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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03622073
• Other study ID #: REC REF 2017-016
• Status: Completed
• Phase: N/A
• Start date: August 14, 2018
• Est. completion date: December 16, 2021

Study information

• Verified date: March 2022
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Abortion, Incomplete
• Incomplete Abortion

Intervention

Other:
• Misoprostol treatment by Midwife
Medical management of incomplete abortion
• Misoprostol treatment by Doctor
Medical management of incomplete abortion

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Makerere University	Karolinska Institutet, London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

Uganda, 

References & Publications (12)

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

Dawson AJ, Buchan J, Duffield C, Homer CS, Wijewardena K. Task shifting and sharing in maternal and reproductive health in low-income countries: a narrative synthesis of current evidence. Health Policy Plan. 2014 May;29(3):396-408. doi: 10.1093/heapol/czt026. Epub 2013 May 8. Review. — View Citation

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

Hussain R. Unintended pregnancy and abortion in Uganda. Issues Brief (Alan Guttmacher Inst). 2013 Jan;(2):1-8. — View Citation

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

Nabudere H, Asiimwe D, Mijumbi R. Task shifting in maternal and child health care: an evidence brief for Uganda. Int J Technol Assess Health Care. 2011 Apr;27(2):173-9. doi: 10.1017/S0266462311000055. Epub 2011 Mar 30. — View Citation

Pongsatha S, Tongsong T. Randomized controlled trial comparing efficacy between a vaginal misoprostol loading and non-loading dose regimen for second-trimester pregnancy termination. J Obstet Gynaecol Res. 2014 Jan;40(1):155-60. doi: 10.1111/jog.12147. Epub 2013 Sep 5. — View Citation

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

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.

* Note: There are 12 references in all — Click here to view all references

Outcome

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

External Links

•   World Health Organization Safe abortion technical and policy guidance for health systems.