Safety of Minilaparotomy Provided by Trained Clinical Officers and Assistant Medical Officers: a Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,970
- 试验地点
- 7
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: tubal ligation by minilaparotomy (Procedure)
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.
干预措施: tubal ligation by minilaparotomy (Procedure)
结局指标
主要结局
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.
时间窗: During the minilaparotomy procedure and through 42 days follow-up
次要结局
- Performance(During the minilaparotomy procedure)
- Participant satisfaction(During the minilaparotomy procedure and through 42 days follow-up)