Safety of tubal ligation by minilaparotomy provided by clinical officers versus assistant medical officers: study protocol for a noninferiority randomized controlled trial in Tanzanian women

Abstract

Background: Female sterilization by tubal ligation is a safe, extremely effective, and permanent way to limit childbearing. It is the most popular modern contraceptive method worldwide. The simplest way to provide tubal ligation is by a procedure called minilaparotomy, generally performed with the client under local anesthesia with systemic sedation and analgesia. In Tanzania, unmet need for family planning is high and has declined little in the past decade. Access to tubal ligation is limited throughout the country, in large part because of a lack of trained providers. Clinical officers (COs) are midlevel health workers who provide diagnosis, treatment, and minor surgeries. They are more prevalent than physicians in poorer and rural communities. Task shifting-the delegation of some tasks to less-specialized health workers, including task shifting of surgical procedures to midlevel cadres-has improved access to lifesaving interventions in resource-limited settings. It is a cost-effective way to address shortages of physicians, increasing access to services. The primary objective of this trial is to establish whether the safety of tubal ligation by minilaparotomy provided by COs is noninferior to the safety of tubal ligation by minilaparotomy provided by physicians (assistant medical officers [AMOs]), as measured by rates of major adverse events (AEs) during the procedure and through 42 days of follow-up.

Methods/design: In this facility-based, multicenter, noninferiority randomized controlled trial, we are comparing the safety of tubal ligation by minilaparotomy performed by trained COs versus by trained AMOs. The primary outcome is safety, defined by the overall rate of major AEs occurring during the minilaparotomy procedure and through 42 days of follow-up. The trial will be conducted among 1970 women 18 years of age or older presenting for tubal ligation at 7 study sites in northern Tanzania.

Discussion: If no major safety issues are identified, the data from this trial may facilitate changes in the Tanzanian government's regulations, allowing appropriately trained COs to provide tubal ligation by minilaparotomy. Positive findings may have broader implications. Task shifting to provide long-acting contraceptives, if proven safe, may be an effective approach to increasing contraceptive access in low- and middle-income countries.

Trial registration: ClinicalTrials.gov, NCT02944149 . Registered on 14 October 2016.

Keywords: Minilaparotomy; Noninferiority randomized controlled trial; Task shifting; Tubal ligation.

Conflict of interest statement

Ethics approval and consent to participate

The trial protocol (version 1, 25 September 2016) was reviewed and approved by the National Institute for Medical Research, Tanzania, Dar es Salaam, Tanzania (NIMR/HQ/R.8a/Vol.IX/2198, 16 May 2016) and the Western Institutional Review Board, Puyallup, WA, USA (study 1163682, 27 September 2016). The two ethical approvals listed above cover all seven study sites. All participants will undergo informed consent procedures, and no participant will be enrolled until the study staff has obtained legally effective (signed or witnessed) informed consent. All medical procedures in this trial are under the oversight of the Tanzania Ministry of Health, Community Development, Gender, Elderly, and Children.

Consent for publication

Consent for publication is not applicable. All participants will be assigned a trial participant number. Participants will not be identified by name on any documents or in connection with any data that leave the study sites, nor will they be reported by name in any report or publication resulting from data collected in this study.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Trial profile