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出境医 / 临床实验 / Safety of Minilaparotomy Provided by Trained Clinical Officers and Assistant Medical Officers: a Non-inferiority Trial

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Sterilization, Tubal Procedure: tubal ligation by minilaparotomy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1970 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Safety of Minilaparotomy Provided by Trained Clinical Officers and Assistant Medical Officers: a Non-inferiority Trial
Actual Study Start Date : December 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017
Arms and Interventions
Arm Intervention/treatment
Active Comparator: 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.
 Procedure: 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.
Other Name: female sterilization
Experimental: 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.
 Procedure: 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.
Other Name: female sterilization
Outcome Measures
Primary Outcome Measures :
  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. [ Time Frame: During the minilaparotomy procedure and through 42 days follow-up ]

Secondary Outcome Measures :
  1. Performance [ Time Frame: During the minilaparotomy procedure ]
    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

  2. Participant satisfaction [ Time Frame: During the minilaparotomy procedure and through 42 days follow-up ]
    Participant satisfaction with the minilaparotomy experience conducted by COs and AMOs will be compared.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Locations
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Tanzania
Daraja Health Centre
Arusha, Arusha Region, Tanzania
Kaloleni Health Centre
Arusha, Arusha Region, Tanzania
Levolosi Health Centre
Arusha, Arusha Region, Tanzania
Karatu Lutheran Hospital
Karatu, Arusha Region, Tanzania
Longido Health Centre
Longido, Arusha Region, Tanzania
Monduli District Hospital
Monduli, Arusha Region, Tanzania
Mto Wa Mbu Health Center
Monduli, Arusha Region, Tanzania
Sponsors and Collaborators
EngenderHealth
Tanzania Ministry of Health, Community Development, Gender, Elders, and Children
Association of Gynaecologists and Obstetricians of Tanzania
United States Agency for International Development (USAID)
Investigators
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Principal Investigator: Mark A Barone, DVM, MS EngenderHealth
Tracking Information
First Submitted Date  ICMJE October 14, 2016
First Posted Date  ICMJE October 25, 2016
Last Update Posted Date August 3, 2017
Actual Study Start Date  ICMJE December 2016
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2016) 		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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2016)
  • Performance [ Time Frame: During the minilaparotomy procedure ]
    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
  • Participant satisfaction [ Time Frame: During the minilaparotomy procedure and through 42 days follow-up ]
    Participant satisfaction with the minilaparotomy experience conducted by COs and AMOs will be compared.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Minilaparotomy Provided by Trained Clinical Officers and Assistant Medical Officers: a Non-inferiority Trial
Official Title  ICMJE Safety of Minilaparotomy Provided by Trained Clinical Officers and Assistant Medical Officers: a Non-inferiority Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Sterilization, Tubal
Intervention  ICMJE Procedure: 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.
Other Name: female sterilization
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Procedure: tubal ligation by minilaparotomy
  • Experimental: 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.
    Intervention: Procedure: tubal ligation by minilaparotomy
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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2016) 		1970
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tanzania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02944149
Other Study ID Numbers  ICMJE TAN-42
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party EngenderHealth
Study Sponsor  ICMJE EngenderHealth
Collaborators  ICMJE
  • Tanzania Ministry of Health, Community Development, Gender, Elders, and Children
  • Association of Gynaecologists and Obstetricians of Tanzania
  • United States Agency for International Development (USAID)
Investigators  ICMJE
Principal Investigator: Mark A Barone, DVM, MS EngenderHealth
PRS Account EngenderHealth
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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