Misoprostol Treatment of Mid Trimester Incomplete Abortion by Midwives and Doctors in Uganda.

Summary

It is estimated that 47,000 women die every year due to consequences of unsafe abortion globally. The majority of pregnancy related deaths occur in low income countries where induced abortion is restricted, unmet need for contraception is high, and women's status is low. Uganda has a high total fertility rate of 5.4 children per woman, low contraceptive prevalence rate of 39%, and more than half of these pregnancies are unintended. Induced abortion is controversial and restricted in Uganda and legally permitted only to save a woman's life. As a result, women often resort to unsafe abortion- that's either performed by a person lacking the necessary skills or in an environment that does not conform to minimal medical standards. Of the estimated 314,304 women who undergo unsafe abortions each year in Uganda, about 41% receive treatment for complications. This equates to an annual rate of 12 per 1,000 women aged 15-49 years being hospitalized for induced abortion complications, which is considered high in international comparison. In Uganda, outside the larger hospitals and private settings, access to safe post abortion care and surgical facilities are scarce. Studies have showed that trained midwives can deliver safe, effective and acceptable post abortion care using misoprostol in the first trimester. Currently in Uganda, treatment of second trimester incomplete abortion is restricted to physicians. This study will provide evidence on whether treatment for incomplete abortion using misoprostol by mid-level providers can be extended to the early second trimester period. The investigators hypothesize that misoprostol treatment for incomplete second trimester abortion provided by midwives is equivalent to that of physicians requiring no further surgical intervention. Women with incomplete abortion will be randomly allocated to undergo a clinical assessment and treatment with misoprostol either by physician or midwife with safety and effectiveness as main outcomes in the RCT carried out in hospital and high volume health centres in Central Uganda.

Conditions

• Incomplete Abortion

Interventions

OTHER

Misoprostol treatment by Midwife

Medical management of incomplete abortion

OTHER

Misoprostol treatment by Doctor

Medical management of incomplete abortion

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Makerere University

  lead OTHER

Principal Investigators

• Kristina G Danielsson, PhD · Karolinska Institutet

• Josaphat Byamugisha, PhD · Makerere University

• Susan Atuhairwe, MD · Makerere University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-14

Primary Completion

2021-11-16

Completion

2021-12-16

Countries

• Uganda

Study Locations