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

NCT02944149 | Completed DMC

• 1 other identifier: TAN-42
• Study Type: interventional
• Target: 1,970
• Locations: 1 country
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Performance

  During the minilaparotomy procedure

• Participant satisfaction

  During the minilaparotomy procedure and through 42 days follow-up

Study Arms (2)

assistant medical officer (AMO)

ACTIVE COMPARATOR

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

clinical officer (CO)

EXPERIMENTAL

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

Interventions

tubal ligation by minilaparotomy PROCEDURE

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.

Also known as: female sterilization

assistant medical officer (AMO); clinical officer (CO)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• EngenderHealth: lead
• Tanzania Ministry of Health, Community Development, Gender, Elders, and Children: collaborator
• Association of Gynaecologists and Obstetricians of Tanzania: collaborator
• United States Agency for International Development (USAID): collaborator

Study Sites (7)

Daraja Health Centre

Arusha, Arusha, Tanzania

Location

Kaloleni Health Centre

Arusha, Arusha, Tanzania

Location

Levolosi Health Centre

Arusha, Arusha, Tanzania

Location

Karatu Lutheran Hospital

Kiratu, Arusha, Tanzania

Location

Longido Health Centre

Longido, Arusha, Tanzania

Location

Monduli District Hospital

Monduli, Arusha, Tanzania

Location

Mto Wa Mbu Health Center

Monduli, Arusha, Tanzania

Location

Related Publications (2)

• 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.

  PMID: 30120168 DERIVED

• 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.

  PMID: 29073928 DERIVED

MeSH Terms

Interventions

Sterilization, Reproductive

Intervention Hierarchy (Ancestors)

Contraception; Reproductive Techniques; Therapeutics; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Mark A Barone, DVM, MS

  EngenderHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 25, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 3, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

TA (7)