Misoprostol Treatment of Mid Trimester Incomplete Abortion by Midwives and Doctors in Uganda.
- Conditions
- Incomplete Abortion
- Interventions
- Other: Misoprostol treatment by MidwifeOther: Misoprostol treatment by Doctor
- Registration Number
- NCT03622073
- Lead Sponsor
- Makerere University
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1191
- Vaginal bleeding
- With or without contractions with a uterine size > 12 weeks to < 18 weeks
- History of partial expulsion
- Open cervical os.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Misoprostol treatment by Midwife Misoprostol treatment by Midwife Administration of misoprostol by the midwife and assessment for the primary outcome. Misoprostol treatment by Doctor Misoprostol treatment by Doctor Administration of misoprostol by the doctor and assessment for the primary outcome.
- Primary Outcome Measures
Name Time Method Complete abortion 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 Outcome Measures
Name Time Method Unscheduled visits 14-28 days post treatment Participant presenting at the study site when not expected
Women's acceptability of the post abortion care provider 14-28 days post treatment Acceptability will be positive reporting of treatment experience, recommendation of method to a friend or reuse of same method.
Excessive vaginal bleeding 24 hours from treatment initiation Participant reporting use of more than 3 pads in an hour.
Abdominal Pain 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.
Trial Locations
- Locations (14)
Nakaseke Hospital
🇺🇬Nakaseke, Uganda
Mpigi HC IV
🇺🇬Mpigi, Uganda
Mukono HC IV
🇺🇬Mukono, Uganda
Mityana Hospital
🇺🇬Mityana, Uganda
Kasangati HC IV
🇺🇬Wakiso, Uganda
Kiganda HC IV
🇺🇬Mubende, Uganda
Wakiso HC IV
🇺🇬Wakiso, Uganda
Entebbe Hospital
🇺🇬Entebbe, Uganda
Gombe Hospital
🇺🇬Gombe, Uganda
Kawempe Hospital
🇺🇬Kampala, Uganda
Kayunga Hospital
🇺🇬Kayunga, Uganda
Kawolo Hospital
🇺🇬Lugazi, Uganda
Luwero HC IV
🇺🇬Luwero, Uganda
Masaka Hospital
🇺🇬Masaka, Uganda