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

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.

Study Overview

• Status: Completed
• Conditions: Sterilization, Tubal
• Intervention / Treatment: Procedure: tubal ligation by minilaparotomy

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.

• Study Type: Interventional
• Enrollment (Actual): 1970
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Arusha Region
    • Arusha, Arusha Region, Tanzania
      • Daraja Health Centre
    • Arusha, Arusha Region, Tanzania
      • Kaloleni Health Centre
    • Arusha, Arusha Region, Tanzania
      • Levolosi Health Centre
    • Karatu, Arusha Region, Tanzania
      • Karatu Lutheran Hospital
    • Longido, Arusha Region, Tanzania
      • Longido Health Centre
    • Monduli, Arusha Region, Tanzania
      • Monduli District Hospital
    • Monduli, Arusha Region, Tanzania
      • Mto Wa Mbu Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Aged 18 years and older;
• Requested and consented to female sterilization AND additionally freely consents to participate in the study and signs a study informed consent form;
• Is sound of mind, in good general health and deemed suitable to undergo female sterilization by ML in accordance with the Tanzania government guidelines;
• Able to understand study procedures and requirements of study participation;
• Agrees to return to the study site for the full schedule of follow-up visits after her ML procedure;
• Agrees to provide the study staff with an address, phone number, close relative, and/or other locator information while participating in the research study.

Exclusion Criteria:

• Pregnancy
• Between 8 and 42 days postpartum or postabortion
• Known allergy or sensitivity to lidocaine or other local anesthesia
• Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid
• Previous abdominal or pelvic surgery
• Local skin infection near area where incision will be made
• Coagulation disorder
• Hypertension (properly taken measurements; systolic ≥ 160 or diastolic ≥ 100 mm Hg)
• Acute deep venous thrombosis/pulmonary embolism
• Current ischemic heart disease
• Unexplained vaginal bleeding
• Malignant gestational trophoblastic disease
• Cervical, endometrial and/or ovarian cancer
• Pelvic inflammatory disease (current or within the last three months)
• Current purulent cervicitis, chlamydial infection and/or gonorrhea
• Current symptomatic gall bladder disease
• Active viral hepatitis
• Severe anemia (irrespective of type or etiology)
• Tuberculosis of pelvic organs
• Acute bronchitis or pneumonia
• Systematic infection or gastroenteritis
• Currently participating in another biomedical research study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: assistant medical officer (AMO); Assistant medical officers (AMO) are currently allowed to provide tubal ligation by minilaparotomy, however government regulations do not allow clinical officers (COs) to provide this service.	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.; Other Names: female sterilization
Experimental: clinical officer (CO); Experimental: clinical officer (CO) In Tanzania, COs are mid-level providers who offer diagnosis, treatment, and minor surgeries. They are more common in rural areas than medical officers (MOs) and assistant medical officers (AMOs) and are generally considered capable of performing minor surgery. Almost all facilities in Tanzania are understaffed, but COs vastly outnumber MOs and AMOs. COs are more prevalent in poorer and/or rural areas than other higher level cadres; thus, task-shifting to COs would increase access to tubal ligation by minilaparotomy for many women who are most in need.	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.; Other Names: female sterilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety: safety is defined by the overall rate of major adverse events (AEs) during and after the procedure. Rates of major AEs observed during and after procedures conducted by COs vs. AMOs will be compared.	During the minilaparotomy procedure and through 42 days follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance	Performance assessed by (e.g., procedure times, difficulties performing the procedure, inability to complete the procedure, need for assistance to complete the procedure, maximum reported pain experienced by the participant during the procedure) between procedures performed by COs and AMOs will be compared	During the minilaparotomy procedure
Participant satisfaction	Participant satisfaction with the minilaparotomy experience conducted by COs and AMOs will be compared.	During the minilaparotomy procedure and through 42 days follow-up

Collaborators and Investigators

• Sponsor: EngenderHealth
• Collaborators: United States Agency for International Development (USAID); Tanzania Ministry of Health, Community Development, Gender, Elders, and Children; Association of Gynaecologists and Obstetricians of Tanzania
• Investigators: Principal Investigator: Mark A Barone, DVM, MS, EngenderHealth

Publications and helpful links

General Publications

• Barone MA, Mbuguni Z, Achola JO, Almeida A, Cordero C, Kanama J, Marquina A, Muganyizi P, Mwanga J, Ouma D, Shannon C, Tibyehabwa L. Safety of Tubal Occlusion by Minilaparotomy Provided by Trained Clinical Officers Versus Assistant Medical Officers in Tanzania: A Randomized, Controlled, Noninferiority Trial. Glob Health Sci Pract. 2018 Oct 4;6(3):484-499. doi: 10.9745/GHSP-D-18-00108. Print 2018 Oct 3.
• Barone MA, Mbuguni Z, Achola JO, Cordero C, Kanama J, Muganyizi PS, Mwanga J, Shannon C, Tibyehabwa L. 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. Trials. 2017 Oct 26;18(1):499. doi: 10.1186/s13063-017-2235-6.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: October 14, 2016
• First Submitted That Met QC Criteria: October 23, 2016
• First Posted (Estimate): October 25, 2016

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: TAN-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No