NCT01865136

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
890

participants targeted

Target at P75+ for phase_4 pregnancy

Timeline
Completed

Started Sep 2013

Typical duration for phase_4 pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

2.9 years

First QC Date

May 26, 2013

Last Update Submit

August 30, 2016

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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 include examination of size of the uterus (External genitalia, speculum examination, Bimanual examination).

    7-10 days after intervention

Secondary Outcomes (4)

  • Bleeding

    7-10 days after intervention

  • Pain

    7-10 days after intervention

  • Acceptability

    7-10 days

  • Un-scheduled visit

    7-10 days

Other Outcomes (2)

  • Contraceptive uptake

    7-10 days

  • Contraceptive uptake

    3 month

Study Arms (2)

Medical Post Abortion Care by Midwife

OTHER

Women with incomplete abortion is diagnosed and treated with misoprostol by midwife

Other: Medical Post Abortion Care

Medical Post Abortion Care by physician

NO INTERVENTION

Women with incomplete abortion is diagnosed and treated with misoprostol by physician

Interventions

Medical Post Abortion CareOTHER

Women with incomplete abortion is diagnosed and treated with misoprostol

Medical Post Abortion Care by Midwife

Eligibility Criteria

Age15 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Women with unstable hemodynamic status and shock, signs of sepsis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jaramogi Oginga Odinga Teaching and Referral Hospital

Kisumu, Kenya

Location

Related Publications (1)

  • Makenzius M, Oguttu M, Klingberg-Allvin M, Gemzell-Danielsson K, Odero TMA, Faxelid E. Post-abortion care with misoprostol - equally effective, safe and accepted when administered by midwives compared to physicians: a randomised controlled equivalence trial in a low-resource setting in Kenya. BMJ Open. 2017 Oct 10;7(10):e016157. doi: 10.1136/bmjopen-2017-016157.

    PMID: 29018067DERIVED

Study Officials

  • Monica Oguttu, Director

    KMET

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 26, 2013

First Posted

May 30, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 31, 2016

Record last verified: 2016-08

Locations

KE(1)