Pregnancy Clinical Trial
Official title:
Clustered Trial for Improving Perinatal Care in Uruguay/Argentina
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.
Status | Completed |
Enrollment | 21780 |
Est. completion date | December 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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; - are located within the study area in Argentina and Uruguay; 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 spontaneous vaginal deliveries below 20% - Rate of active management of third stage of labor over 25% The sample size of the study was increased to allow for exclusions. 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Uruguay | Hospital de Clinicas | Montevideo |
Lead Sponsor | Collaborator |
---|---|
NICHD Global Network for Women's and Children's Health | Bill and Melinda Gates Foundation, Global Network for Women's and Children's Health Research, John E. Fogarty International Center (FIC), Latin American Center for Perinatology, National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), Pan American Health Organization, RTI International, Tulane University School of Public Health and Tropical Medicine, University of North Carolina, Chapel Hill, World Health Organization |
Uruguay,
Althabe F, Buekens P, Bergel E, Belizán 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. — View Citation
Kropp N, Hartwell T, Althabe F. Episiotomy rates from eleven developing countries. Int J Gynaecol Obstet. 2005 Nov;91(2):157-9. Epub 2005 Oct 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Episiotomies | |||
Primary | Oxytocin use in third stage of labor | |||
Secondary | Perineal sutures | |||
Secondary | Postpartum hemorrhage | |||
Secondary | Birth attendants' readiness to change status |
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