NCT00070720

Brief Summary

Many obstetrical interventions used in Latin America, as in other parts of the world, have been shown to be ineffective or harmful, while effective interventions remain underutilized. This study will develop and evaluate an intervention intended to implement two evidence-based practices among birth attendants in Latin America, the selective use of episiotomies and active management of the third stage of labor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21,780

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2003

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 13, 2003

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

December 17, 2013

Status Verified

December 1, 2013

First QC Date

October 7, 2003

Last Update Submit

December 16, 2013

Conditions

EpisiotomyPregnancy

Keywords

Behavior changeChange in practitioner behaviorEpisiotomyActive management of third stage of laborGlobal NetworkLatin AmericaUruguayArgentinaMaternal and child healthInternationalWomen's health

Outcome Measures

Primary Outcomes (2)

  • Episiotomies

  • Oxytocin use in third stage of labor

Secondary Outcomes (3)

  • Perineal sutures

  • Postpartum hemorrhage

  • Birth attendants' readiness to change status

Interventions

Opinion Leaders, Academic Detailing, Reminders, and FeedbackBEHAVIORAL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitals were invited to participate in the study if they fulfill the following criteria:
  • have an Institutional Review Board (IRB), or existing committee which could serve as such, or have an agreement with an IRB which reviews the research protocols implemented in the hospital;
  • have at least 500 vaginal deliveries per year;
  • do not have an explicit policy for selective episiotomy and for active management of third stage of labor;
  • are located within the study area in Argentina and Uruguay; and
  • agree to participate in the study.

You may not qualify if:

  • Preselected hospitals are performing baseline data collection. According to the results of the analysis of the baseline data collection, hospitals will be excluded if the episiotomy rate is low or the rate of active management of the third stage of labor is high, according to the following cut-off points:
  • Episiotomy rate in spontaneous vaginal deliveries below 20%
  • Rate of active management of third stage of labor over 25%
  • Expectant management is defined as "a hands-free policy" during third stage of labor until the placenta is expelled: no use of uterotonics or special maneuvers.
  • Sampling, Recruitment, and Screening Procedures
  • Latin American Center for Perinatology (CLAP) coordination team will be responsible for the hospital selection. The hospitals' fulfillment of selection criteria will be obtained through a survey of the Heads of the Obstetrical Departments.
  • Besides the selection criteria, the coordination unit will invite the hospitals to participate according to:
  • their participation in previous trials coordinated by CLAP,
  • their participation in other trials or research activities, and
  • their location.
  • Of particular interest are the characteristics of each preselected hospital regarding the structure of the professional staff, number of deliveries, and clinical guidelines policy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas

Montevideo, Uruguay

Location

Related Publications (3)

  • Althabe F, Buekens P, Bergel E, Belizan JM, Kropp N, Wright L, Goco N, Moss N; for the Guidelines Trial Group. 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 Apr 11;5(1):4. doi: 10.1186/1472-6874-5-4.

    PMID: 15823211BACKGROUND

  • Kropp N, Hartwell T, Althabe F. Episiotomy rates from eleven developing countries. Int J Gynaecol Obstet. 2005 Nov;91(2):157-9. doi: 10.1016/j.ijgo.2005.07.013. Epub 2005 Oct 5. No abstract available.

    PMID: 16169552BACKGROUND

  • Althabe F, Buekens P, Bergel E, Belizan JM, Campbell MK, Moss N, Hartwell T, Wright LL; Guidelines Trial Group. A behavioral intervention to improve obstetrical care. N Engl J Med. 2008 May 1;358(18):1929-40. doi: 10.1056/NEJMsa071456.

    PMID: 18450604DERIVED

Related Links

Study Officials

  • Pierre Buekens, MD, PhD

    Tulane School of Public Health and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2003

First Posted

October 13, 2003

Study Start

September 1, 2003

Study Completion

December 1, 2006

Last Updated

December 17, 2013

Record last verified: 2013-12

Locations

UR(1)