Post-abortion Care and Contraceptive Counselling by Midwives or Physicians

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Karolinska Institutet
Sponsor:
Collaborators:
Kenya Medical Research Institute
University of Nairobi
Information provided by (Responsible Party):
Marie Klingberg-Allvin, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01865136
First received: May 26, 2013
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Pregnancy
Other: Medical Post Abortion Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Post-abortion Care and Contraceptive Counselling by Midwives or Physicians - a Randomized Controlled Trial in Kisumu, Western Kenya

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Complete abortion requiring no further medical or surgical intervention. [ Time Frame: 7-10 days after intervention ] [ Designated as safety issue: Yes ]
    The clinical assessments of the main outcome are: (i) Physical examination (pulse, blood pressure and temperature); (ii) Pelvic examination that include examination of size of the uterus (External genitalia, speculum examination, Bimanual examination).


Secondary Outcome Measures:
  • Bleeding [ Time Frame: 7-10 days after intervention ] [ Designated as safety issue: Yes ]
    Measurements of pain is conducted using 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.

  • Pain [ Time Frame: 7-10 days after intervention ] [ Designated as safety issue: Yes ]
    Measurements of pain is conducted using symptom diary card used by women to assess daily bleeding and pain. Pain reported using visual analogue scale (VAS) before any use of analgesia.

  • Acceptability [ Time Frame: 7-10 days ] [ Designated as safety issue: Yes ]
    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.

  • Un-scheduled visit [ Time Frame: 7-10 days ] [ Designated as safety issue: Yes ]
    Standardized questionnaires will be used to collect information about time spent on travelling and on clinical visits following treatment.


Other Outcome Measures:
  • Contraceptive uptake [ Time Frame: 7-10 days ] [ Designated as safety issue: No ]
  • Contraceptive uptake [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 979
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Medical Post Abortion Care by Midwife
Women with incomplete abortion is diagnosed and treated with misoprostol by midwife
Other: Medical Post Abortion Care
Women with incomplete abortion is diagnosed and treated with misoprostol
No Intervention: Medical Post Abortion Care by physician
Women with incomplete abortion is diagnosed and treated with misoprostol by physician

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 20 percent could be expected lost to follow up and will be adjusted for. Thus, a total of 979 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 979 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.

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women presenting with vaginal bleeding in the first trimester of pregnancy and diagnosed to have incomplete abortion

Exclusion Criteria:

  • Women with unstable hemodynamic status and shock, signs of sepsis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865136

Contacts
Contact: Marie Klingberg-Allvin, PhD marie.klingberg-allvin@ki.se
Contact: Elisabeth Faxelid, Professor elisabeth.faxelid@ki.se

Locations
Kenya
Jaramogi Oginga Odinga Teaching and Referral Hospital Recruiting
Kisumu, Kenya
Contact: Paul Mitei, MD       miteigyn@gmail.com   
Sub-Investigator: Paul Mitei, MD         
Sponsors and Collaborators
Karolinska Institutet
Kenya Medical Research Institute
University of Nairobi
Investigators
Principal Investigator: Monica Oguttu, Director KMET
  More Information

No publications provided

Responsible Party: Marie Klingberg-Allvin, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01865136     History of Changes
Other Study ID Numbers: PAC 1
Study First Received: May 26, 2013
Last Updated: April 15, 2014
Health Authority: Kenya: Ethical Review Committee

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014