Condition category
Pregnancy and Childbirth
Date applied
04/11/2004
Date assigned
25/02/2005
Last edited
10/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes