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

Sterilization, Tubal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02944149
• Other study ID #: TAN-42
• Status: Completed
• Phase: N/A
• First received: October 14, 2016
• Last updated: August 1, 2017
• Start date: December 2016
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: EngenderHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1970
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sterilization, Tubal

Intervention

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.

Locations

Country	Name	City	State
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

Sponsors (4)

Lead Sponsor	Collaborator
EngenderHealth	Association of Gynaecologists and Obstetricians of Tanzania, Tanzania Ministry of Health, Community Development, Gender, Elders, and Children, United States Agency for International Development/Tanzania

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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