Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT00070720
Eligibility 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;
* 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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00070720
Study Brief:
Protocol Section:
NCT00070720