Improving perinatal care in Latin America

ISRCTN	ISRCTN82417627
DOI	https://doi.org/10.1186/ISRCTN82417627
ClinicalTrials.gov (NCT)	NCT00070720
Protocol serial number	GN 01
Sponsor	National Institute of Child Health and Human Development (NICHD) (USA)
Funders	National Institute of Child Health and Human Development (NICHD) (USA), Global Network for Women's and Children's Health Research (USA), Bill and Melinda Gates Foundation (USA)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A behavioral intervention to improve obstetrical care.
Study acronym	GUIDELINES Trial
Study objectives	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(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) studied	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 / device / biological / vaccine name(s)	Oxytocin
Primary outcome measure(s)	The rates of episiotomy and oxytocin use during the third stage of labor.
Key secondary outcome measure(s)	1. Perineal sutures 2. Postpartum haemorrhages 3. Birth attendants opinions
Completion date	01/09/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	24
Key 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
Key exclusion criteria	Does not comply with above inclusion criteria.
Date of first enrolment	01/09/2003
Date of final enrolment	01/09/2006

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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

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

Editorial Notes

28/01/2019: Publication reference added