Safety of Tubal Occlusion by Minilaparotomy Provided by Trained Clinical Officers Versus Assistant Medical Officers in Tanzania: A Randomized, Controlled, Noninferiority Trial

Abstract

Background: Tubal occlusion by minilaparotomy is a safe, highly effective, and permanent way to limit childbearing. We aimed to establish whether the safety of the procedure provided by trained clinical officers (COs) was not inferior to the safety when provided by trained assistant medical officers (AMOs), as measured by major adverse event (AE) rates.

Methods: In this randomized, controlled, open-label noninferiority trial, we enrolled participants at 7 health facilities in Arusha region, Tanzania, as well as during outreach activities conducted in Arusha and neighboring regions. Consenting, eligible participants were randomly allocated by a research assistant at each site to minilaparotomy performed by a trained CO or by a trained AMO, in a 1:1 ratio. We asked participants to return at 3, 7, and 42 days postsurgery. The primary outcome was the rate of major AEs following minilaparotomy performed by COs versus AMOs, during the procedure and through 42 days follow-up. The noninferiority margin was 2%. The trial is registered with ClinicalTrials.gov, Identifier NCT02944149.

Results: We randomly allocated 1,970 participants between December 2016 and June 2017, 984 to the CO group and 986 to the AMO group. Most (87%) minilaparotomies were conducted during outreach services. In the intent-to-treat analysis, 0 of 978 participants had a major AE in the CO group compared with 1 (0.1%) of 984 in the AMO group (risk difference: -0.1% [95% confidence interval: -0.3% to 0.1%]), meeting the criteria for noninferiority. We saw no evidence of differences in measures of procedure performance, participant satisfaction, or provider self-efficacy between the groups.

Conclusions: Tubal occlusion by minilaparotomy performed by trained COs is safe, effective, and acceptable to women, and the procedure can be safely and effectively provided in outreach settings. Our results provide evidence to support policy change in resource-limited settings to allow task shifting of minilaparotomy to properly trained and supported COs, increasing access to female sterilization and helping to meet the rising demand for the procedure among women wanting to avoid pregnancy. They also suggest high demand for these services in Tanzania, given the large number of women recruited in a relatively short time period.

© Barone et al.

Figures

Health facility staff discuss family planning options with women waiting for outreach services in northern Tanzania. © 2016 EngenderHealth

A clinical officer screens a woman for tubal ligation in a health facility in northern Tanzania. © 2014 EngenderHealth/S. Lewis

FIGURE 1

Trial Profile Abbreviations: AMO, assistant medical officers; CO, clinical officers. a Randomization was done via a text message service. In these 2 cases, a cellular network outage prevented the study site from randomizing the participants. b Just before the start of the procedure, 3 participants became nervous and withdrew consent. c These participants were deemed to have met the study eligibility criteria and were randomized. However, before the procedure commenced, it was decided that they did not meet the criteria for the following reasons: anemia, high blood pressure, pelvic inflammatory disease, or unexplained vaginal bleeding. d In this case, the participant was randomized, but a cellular network outage prevented the study site from determining the assigned random allocation group before the minilaparotomy procedure needed to be conducted for logistical reasons. The participant was discontinued. e The procedure was not completed because the participant was unsettled, as the procedure was taking a long time. She asked that they stop the procedure. f Adhesions made delivering the right tube a problem, and the procedure could not be completed, even with the supervisor's assistance.

FIGURE 2

Interpretation of Risk Difference Between AMOs and COs for the Percentage of Women Experiencing a Major Adverse Event Abbreviations: AMO, assistant medical officer; CI, confidence interval; CO, clinical officer. The green diamond represents the point estimate of the risk difference (–0.1%) and the horizontal line to the left and right of the diamond represents the associated 2-sided 95% CI (–0.3%, 0.1%). Noninferiority of minilaparotomy performed by a CO is accepted because the upper limit of the 95% CI falls below the predefined noninferiority margin of 2%.

A woman undergoes tubal ligation by minilaparotomy in a health facility in northern Tanzania. © 2015 EngenderHealth/S. Lewis