Comparison of the Safety and Efficacy of Medical Abortion Provided by Physicians and Midlevel Providers in Nepal

NCT01186302 | Completed

• 1 other identifier: WHO A65550
• Study Type: interventional
• Target: 1,104
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare the safety, effectiveness, and acceptability of medical abortion provided by doctors and midlevel providers in a developing country where doctors are scarce, such as Nepal. This study is the first to evaluate the independent provision of medical abortion by trained nurses and auxiliary nurse midwives compared to doctors by assessing differences in safety, clinical outcomes, case management decision-making, and acceptability. This study provides scientifically valid data on the administration of medical abortion by midlevel providers working independently in a low-resource, developing country setting. The evidence generated by the study will assist policy makers in developing countries interested in expanding safe abortion services by eliminating the legal requirement limiting prescription of medical abortion to doctors where medical abortion is not restricted by law.

Conditions

Medical Abortion

Keywords

medical abortion; Nepal; midlevel providers

Outcome Measures

Primary Outcomes (1)

• Complete abortion

  The primary outcome measure was a successful (complete) abortion, defined as no ongoing pregnancy at clinical examination and no surgical intervention necessary.

  30 days

Secondary Outcomes (1)

• Complications from medical abortion

  30 days

Study Arms (2)

Midlevel provider

OTHER

Patients were assigned to a midlevel provider (arm 1) or to a physician (arm 2) for their abortion.

Other: Type of provider

Physician arm

OTHER

Patients were assigned to a midlevel provider (arm 1) or to a physician (arm 2) for their abortion.

Other: Type of provider

Interventions

Type of provider OTHER

Different types of clinicians have different types of medical training. This study tested whether midlevel providers were as safe and effective in administering medical abortion as doctors. All types of providers underwent the same training in medical abortion and used the same medical abortion regimen.

Midlevel provider; Physician arm

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Before randomization: Gestational age not more than 63 days as estimated by last menstrual period (LMP).
• After randomization: Gestational age not more than 63 days as estimated by abdominal and bimanual pelvic examination.
• Above national age of consent
• Willing to return to the clinic for misoprostol on Day 3 and for a follow-up visit on Day 10 to 14.
• Residence within the geographical area specified for each clinic and no more than one hour from emergency referral services.
• Willing to provide written informed consent to participate in the study and to be randomly assigned to a provider team.
• Able to understand the nature of the study, advice and instructions given by health providers.

You may not qualify if:

• Previous allergic reaction to one of the drugs in the medical abortion regimen
• Known or suspected ectopic pregnancy or undiagnosed adnexal mass
• Inherited porphyria (rare genetic blood diseases)
• Chronic adrenal failure
• Long term corticosteroid therapy
• Haemorrhagic disorder or anticoagulant therapy (blood thinner medications)
• IUD in utero that can not be removed before taking mifepristone
• Previous enrolment in the study (i.e. no repeat abortions; only one abortion per woman in the study)
• Unwilling or unable to return to clinic for follow-up visit.

Sponsors & Collaborators

• World Health Organization: lead
• Center for Research on Environment, Health and Population Activities: collaborator

Study Sites (1)

Center for Research and Environmental Health and Population Activities (CREHPA)

Kathmandu, Nepal

Location

Related Publications (3)

• Warriner IK, Meirik O, Hoffman M, Morroni C, Harries J, My Huong NT, Vy ND, Seuc AH. Rates of complication in first-trimester manual vacuum aspiration abortion done by doctors and mid-level providers in South Africa and Vietnam: a randomised controlled equivalence trial. Lancet. 2006 Dec 2;368(9551):1965-72. doi: 10.1016/S0140-6736(06)69742-0.

  PMID: 17141703 BACKGROUND

• Tamang A, Shah IH, Shrestha P, Warriner IK, Wang D, Thapa K, My Huong NT, Meirik O. Comparative satisfaction of receiving medical abortion service from nurses and auxiliary nurse-midwives or doctors in Nepal: results of a randomized trial. Reprod Health. 2017 Dec 16;14(1):176. doi: 10.1186/s12978-017-0438-7.

  PMID: 29246235 DERIVED

• Warriner IK, Wang D, Huong NT, Thapa K, Tamang A, Shah I, Baird DT, Meirik O. Can midlevel health-care providers administer early medical abortion as safely and effectively as doctors? A randomised controlled equivalence trial in Nepal. Lancet. 2011 Apr 2;377(9772):1155-61. doi: 10.1016/S0140-6736(10)62229-5.

  PMID: 21458058 DERIVED

Study Officials

• Kusum Thapa, MD

  Department of Obstetrics and Gynaecology, Paropakar Maternity and Women Hospital (Maternity Hospital), Kathmandu, Nepal

  PRINCIPAL INVESTIGATOR

• Ina Warriner, PhD

  World Health Organization

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: August 23, 2010
• Study Start: April 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 23, 2010

Record last verified: 2010-08

Locations

NE (1)