Misoprostol Treatment of Incomplete Abortion by Midwives and Physicians in Uganda

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Marie Klingberg-Allvin, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01743508
First received: November 29, 2012
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

Uganda is one of the countries with highest fertility rate in the world, 6.7 children per women. It is estimated that 56 percent of all pregnancies are unintended and the contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and induced abortion is illegal. Unsafe abortion is responsible for significant morbidity and mortality among women in Uganda. Almost 40% of admissions to emergency obstetric care units in Uganda due to unsafe abortion is reported and considered high in international comparison. Studies have revealed that trained midlevel providers can deliver safe post abortion care for incomplete abortion and use manual vacuum aspiration. The prostaglandin E1 analogue misoprostol has been shown to be an effective tool in the treatment of incomplete abortions. This option is so far under-used in developing countries, especially outside the larger hospitals and private clinics. One significant limiting factor in providing safe post abortion care is the lack of providers. So far technical training has been mainly limited to physicians. Training of midlevel providers in misoprostol treatment of incomplete abortion will support task shifting in places where doctors are costly and scarce. By evaluating the effectiveness of mid-level providers (midwives); conducting MVA and administering misoprostol treatment of incomplete abortion the project is attempting to contribute to the reduction of maternal mortality and morbidity and safeguard high quality of post-abortion care.

Women with incomplete abortion will be randomly allocated to undergo a clinical assessment and treatment (MVA or misoprostol) either by physician or midwife with safety and efficacy as main outcomes in a RCT carried out in hospital setting in Uganda. Our hypothesis is that there are no significant differences in effectiveness and safety between manual vacuum aspiration and misoprostol treatment of incomplete abortion provided by physicians and midwife.

The involvement of midlevel providers in treatment of incomplete abortion has previously not been systematically evaluated in African health care setting.


Condition Intervention
Incomplete Abortion
Procedure: Misoprostol treatment by midwife

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Misoprostol Treatment of Incomplete Abortion by Midwives and Physicians. A Randomized Control Trial in Uganda

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • complete abortion [ Time Frame: 14-28 days post treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • bleeding [ Time Frame: 14-28 days post treatment ] [ Designated as safety issue: No ]
  • pain [ Time Frame: 14-28 days post treatment ] [ Designated as safety issue: No ]
  • women's experiences of the method and care provided [ Time Frame: 14-28 days post treatment ] [ Designated as safety issue: No ]
  • un-scheduled visits [ Time Frame: 14-28 days post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 994
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Misoprostol by physician
Misoprostol treatment by midwife
Procedure: Misoprostol treatment by midwife
Misoprostol treatment by midwife
Other Name: Misoprostol treatment by midwife
Experimental: Misoprostol by midwife
Misoprostol treatment by midwife
Procedure: Misoprostol treatment by midwife
Misoprostol treatment by midwife
Other Name: Misoprostol treatment by midwife

Detailed Description:

The project concerns a randomised controlled trial (RCT) aiming to determine whether midwives and physicians can perform medical treatment for incomplete abortion equally safely at primary care level. All patients included are women admitted due to incomplete abortion and will undergo clinical examinations and treatment in accordance with standard procedures (Bluhm et al., 2007, WHO, 2010). A total of 880 women seeking with symptoms of incomplete abortion will be included after giving their informed consent and randomised to diagnosis and care provided by either midwives or physicians. The study will be conducted at the National referral hospital (Mulago in Kampala). A coordinating centre will be established at the Mulago Hospital in Kampala in order to monitor the study. Included in the coordinating team physicians will be involved and have the ultimate responsibility for the medical care provided within the study. The coordinating physicians will evaluate and monitor the midwives and physicians performance to safeguard that the care provided is safe and thus do not put women at risk or the health care provider in any legal inconvenience. All health care providers at the study site included will be provided training that follows the structure of Ipas who have updated standardized training modules within abortion and post abortion care which is used internationally. Dr Charles Kiggundu, one of the principal investigators is currently involved in training for providers at national level in Uganda and thus has adequate competence and experience. The health care provider's attitude and communications skill is one core component in the training. The importance of the study and the study procedure will be another important aspect of the training in order to motivate health care providers involved in the care at the selected study sites.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bleeding
  • Contractions during pregnancy

Exclusion Criteria:

  • Known allergy to misoprostol
  • Uterine size more than 12 weeks of gestation
  • Suspected ectopic pregnancy
  • Unstable hemodynamic status and chock
  • Signs of pelvic infection and/or sepsis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743508

Contacts
Contact: Josaphat Byamugisha, MD, PhD byamugisha2001@yahoo.com
Contact: Charles Kiggundu, MD kiggunduc@gmail.com

Locations
Uganda
Mulago Hospital Recruiting
Kampala, Uganda
Contact: Josaphat Byamugisha, MD, PhD    +256772642841    byamugisha2001@yahoo.com   
Principal Investigator: Josaphat Byamugisha, PhD         
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Elisabeth Faxelid, Professor Karolinska Institutet
Principal Investigator: Kristina Gemzell-Danielsson, Professor Karolinska Institutet
  More Information

No publications provided

Responsible Party: Marie Klingberg-Allvin, Researcher, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01743508     History of Changes
Other Study ID Numbers: Sida_2010, ZZK9elifax
Study First Received: November 29, 2012
Last Updated: April 15, 2014
Health Authority: Uganda: Research Ethics Committee

Keywords provided by Karolinska Institutet:
incomplete abortion
misoprostol treatment
midwife
uganda

Additional relevant MeSH terms:
Abortion, Incomplete
Abortion, Spontaneous
Pregnancy Complications
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on August 21, 2014