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

NCT03622073 | Completed DMC

• 1 other identifier: REC REF 2017-016
• Study Type: interventional
• Target: 1,191
• Locations: 1 country
• Sites: 14

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.

Conditions

Incomplete Abortion

Keywords

Post abortion care; Misoprostol; Second trimester

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Excessive vaginal bleeding

  24 hours from treatment initiation

• Abdominal Pain

  24 hours from treatment initiation

• Unscheduled visits

  14-28 days post treatment

• Women's acceptability of the post abortion care provider

  14-28 days post treatment

Study Arms (2)

Misoprostol treatment by Midwife

EXPERIMENTAL

Administration of misoprostol by the midwife and assessment for the primary outcome.

Other: Misoprostol treatment by Midwife

Misoprostol treatment by Doctor

ACTIVE COMPARATOR

Administration of misoprostol by the doctor and assessment for the primary outcome.

Other: Misoprostol treatment by Doctor

Interventions

Misoprostol treatment by Midwife OTHER

Medical management of incomplete abortion

Misoprostol treatment by Midwife

Misoprostol treatment by Doctor OTHER

Medical management of incomplete abortion

Misoprostol treatment by Doctor

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Vaginal bleeding
• With or without contractions with a uterine size \> 12 weeks to \< 18 weeks
• History of partial expulsion
• Open cervical os.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Makerere University: lead
• Karolinska Institutet: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (14)

Entebbe Hospital

Entebbe, Uganda

Location

Gombe Hospital

Gombe, Uganda

Location

Kawempe Hospital

Kampala, Uganda

Location

Kayunga Hospital

Kayunga, 256, Uganda

Location

Kawolo Hospital

Lugazi, 256, Uganda

Location

Luwero HC IV

Luwero, Uganda

Location

Masaka Hospital

Masaka, Uganda

Location

Mityana Hospital

Mityana, Uganda

Location

Mpigi HC IV

Mpigi, Uganda

Location

Kiganda HC IV

Mubende, 256, Uganda

Location

Mukono HC IV

Mukono, Uganda

Location

Nakaseke Hospital

Nakaseke, Uganda

Location

Kasangati HC IV

Wakiso, 256, Uganda

Location

Wakiso HC IV

Wakiso, 256, Uganda

Location

Related Publications (15)

• Faundes A. Strategies for the prevention of unsafe abortion. Int J Gynaecol Obstet. 2012 Oct;119 Suppl 1:S68-71. doi: 10.1016/j.ijgo.2012.03.021. Epub 2012 Aug 9.

  PMID: 22883917 BACKGROUND

• Sedgh G, Bearak J, Singh S, Bankole A, Popinchalk A, Ganatra B, Rossier C, Gerdts C, Tuncalp O, 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.

  PMID: 27179755 BACKGROUND

• 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.

  BACKGROUND

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

  PMID: 23550324 BACKGROUND

• 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.

  PMID: 27802338 BACKGROUND

• 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.

  PMID: 25660084 BACKGROUND

• 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.

  PMID: 25817472 BACKGROUND

• 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.

  PMID: 26872219 BACKGROUND

• 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. No abstract available.

  PMID: 23870184 BACKGROUND

• 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.

  PMID: 24033985 BACKGROUND

• 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.

  PMID: 23656700 BACKGROUND

• 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.

  PMID: 21450128 BACKGROUND

• Atuhairwe S, Hanson C, Atuyambe L, Byamugisha J, Tumwesigye NM, Ssenyonga R, Gemzell-Danielsson K. Evaluating women's acceptability of treatment of incomplete second trimester abortion using misoprostol provided by midwives compared with physicians: a mixed methods study. BMC Womens Health. 2022 Nov 5;22(1):434. doi: 10.1186/s12905-022-02027-y.

  PMID: 36335344 DERIVED

• Atuhairwe S, Byamugisha J, Kakaire O, Hanson C, Cleeve A, Klingberg-Allvin M, Tumwesigye NM, Gemzell-Danielsson K. Comparison of the effectiveness and safety of treatment of incomplete second trimester abortion with misoprostol provided by midwives and physicians: a randomised, controlled, equivalence trial in Uganda. Lancet Glob Health. 2022 Oct;10(10):e1505-e1513. doi: 10.1016/S2214-109X(22)00312-6. Epub 2022 Aug 26.

  PMID: 36030801 DERIVED

• Atuhairwe S, Byamugisha J, Klingberg-Allvin M, Cleeve A, Hanson C, Tumwesigye NM, Kakaire O, Danielsson KG. Evaluating the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians: study protocol for a randomized controlled equivalence trial. Trials. 2019 Jun 21;20(1):376. doi: 10.1186/s13063-019-3490-5.

  PMID: 31227019 DERIVED

MeSH Terms

Conditions

Abortion, Incomplete

Condition Hierarchy (Ancestors)

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

Study Officials

• Kristina G Danielsson, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Josaphat Byamugisha, PhD

  Makerere University

  PRINCIPAL INVESTIGATOR

• Susan Atuhairwe, MD

  Makerere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: August 9, 2018
• Study Start: August 14, 2018
• Primary Completion: November 16, 2021
• Study Completion: December 16, 2021
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: December 2025 to December 2030

Locations

UG (14)