Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tanzania Ministry of Health, Community Development, Gender, Elders, and Children | UNKNOWN |
| Association of Gynaecologists and Obstetricians of Tanzania | UNKNOWN |
| United States Agency for International Development (USAID) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark A Barone, DVM, MS | EngenderHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daraja Health Centre | Arusha | Arusha | Tanzania | |||
| Kaloleni Health Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30120168 | Derived | 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. | |
| 29073928 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| 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 |
| 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. |
| ID | Term |
|---|---|
| D013245 | Sterilization, Reproductive |
| ID | Term |
|---|---|
| D003267 | Contraception |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided