Sterilization, TubalNCT02944149
Safety of Minilaparotomy Provided by Trained Clinical Officers and Assistant Medical Officers: a Non-inferiority Trial
A study testing tubal ligation by minilaparotomy in people with Sterilization, Tubal, run by EngenderHealth at 7 sites in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sterilization, Tubal
- What is being tested?
- tubal ligation by minilaparotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,970 participants
- Where
- 7 sitesTanzania
- Study dates
- Dec 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Tanzania7 sites
Daraja Health Centre
Arusha, Arusha
Kaloleni Health Centre
Arusha, Arusha
Levolosi Health Centre
Arusha, Arusha
Karatu Lutheran Hospital
Kiratu, Arusha
Longido Health Centre
Longido, Arusha
Monduli District Hospital
Monduli, Arusha
Mto Wa Mbu Health Center
Monduli, Arusha
About this study
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.
Read the 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
- Being tested
- tubal ligation by minilaparotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tubal ligation by minilaparotomyProcedure or surgery
Also called female sterilization
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: tubal ligation by minilaparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the minilaparotomy procedure and through 42 days follow-up
Secondary outcomes (2)
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
Measured: During the minilaparotomy procedure
Participant satisfaction
Participant satisfaction with the minilaparotomy experience conducted by COs and AMOs will be compared.
Measured: During the minilaparotomy procedure and through 42 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sterilization, TubalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,970 participants (actual)
Sponsor and investigators
- Lead sponsor
- EngenderHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Tanzania Ministry of Health, Community Development, Gender, Elders, and Children, Association of Gynaecologists and Obstetricians of Tanzania, United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Mark A Barone, DVM, MS, Principal investigator, EngenderHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944149
- Sponsor's protocol ID
- TAN-42
- Status last verified
- Aug 2017
- First submitted
- 14 Oct 2016
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 30120168Barone 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.
PubMed 29073928
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Minilaparotomy Provided by Trained Clinical Officers and Assistant Medical Officers: a Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT02944149
- Acronym / sponsor ID
- TAN-42
- Conditions
- Sterilization, Tubal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,970 participants (actual)
- Lead sponsor
- EngenderHealthUniversity, hospital or other
- Collaborators
- Tanzania Ministry of Health, Community Development, Gender, Elders, and Children, Association of Gynaecologists and Obstetricians of Tanzania, United States Agency for International Development (USAID)
- Study start
- Dec 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 25 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| assistant medical officer (AMO) | Active comparator | Procedure: tubal ligation by minilaparotomyAssistant 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 | Procedure: tubal ligation by minilaparotomyExperimental: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tubal ligation by minilaparotomyAlso: female sterilizationTubal 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. | Procedure or surgery | assistant medical officer (AMO), clinical officer (CO) |
Primary outcome
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.
Time frame: During the minilaparotomy procedure and through 42 days follow-up
2 secondary outcomes
Performance
Time frame: During the minilaparotomy procedure
Participant satisfaction
Time frame: During the minilaparotomy procedure and through 42 days follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Derived from this study: PubMed 30120168Barone 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.
- Derived from this study: PubMed 29073928Barone 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.
- Individual participant dataSharing planned: No
Related trials for Sterilization, Tubal
Recruiting
Patient-centered Information on Permanent Contraception
Contraception, Reproductive Behavior
Recruiting
Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
Fallopian Tube Patency Tests, Fibroid/Myoma (Uterus/Cervix)
Active, not recruiting
SALpingectomy for STERilization (SALSTER)
Sterilization Tubal, Salpingectomy
Enrolling by invitationObservational study
Stop Ovarian Cancer Young; Effect of the Opportunistic Salpingectomy on Age of Menopause
Salpingectomy, Tubal Ligation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Barone, DVM, MS principal investigator
EngenderHealth
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tubal ligation by minilaparotomy in people with Sterilization, Tubal, run by EngenderHealth at 7 sites in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: During the minilaparotomy procedure and through 42 days follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02944149, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.