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PROTOCOL. Task sharing to improve post abortion care. RCT District level Uganda.
Protocol version I. Date: 130405
Trial title: Task sharing to improve post abortion care and contraceptive counselling at district level- randomised controlled trial in Uganda.
Clinical Trial registration; ClinicalTrials.org NCT 01844024.
Principal investigator
Kristina Gemzell-Danielsson, MD PhD
Department of Woman and Child Health,
Division of Obstetrics and Gynaecology,
Karolinska Institutet,
Karolinska University Hospital,
SE-17176 Stockholm, Sweden telephone: + 46 8517 72128 telefax no.: +46 8517-74314 email : kristina.gemzell@ki.se
Protocol Date: 130405
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PROTOCOL. Task sharing to improve post abortion care. RCT District level Uganda.
Protocol version I. Date: 130405
Brief summary
Uganda is one of the countries with highest fertility rate in the world, 6.7 children per women.
It is estimated that 56 percent of all pregnancies are unintended and the contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and induced abortion is illegal. Unsafe abortion is responsible for significant morbidity and mortality among women in Uganda. Almost 40% of admissions to emergency obstetric care units in
Uganda due to unsafe abortion is reported and considered high in international comparison.
Studies have revealed that trained midlevel providers can deliver safe post abortion care
(PAC) for incomplete abortion and use manual vacuum aspiration. The prostaglandin E1 analogue misoprostol has been shown to be an effective tool in the treatment of incomplete abortions. This option is so far under-used in developing countries, especially outside the larger hospitals and private clinics. One significant limiting factor in providing safe PAC is the lack of providers. So far technical training has been mainly limited to physicians. The long-term goal of this project is to provide evidence based information that will contribute to the development of strategies to increase women’s access to high level post- abortion care at primary health care level provided by midlevel providers in Uganda. A task shift to midlevel provider in providing treatment of incomplete abortion will increase access to safe PAC and is a key to MDG5. Misoprostol treatment of incomplete abortion remains underused and in accessible to a majority of women in Uganda because national regulations restricts its prescription and supervision to doctors. However, the safety of misoprostol treatment should make it amenable to provision by midlevel providers. Training of midlevel providers in misoprostol treatment of incomplete abortion will support task shifting in places where doctors are costly and scarce. By evaluating the effectiveness of mid-level providers
(midwives); administering misoprostol treatment of incomplete abortion the project is attempting to contribute to the reduction of maternal mortality and morbidity and safeguard high quality of post-abortion care. A direct economic impact can also be expected due to reduced treatment costs of complications from unsafely induced abortion and incomplete abortions. The involvement of midlevel providers in medical treatment of incomplete abortion has previously not been systematically evaluated in African primary health care setting. Our hypothesis is that there is no difference in safety and effectiveness when misoprostol treatment of incomplete abortion is provided by midlevel providers compared with physicians.
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PROTOCOL. Task sharing to improve post abortion care. RCT District level Uganda.
Protocol version I. Date: 130405
General aim: To study the safety, efficacy and effectiveness of misoprostol treatment of incomplete abortion, provided to women by physicians or midlevel providers at primary health care level in Uganda, and to study women’s acceptance and experiences of the method.
Objectives:
(1) To assess the effectiveness and safety of midlevel providers in administering misoprostol for treatment of incomplete abortion as compared to physicians
(2) To analyse women’s acceptance and experiences of misoprostol for treatment of incomplete abortion
Definitions
Incomplete abortion: Includes spontaneous and induced abortion.
Misoprostol treatment: A prostaglandin E1 analogue, effective in the treatment of incomplete abortion. Based on its proven safety and efficacy for the treatment of incomplete abortion misoprostol has been added to the WHO Model List of Essential Medicines (WHO, 2009).
Midlevel providers : Registered Midwives.
Task shifting , is defined as a process of delegating tasks, where/when appropriate, to less specialized health care providers and has been identified to increase the productivity within health care systems (Fulton et al, 2011).
Project description
The project is to be implemented at 6 Regional/District hospitals and Health Centres IV, which is the lowest health care level staffed with both physicians and midwives. Facilities identified are situated in the following districts; Mpigi, Luweero, Entebbe, Nakasaeke,
Gombe, Masak and are all located around Kampala within 1-2 hour drive. A Regional/District
Hospital and Health Centre IV is a public health facility equipped to provide basic and emergency obstetric service in rural and peri-urban areas. The facilities identified for inclusion in study I have sufficient staff to establish a group of midwives (29) and physicians
(19) and sufficient caseload (56 cases of incomplete abortions/week). A coordinating centre will be established at the Mulago Hospital in Kampala in order to monitor the study. Included in the coordinating team are physicians who will have the ultimate responsibility for the medical care provided. All health care providers (midwives and physicians) providing PAC will be trained according to standardized PAC training modules that are used internationally.
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PROTOCOL. Task sharing to improve post abortion care. RCT District level Uganda.
Protocol version I. Date: 130405
Detailed description
Eligibility : Women presenting with symptoms of incomplete first trimester abortion (induced or spontaneous) at the six facilities included in the project, are eligible.
Inclusion criteria: Bleeding and contractions during pregnancy opening cervix and no expulsion.
Exclusions criteria: Complete abortion, known allergy to misoprostol, a uterine size of more than 12 weeks of gestation, suspected ectopic pregnancy, unstable hemodynamic status and shock, signs of pelvic infection and/or sepsis.
Sample size estimate: The sample size has been calculated with the objective of showing two-sided equivalence, assuming that the overall complication rate could be as high as 4 percent and would apply to both types of providers. With a power of 80%, a set difference d of 2.2% as a clinically important difference, 5% level of significance of results. With the success rate of 96% for physicians and midwives the sample size becomes 452 per arm.
Compensating for 10% loss to follow up would give a total number of 994. This trial is planned to be performed and reported in accordance with CONSORT guidelines (Schulz KF et al 2010) and will be registered at ClinicalTrials.gov.
Enrollment and informed consent process: Step One: The research assistants explain the study to the client verbally, providing all pertinent information (purpose, procedures, risks, benefits, alternatives to participation, etc.), and allow the client opportunity to ask questions.
Step Two: Following the verbal explanation, the client will be provided with a study information sheet and given sufficient time to consider whether or not to participate in the research. Step Three: After allowing the client time to read the study information letter, the research assistants answer any questions the client may have in order to obtain verbal and written agreement to participate in the study.
Random allocation: The randomization will be conducted in blocks of 6. A computer random number generator will be used to generate a list of codes from 1 to 994 and each code is linked to one of the two groups – A and B. The list will be used while sequentially
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PROTOCOL. Task sharing to improve post abortion care. RCT District level Uganda.
Protocol version I. Date: 130405 numbered, opaque, sealed envelopes will be prepared by the research team. Each envelope contains a study protocol for the individual woman. Process evaluation will be conducted by intermittent check-ups in order to assure that the intervention procedures are performed correctly and that they follow the protocol. The check-ups will be made by a researcher and include both a review of the completed protocols and repetition and education of the physicians and midlevel providers involved in the study.
Clinical assessment: All eligible women who consent to participation will undergo a clinical assessment by the provider they have been randomized to.
The clinical assessment includes:
(i) History taking (socio-demographic information, Last Menstrual Period (LMP),
Medical including Obstetric and Gynaecological history, contraceptive history, signs and symptoms)
(ii) General physical examination (pulse, blood pressure and temperature);
(iii) Pelvic examination that includes examination of any signs of genital infections, size of the uterus (external genitalia, speculum examination, bimanual examination,
Before discharge all women will be given detailed information regarding bleeding and pain expected and abnormal symptoms (fever, and foul smelling vaginal discharge) following treatment and the importance of seeking care if such symptoms occur.
Main and secondary outcomes
Main and secondary outcomes will be measured at follow a up visit, 14 days + 2 weeks after the initial visit. The main outcome is complete abortion, requiring no further medical or surgical intervention. The clinical assessments of the main outcome are : (i) Physical examination (pulse, blood pressure and temperature); (ii) Pelvic examination that includes examination of size of the uterus (external genitalia, speculum examination, bimanual examination).
Secondary outcomes are; (i) bleeding, (ii) pain, (iii) women’s experiences of the method and care provided, (iv) un-scheduled visits will be recorded. Measurements of secondary outcomes are: (i) symptom diary card used by women to assess daily bleeding and pain. The intensity of bleeding will be self-reported by the women in relation to normal menstrual bleeding (categorised 1=much less than up to 5= much heavier than: (ii) Haemoglobin level
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PROTOCOL. Task sharing to improve post abortion care. RCT District level Uganda.
Protocol version I. Date: 130405 pre- and post- treatment: (iii) Pain reported using visual analogue scale (VAS). before any use of analgesia. Standardized questionnaires will be used to collect information about women’s acceptability and experiences of the treatment and time spent on travelling and on clinical visits following treatment.
Data management
The study coordinator will be monitoring the data collection and verify protocol completion.
A statistician will do the data entry including coding and cleaning and will also be involved in planning, reviewing of the protocol and in analysis of the results. Data monitoring will be provided by staff at the Mulago hospital/Makerere University. A group of independent experts with different competence will form a Data safety monitoring board in order to monitor patient safety and treatment efficacy data while the randomized control trial is ongoing.
Statistical analyses: All analyses will be by Intention to Treat (ITT). Background characteristics for the two study groups and categorical outcomes will be presented using descriptive statistics. Intergroup comparison will be made between women treated by physician/midwife. Differences between groups will be analysed using relative risks (95%
CI). P-values equal to or lower than 0.05 will be considered statistically significant.
Ethical approval: Rec ref: 2012-129. Research Ethics Committee, Makerere University,
College of Health Sciences/ School of Medicine and Uganda National Council for Science and Technology Dnr: HS 1314 and the Swedish regional ethics review board at Karolinska
Institutet Dnr: 2013/2;9.
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