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NCT Number: NCT03622073

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

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.

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Key information

Conditions

Incomplete Abortion Abortion, Incomplete Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Entebbe Hospital, Entebbe, Uganda

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Misoprostol treatment by Midwife

Other

Medical management of incomplete abortion

Misoprostol treatment by Doctor

Other

Medical management of incomplete abortion

Primary outcomes

  1. 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.

Secondary outcomes

  1. Excessive vaginal bleeding

    Time frame: 24 hours from treatment initiation

    Participant reporting use of more than 3 pads in an hour.

  2. 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.

  3. Unscheduled visits

    Time frame: 14-28 days post treatment

    Participant presenting at the study site when not expected

  4. 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.

Sponsors and collaborators

Lead sponsor

Makerere University

Other

Collaborators

  • Karolinska Institutet
  • London School of Hygiene and Tropical Medicine

Registry information

Official study title

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.

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 9, 2018
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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