NCT02944149

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,970 (actual)
• Sponsor: EngenderHealth · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary objective is to establish whether the safety of ML provided by trained COs is not inferior to the safety of ML provided by trained AMOs, as measured by rates of major adverse events (AEs) among women undergoing ML. The primary outcome is safety, defined by the overall rate of major AEs following ML. The investigators will address the primary objective by comparing the rate of major AEs observed following MLs conducted by COs vs. AMOs during the ML procedure and through 42 days follow-up. This study will be conducted among 1,970 women 18 years of age and older presenting at study sites for ML surgery. The duration of a woman's participation in the study is expected to be 6 weeks, unless additional follow-up beyond 42 days is clinically indicated due to complications or for other reasons. The study will be conducted in Arusha Region in northern Tanzania. The following health facilities will serve as study sites: Daraja Health Centre, Karatu Hospital, Kaloleni Health Centre, Levolosi Urban Health Centre, Longido Health Centre, Monduli Hospital, and Mto wa Mbu Health Centre.

Conditions

• Sterilization, Tubal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2016-10-25
• Last updated: 2017-08-03

Locations

7 sites across 1 country: Tanzania