Post-abortion Care and Contraceptive Counselling by Midwives or Physicians
Condition: Pregnancy
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this project is to study the safety, efficacy and effectiveness of medical
      treatment of incomplete abortion provided to women by physicians or midwives in Kisumu,
      Kenya.

      In Kenya, Post Abortion Care (PAC), provided by physicians, nurse-midwives and clinical
      officers, has been integrated at private reproductive health facilities since 1998.
      Misoprostol as treatment of incomplete abortion was launched I Nyanza Province in April,
      2012. The involvement of midwives in medical (Misoprostol) treatment of incomplete abortion
      has, however, not been systematically evaluated. There is a need to determine whether
      midwives and physician can perform medical treatment of incomplete abortion equally safe and
      effective in Kenya. The results will thus provide evidence-based information that can
      contribute to the development of strategies to increase women's access to Post Abortion Care
      in Kenya as well as in other low-income contexts.
    

Detailed description: 
      The project will take place at Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH)
      and Kisumu East District Hospital (KEDH), in Kisumu County of Nyanza Province in Western
      Kenya. The project will be implemented within the Department of Obstetrics and Gynaecology at
      the two facilities. Altogether the two facilities admit around 60 women per month with
      incomplete abortion. Midwives and physicians included in the project will undergo a
      standardized training prior to the study. This will include basic knowledge on treatment of
      incomplete abortion and post abortion contraceptive counselling as well as interview
      technique. The training will be both theoretical and practical and on-going during the
      project in order to cover all / new staff.

      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 4-5 percent and would apply
      to both types of providers. To demonstrate two-sided equivalence within a margin of 4-5
      percent with 80% power and using a 95% CI (α=0.05), about 816 women would need to be
      recruited. In addition, about 10 percent could be expected lost to follow up and will be
      adjusted for. Thus, a total of 880 women will be recruited. The randomization will be
      conducted in blocks of 8 and will vary randomly. A computer random number generator will be
      used to generate a list of codes from 1 to 880 and each code is linked to one of the two
      groups - A= PAC care and misoprostol by midwife and B= PAC care and misoprostol by physician.
      The list will be used while sequentially numbered, opaque, sealed envelopes will be prepared
      by the research team. Each envelope contains a study protocol for the individual woman. At
      the time of allocation, the research assistant at the clinic will pick the envelope with the
      lowest number, write the participant's name and personal registration number on it, and then
      open it. 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 midwives involved in the study.

      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) medical history
      taking , Last Menstrual Period (LMP), Obstetric and Gynaecological history, contraceptive
      history, symptoms) (ii) General physical examination (pulse, blood pressure and temperature);
      (iii) Pelvic examination that include examination of size of the uterus (External genitalia,
      speculum examination, Bimanual examination). Before discharge all women will be given
      detailed information regarding bleeding and pain expected following treatment as well as
      abnormal symptoms (fever, and foul smelling vaginal discharge) and the importance of seeking
      care if such symptoms occur. All women will be followed-up after 7 - 10 days.

      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.
      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.
    

Intervention name(s): Medical Post Abortion Care
Intervention type(s): Other
Intervention description(s): Women with incomplete abortion is diagnosed and treated with misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research