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

NCT ID: NCT02944149

Last Updated: 2017-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1970 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-07-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

tubal ligation by minilaparotomy

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

tubal ligation by minilaparotomy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

female sterilization

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tanzania Ministry of Health, Community Development, Gender, Elders, and Children

UNKNOWN

Sponsor Role: collaborator

Association of Gynaecologists and Obstetricians of Tanzania

UNKNOWN

Sponsor Role: collaborator

United States Agency for International Development (USAID)

FED

Sponsor Role: collaborator

EngenderHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark A Barone, DVM, MS

Role: PRINCIPAL_INVESTIGATOR

EngenderHealth

Locations

Daraja Health Centre

Arusha, Arusha, Tanzania

Kaloleni Health Centre

Arusha, Arusha, Tanzania

Levolosi Health Centre

Arusha, Arusha, Tanzania

Karatu Lutheran Hospital

Kiratu, Arusha, Tanzania

Longido Health Centre

Longido, Arusha, Tanzania

Monduli District Hospital

Monduli, Arusha, Tanzania

Mto Wa Mbu Health Center

Monduli, Arusha, Tanzania

Countries

Tanzania

References

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.

Reference Type: DERIVED

PMID: 30120168 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29073928 (View on PubMed)

Other Identifiers

TAN-42

Identifier Type: -

Identifier Source: org_study_id