Misoprostol Treatment of Mid Trimester Incomplete Abortion by Midwives and Doctors in Uganda.
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| ClinicalTrials.gov Identifier: NCT03622073 |
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Recruitment Status :
Completed
First Posted : August 9, 2018
Last Update Posted : March 11, 2022
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Sponsor:
Makerere University
Collaborators:
Karolinska Institutet
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Makerere University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Incomplete Abortion | Other: Misoprostol treatment by Midwife Other: Misoprostol treatment by Doctor | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 1191 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Treatment |
| Official 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. |
| Actual Study Start Date : | August 14, 2018 |
| Actual Primary Completion Date : | November 16, 2021 |
| Actual Study Completion Date : | December 16, 2021 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Misoprostol
| Arm | Intervention/treatment |
|---|---|
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Experimental: Misoprostol treatment by Midwife
Administration of misoprostol by the midwife and assessment for the primary outcome.
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Other: Misoprostol treatment by Midwife
Medical management of incomplete abortion |
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Active Comparator: Misoprostol treatment by Doctor
Administration of misoprostol by the doctor and assessment for the primary outcome.
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Other: Misoprostol treatment by Doctor
Medical management of incomplete abortion |
Primary Outcome Measures :
- 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 Outcome Measures :
- Excessive vaginal bleeding [ Time Frame: 24 hours from treatment initiation ]Participant reporting use of more than 3 pads in an hour.
- 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.
- Unscheduled visits [ Time Frame: 14-28 days post treatment ]Participant presenting at the study site when not expected
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622073
Locations
| Uganda | |
| Entebbe Hospital | |
| Entebbe, Uganda | |
| Gombe Hospital | |
| Gombe, Uganda | |
| Kawempe Hospital | |
| Kampala, Uganda | |
| Kayunga Hospital | |
| Kayunga, Uganda, 256 | |
| Kawolo Hospital | |
| Lugazi, Uganda, 256 | |
| Luwero HC IV | |
| Luwero, Uganda | |
| Masaka Hospital | |
| Masaka, Uganda | |
| Mityana Hospital | |
| Mityana, Uganda | |
| Mpigi HC IV | |
| Mpigi, Uganda | |
| Kiganda HC IV | |
| Mubende, Uganda, 256 | |
| Mukono HC IV | |
| Mukono, Uganda | |
| Nakaseke Hospital | |
| Nakaseke, Uganda | |
| Kasangati HC IV | |
| Wakiso, Uganda, 256 | |
| Wakiso HC IV | |
| Wakiso, Uganda, 256 | |
Sponsors and Collaborators
Makerere University
Karolinska Institutet
London School of Hygiene and Tropical Medicine
Investigators
| Principal Investigator: | Kristina G Danielsson, PhD | Karolinska Institutet | |
| Principal Investigator: | Josaphat Byamugisha, PhD | Makerere University | |
| Principal Investigator: | Susan Atuhairwe, MD | Makerere University |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications:
Uganda Bureau of Statistcs (UBOS) and ICF. 2017. Uganda Demographic and Health Survey 2016: Key Indicators Report. Kampala, Uganda: UBOS, and Rockville, Maryland, USA: UBOS and ICF.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Makerere University |
| ClinicalTrials.gov Identifier: | NCT03622073 |
| Other Study ID Numbers: |
REC REF 2017-016 |
| First Posted: | August 9, 2018 Key Record Dates |
| Last Update Posted: | March 11, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Deidentified data will be available on request for systematic reviews. The particular data shared will depend on the request. |
| Time Frame: | December 2025 to December 2030 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Makerere University:
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Post abortion care Misoprostol Second trimester |
Additional relevant MeSH terms:
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Abortion, Incomplete Abortion, Spontaneous Pregnancy Complications Misoprostol Abortifacient Agents, Nonsteroidal Abortifacient Agents |
Reproductive Control Agents Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Oxytocics |