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Home > "I" Clinical Trials Conditions > Improving Perinatal Care in Latin America  Improving Perinatal Care in Latin America
Improving Perinatal Care in Latin America
For Condition: Episiotomy,Practice Guidelines,Labor Stage, Third,Physician's Practice Patterns
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , Latin American Center for Perinatology,Pan American Health Organization,World Health Organization,Tulane University School of Medicine,University of North Carolina,RTI International,Global Network for Women’s and Children’s Health Research,Bill and Melinda Gates Foundation
Synopsis: The aim of this project is to perform a cluster randomized, controlled trial of a behavioral intervention in Argentina and Uruguay that will increase the use of two evidence-based birth practices, the selective use of episiotomies and active management of the third stage of labor. The intervention will be based on the stages of change and organizational change theories and tailored by formative research that will include baseline questionnaires and focus groups.
Details: Twenty-four hospitals in three urban districts of Argentina and Uruguay will be randomly assigned to an intervention or control group. Opinion leaders in the 12 intervention hospitals will be identified and trained to develop evidence-based guidelines that will be diffused by a multifaceted approach including seminars, academic detailing, reminders, and feedback on utilization rates. The 12 hospitals in the nonintervention group will continue with their standard in-service training activities. The main outcomes to be assessed are the use of episiotomies and of oxytocin during the third stage of labor. Secondary outcomes will be perineal sutures, potspartum hemorrhages, and birth attendants’ readiness to change status.
Eligibility:
Study Type: Interventional,Educational/Counseling/Training,Randomized,Open Label,Active Control,Parallel Assignment,Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion Criteria for Hospitals 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; and •agree to participate in the study. Exclusion Criteria for Hospitals 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 primiparous women with spontaneous vaginal deliveries below 70% •Rate of active management of third stage of labor over 25% Because these hospitals do not have a policy for selective episiotomy or active management, it is expected that none of them will be excluded by this criteria. The sample size of the study was increased to allow for exclusions. Interviews with the Head of the Obstetrical Department from 23 potentially eligible hospitals during the month of June 2000 revealed that 21 were performing episiotomies routinely among primiparae and that expectant management during the third stage of labor was the standard form of care. 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 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.
Total Enrollment: 24
Location and Contact Information:
Latin American Center for Perinatology *Recruiting*
Montevideo, ,
Uruguay
Recruiting Fernando Althabe (598-2) 604 4911
Additional Information:
Study ID Numbers: GN 01;
Study Start Date: September 2003
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070720
Other Episiotomy Studies:
1. Improving Perinatal Care in Latin America
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Other Episiotomy Clinical Trials
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Other Montevideo Clinical Trials
Improving Perinatal Care in Latin America
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