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Safety of Minilaparotomy Provided by Trained Clinical Officers and Assistant Medical Officers: a Non-inferiority Trial

NCT02944149 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1970

Last updated 2017-08-03

No results posted yet for this study

Summary

The study is a non-inferiority randomized controlled trial (RCT) that aims to demonstrate that tubal ligations by minilaparotomy (ML) conducted by trained clinical officers (COs) are no less safe as compared to those conducted by assistant medical officers (AMOs) in Tanzania. Participants will be randomized in a one to one ratio to ML by a CO and ML by an AMO. In addition to the screening and enrollment/ML visit, there will be three scheduled follow-up visits at 3, 7 and 42 days post-surgery.

Conditions

  • Sterilization, Tubal

Interventions

PROCEDURE

tubal ligation by minilaparotomy

Tubal ligation will be performed by minilaparotomy as per the Tanzanian government standards, with the standard family planning counseling and minilaparotomy surgical protocols used by the government being followed during the study.

Sponsors & Collaborators

  • Tanzania Ministry of Health, Community Development, Gender, Elders, and Children

    collaborator UNKNOWN

  • Association of Gynaecologists and Obstetricians of Tanzania

    collaborator UNKNOWN

  • United States Agency for International Development (USAID)

    collaborator FED

  • EngenderHealth

    lead OTHER

Principal Investigators

  • Mark A Barone, DVM, MS · EngenderHealth

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02944149 on ClinicalTrials.gov