleans, LA
70112
United States of America

Sponsor information

National Institute of Child Health and Human Development (NICHD) (USA)
Government

6100 Executive Boulevard
Room 4B05H
Rockville, MD
20852
United States of America

Phone +1 301 402 0830
Email wrightl@mail.nih.gov
ROR logo "ROR" https://ror.org/04byxyr05

Funders

Funder type

Government

National Institute of Child Health and Human Development (NICHD) (USA)
Government organisation / National government
Alternative name(s)
NICHD
Location
United States of America
Global Network for Women's and Children's Health Research (USA)

No information available

Bill and Melinda Gates Foundation (USA)
Government organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 11/04/2005 Yes No
Results article results 01/05/2008 28/01/2019 Yes No

Editorial Notes

28/01/2019: Publication reference added