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

March 9, 2022 updated by: Makerere University

Safety, Effectiveness and Acceptability of Misoprostol When Administered by Midwives Versus Physicians for Management of Incomplete Mid Trimester Abortion in Uganda: a Randomized Controlled Equivalence Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled equivalence trial (RCT) implemented at eight hospitals and Health centres in Central Uganda will include 1192 eligible women with incomplete abortion of uterine size >12 weeks up to 18 weeks. Following informed consent, each participant will be randomly assigned to undergo a clinical assessment and treatment by either a midwife (intervention arm) or physician (control arm); receive 400mcg of misoprostol administered sublingually 3 hourly up to 5 doses within 24 hours at the health facility until a complete abortion is confirmed. Women who do not achieve a complete abortion within 24 hours will undergo a surgical method of uterine evacuation. Pre-discharge information on danger signs, contraceptive counselling and provision will be done with follow up 14 days later to assess secondary outcomes and acceptability. Analyses will be by Intention-to-Treat (ITT). Background characteristics and outcomes will be presented using descriptive statistics. Differences between groups will be analyzed using risk difference (95% CI) and equivalence established if it lies between the pre-defined range of -5% to +5%. Chi-square test will be used for comparison of outcome and t test used to compare mean values. P-values equal to or lower than 0.05 will be considered statistically significant.

Study Type

Interventional

Enrollment (Actual)

1191

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Entebbe, Uganda
        • Entebbe Hospital
      • Gombe, Uganda
        • Gombe Hospital
      • Kampala, Uganda
        • Kawempe Hospital
      • Kayunga, Uganda, 256
        • Kayunga Hospital
      • Lugazi, Uganda, 256
        • Kawolo Hospital
      • Luwero, Uganda
        • Luwero HC IV
      • Masaka, Uganda
        • Masaka Hospital
      • Mityana, Uganda
        • Mityana Hospital
      • Mpigi, Uganda
        • Mpigi HC IV
      • Mubende, Uganda, 256
        • Kiganda HC IV
      • Mukono, Uganda
        • Mukono HC IV
      • Nakaseke, Uganda
        • Nakaseke Hospital
      • Wakiso, Uganda, 256
        • Kasangati HC IV
      • Wakiso, Uganda, 256
        • Wakiso HC IV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Vaginal bleeding
  • With or without contractions with a uterine size > 12 weeks to < 18 weeks
  • History of partial expulsion
  • Open cervical os.

Exclusion Criteria:

  • Known allergy to misoprostol,
  • Unstable hemodynamic status (systolic blood pressure < 90mmHg) and shock
  • Signs of pelvic infection and/or sepsis
  • Previous caesarean delivery/uterine scar
  • Suspected extra uterine pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Misoprostol treatment by Midwife
Administration of misoprostol by the midwife and assessment for the primary outcome.
Other: Misoprostol treatment by Midwife
Medical management of incomplete abortion
Active Comparator: Misoprostol treatment by Doctor
Administration of misoprostol by the doctor and assessment for the primary outcome.
Other: Misoprostol treatment by Doctor
Medical management of incomplete abortion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete abortion
Time Frame: 24 hours from treatment initiation
Number of participants who will have expelled all the products of conception as evidenced by cessation of abdominal cramps, vaginal bleeding and closed cervical os.
24 hours from treatment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Excessive vaginal bleeding
Time Frame: 24 hours from treatment initiation
Participant reporting use of more than 3 pads in an hour.
24 hours from treatment initiation
Abdominal Pain
Time Frame: 24 hours from treatment initiation
Pain will be defined as discomfort experienced in the lower abdomen using a visual analogue scale with a minimum score of zero representing no pain and a maximum score of 10 representing most pain. A higher score represents a worse outcome.
24 hours from treatment initiation
Unscheduled visits
Time Frame: 14-28 days post treatment
Participant presenting at the study site when not expected
14-28 days post treatment
Women's acceptability of the post abortion care provider
Time Frame: 14-28 days post treatment
Acceptability will be positive reporting of treatment experience, recommendation of method to a friend or reuse of same method.
14-28 days post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makerere University

Collaborators

London School of Hygiene and Tropical Medicine
Karolinska Institutet

Investigators

  • Principal Investigator: Kristina G Danielsson, PhD, Karolinska Institutet
  • Principal Investigator: Josaphat Byamugisha, PhD, Makerere University
  • Principal Investigator: Susan Atuhairwe, MD, Makerere University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2018

Primary Completion (Actual)

November 16, 2021

Study Completion (Actual)

December 16, 2021

Study Registration Dates

First Submitted

June 19, 2018

First Submitted That Met QC Criteria

August 4, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 11, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC REF 2017-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be available on request for systematic reviews. The particular data shared will depend on the request.

IPD Sharing Time Frame

December 2025 to December 2030

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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