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

Autor: Leopold Tibyehabwa, Projestine Muganyizi, Caitlin Shannon, Jamilla Mwanga, Mark A. Barone, Zuhura Mbuguni, Japhet Ominde Achola, Joseph Kanama, Carmela Cordero
Rok vydání: 2017
Předmět:
medicine.medical_specialty
Time Factors
Sterilization
Tubal
Sedation
Psychological intervention
Alternative medicine
Allied Health Personnel
Medicine (miscellaneous)
Tanzania
Health Services Accessibility
law.invention
03 medical and health sciences
Study Protocol
0302 clinical medicine
Postoperative Complications
Randomized controlled trial
Clinical Protocols
law
Risk Factors
Medicine
Humans
Pharmacology (medical)
Local anesthesia
030212 general & internal medicine
Tubal ligation
lcsh:R5-920
Laparotomy
030219 obstetrics & reproductive medicine
biology
business.industry
Minilaparotomy
Task shifting
Noninferiority randomized controlled trial
medicine.disease
biology.organism_classification
Surgery
Treatment Outcome
Family planning
Research Design
Family Planning Services
Female
Medical emergency
Clinical Competence
Rural Health Services
medicine.symptom
business
lcsh:Medicine (General)
Zdroj: Trials
Trials, Vol 18, Iss 1, Pp 1-11 (2017)
ISSN: 1745-6215
Popis: Background Female sterilization by tubal ligation is a safe, extremely effective, and permanent way to limit childbearing. It is the most popular modern contraceptive method worldwide. The simplest way to provide tubal ligation is by a procedure called minilaparotomy, generally performed with the client under local anesthesia with systemic sedation and analgesia. In Tanzania, unmet need for family planning is high and has declined little in the past decade. Access to tubal ligation is limited throughout the country, in large part because of a lack of trained providers. Clinical officers (COs) are midlevel health workers who provide diagnosis, treatment, and minor surgeries. They are more prevalent than physicians in poorer and rural communities. Task shifting—the delegation of some tasks to less-specialized health workers, including task shifting of surgical procedures to midlevel cadres—has improved access to lifesaving interventions in resource-limited settings. It is a cost-effective way to address shortages of physicians, increasing access to services. The primary objective of this trial is to establish whether the safety of tubal ligation by minilaparotomy provided by COs is noninferior to the safety of tubal ligation by minilaparotomy provided by physicians (assistant medical officers [AMOs]), as measured by rates of major adverse events (AEs) during the procedure and through 42 days of follow-up. Methods/design In this facility-based, multicenter, noninferiority randomized controlled trial, we are comparing the safety of tubal ligation by minilaparotomy performed by trained COs versus by trained AMOs. The primary outcome is safety, defined by the overall rate of major AEs occurring during the minilaparotomy procedure and through 42 days of follow-up. The trial will be conducted among 1970 women 18 years of age or older presenting for tubal ligation at 7 study sites in northern Tanzania. Discussion If no major safety issues are identified, the data from this trial may facilitate changes in the Tanzanian government’s regulations, allowing appropriately trained COs to provide tubal ligation by minilaparotomy. Positive findings may have broader implications. Task shifting to provide long-acting contraceptives, if proven safe, may be an effective approach to increasing contraceptive access in low- and middle-income countries. Trial registration ClinicalTrials.gov, NCT02944149. Registered on 14 October 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2235-6) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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