NCT01743508

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 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 post abortion care is the lack of providers. So far technical training has been mainly limited to physicians. 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); conducting MVA and 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. Women with incomplete abortion will be randomly allocated to undergo a clinical assessment and treatment (MVA or misoprostol) either by physician or midwife with safety and efficacy as main outcomes in a RCT carried out in hospital setting in Uganda. Our hypothesis is that there are no significant differences in effectiveness and safety between manual vacuum aspiration and misoprostol treatment of incomplete abortion provided by physicians and midwife. The involvement of midlevel providers in treatment of incomplete abortion has previously not been systematically evaluated in African health care setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
731

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

5.3 years

First QC Date

November 29, 2012

Last Update Submit

August 15, 2017

Conditions

Incomplete Abortion

Keywords

incomplete abortionmisoprostol treatmentmidwifeuganda

Outcome Measures

Primary Outcomes (1)

  • complete abortion

    14-28 days post treatment

Secondary Outcomes (4)

  • bleeding

    14-28 days post treatment

  • pain

    14-28 days post treatment

  • women's experiences of the method and care provided

    14-28 days post treatment

  • un-scheduled visits

    14-28 days post treatment

Study Arms (2)

Misoprostol by physician

ACTIVE COMPARATOR

Misoprostol treatment by midwife

Procedure: Misoprostol treatment by midwife

Misoprostol by midwife

EXPERIMENTAL

Misoprostol treatment by midwife

Procedure: Misoprostol treatment by midwife

Interventions

Misoprostol treatment by midwifePROCEDURE

Misoprostol treatment by midwife

Misoprostol by midwifeMisoprostol by physician

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Bleeding
  • Contractions during pregnancy

You may not qualify if:

  • Known allergy to misoprostol
  • Uterine size more than 12 weeks of gestation
  • Suspected ectopic pregnancy
  • Unstable hemodynamic status and chock
  • Signs of pelvic infection and/or sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulago Hospital

Kampala, Uganda

Location

MeSH Terms

Conditions

Abortion, Incomplete

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Elisabeth Faxelid, Professor

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

  • Kristina Gemzell-Danielsson, Professor

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

November 29, 2012

First Posted

December 6, 2012

Study Start

April 1, 2012

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 18, 2017

Record last verified: 2017-08

Locations

UG(1)