Incomplete Abortion Clinical Trial
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.
Verified date | March 2022 |
Source | Makerere University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1191 |
Est. completion date | December 16, 2021 |
Est. primary completion date | November 16, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 15 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
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 | Mityana Hospital | Mityana | |
Uganda | Mpigi HC IV | Mpigi | |
Uganda | Kiganda HC IV | Mubende | |
Uganda | Mukono HC IV | Mukono | |
Uganda | Nakaseke Hospital | Nakaseke | |
Uganda | Kasangati HC IV | Wakiso | |
Uganda | Wakiso HC IV | Wakiso |
Lead Sponsor | Collaborator |
---|---|
Makerere University | Karolinska Institutet, London School of Hygiene and Tropical Medicine |
Uganda,
Cleeve A, Byamugisha J, Gemzell-Danielsson K, Mbona Tumwesigye N, Atuhairwe S, Faxelid E, Klingberg-Allvin M. Women's Acceptability of Misoprostol Treatment for Incomplete Abortion by Midwives and Physicians - Secondary Outcome Analysis from a Randomized Controlled Equivalence Trial at District Level in Uganda. PLoS One. 2016 Feb 12;11(2):e0149172. doi: 10.1371/journal.pone.0149172. eCollection 2016. — View Citation
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Faúndes A. Strategies for the prevention of unsafe abortion. Int J Gynaecol Obstet. 2012 Oct;119 Suppl 1:S68-71. Epub 2012 Aug 9. — View Citation
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Klingberg-Allvin M, Cleeve A, Atuhairwe S, Tumwesigye NM, Faxelid E, Byamugisha J, Gemzell-Danielsson K. Comparison of treatment of incomplete abortion with misoprostol by physicians and midwives at district level in Uganda: a randomised controlled equivalence trial. Lancet. 2015 Jun 13;385(9985):2392-8. doi: 10.1016/S0140-6736(14)61935-8. Epub 2015 Mar 27. — View Citation
Mark AG, Edelman A, Borgatta L. Second-trimester postabortion care for ruptured membranes, fetal demise, and incomplete abortion. Int J Gynaecol Obstet. 2015 May;129(2):98-103. doi: 10.1016/j.ijgo.2014.11.011. Epub 2015 Jan 19. Review. — View Citation
Moran M, Ortega J, Hodoglugil NN. Osur et al.'s Implementation of misoprostol for postabortion care in Kenya and Uganda: a qualitative evaluation. Glob Health Action. 2012 Jul 18;6:21786. doi: 10.3402/gha.v6i0.21786. — View Citation
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Prada E, Atuyambe LM, Blades NM, Bukenya JN, Orach CG, Bankole A. Incidence of Induced Abortion in Uganda, 2013: New Estimates Since 2003. PLoS One. 2016 Nov 1;11(11):e0165812. doi: 10.1371/journal.pone.0165812. eCollection 2016. — View Citation
Sedgh G, Bearak J, Singh S, Bankole A, Popinchalk A, Ganatra B, Rossier C, Gerdts C, Tunçalp Ö, Johnson BR Jr, Johnston HB, Alkema L. Abortion incidence between 1990 and 2014: global, regional, and subregional levels and trends. Lancet. 2016 Jul 16;388(10041):258-67. doi: 10.1016/S0140-6736(16)30380-4. Epub 2016 May 11. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete abortion | 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 | Excessive vaginal bleeding | Participant reporting use of more than 3 pads in an hour. | 24 hours from treatment initiation | |
Secondary | Abdominal Pain | 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 | |
Secondary | Unscheduled visits | Participant presenting at the study site when not expected | 14-28 days post treatment | |
Secondary | Women's acceptability of the post abortion care provider | Acceptability will be positive reporting of treatment experience, recommendation of method to a friend or reuse of same method. | 14-28 days post treatment |
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