Clinical trial NCT02944149: Safety of Minilaparotomy Provided by Trained Clinical Officers and Assistant Medical Officers: a Non-inferiority Trial
Official title: Safety of Minilaparotomy Provided by Trained Clinical Officers and Assistant Medical Officers: a Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sterilization, Tubal
Lead sponsor: EngenderHealth
Sponsor class: OTHER
Collaborators: name: Tanzania Ministry of Health, Community Development, Gender, Elders, and Children
name: Association of Gynaecologists and Obstetricians of Tanzania
name: United States Agency for International Development (USAID)
First posted: 2016-10-25
Enrollment: 1970
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: 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.
timeFrame: During the minilaparotomy procedure and through 42 days follow-up
Secondary outcomes:
measure: Performance
timeFrame: During the minilaparotomy procedure
measure: Participant satisfaction
timeFrame: During the minilaparotomy procedure and through 42 days follow-up
Other outcomes:
Locations:
city: Arusha
country: Tanzania
facility: Daraja Health Centre
state: Arusha Region
city: Arusha
country: Tanzania
facility: Kaloleni Health Centre
state: Arusha Region
city: Arusha
country: Tanzania
facility: Levolosi Health Centre
state: Arusha Region
city: Karatu
country: Tanzania
facility: Karatu Lutheran Hospital
state: Arusha Region
city: Longido
country: Tanzania
facility: Longido Health Centre
state: Arusha Region
city: Monduli
country: Tanzania
facility: Monduli District Hospital
state: Arusha Region
city: Monduli
country: Tanzania
facility: Mto Wa Mbu Health Center
state: Arusha Region
Study officials:
affiliation: EngenderHealth
name: Mark A Barone, DVM, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.