Clinical trial NCT01186302: Comparison of the Safety and Efficacy of Medical Abortion Provided by Physicians and Midlevel Providers in Nepal
Official title: Comparison of the Safety, Efficacy, and Feasibility of Medical Abortion Provided by Physicians and Non-physicians in Nepal: a Randomized Controlled, Equivalence Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Abortion
Keywords: medical abortion
Nepal
midlevel providers
Lead sponsor: World Health Organization
Sponsor class: OTHER
Collaborators: name: Center for Research on Environment, Health and Population Activities
First posted: 2010-08-23
Enrollment: 1104
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Each year, some 210 million women throughout the world become pregnant and nearly one in five chooses to terminate the pregnancy (Singh et al., 2009). Approximately, 22 million pregnancies are terminated unsafely; of these, the vast majority (98%) take place in developing countries (WHO, Forthcoming). Access to safe abortion services is a challenge for many women with unwanted pregnancies in developing countries because of restrictive legislation, a shortage of skilled staff or other barriers.

Non-surgical methods of abortion, known as medical abortion, have been developed that use safe and effective drug-based methods for induced abortion. Prescribing authority is generally limited to doctors, however. As a result, medical abortion remains under-utilized and is often inaccessible for many women in developing countries seeking public sector providers trained in medical abortion in areas where there are no doctors.

Midlevel providers (non-physician clinicians such as nurses and midwives) have the potential to provide accessible, low-cost, and safe abortion services in many countries, especially in the developing world. They are more cost-effective to employ than doctors and often work in areas where doctors are in short supply, providing much needed health services to under-served areas while conserving resources. Training midlevel providers in the independent provision of medical abortion with appropriate referral systems would expand access to safe abortion services to lower levels of the health care system where there is no doctor and complement a global health systems trend towards task-shifting where doctors are costly and scarce (WHO, 2007).

The overall objective of the study is to obtain evidence on the safety and effectiveness of medical abortions performed by government trained and certified midlevel providers and physicians to inform policy makers interested in or committed to expanding and decentralizing medical abortion services.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Complete abortion
timeFrame: 30 days
Secondary outcomes:
measure: Complications from medical abortion
timeFrame: 30 days
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Center for Research and Environmental Health and Population Activities (CREHPA)
Study officials:
affiliation: Department of Obstetrics and Gynaecology, Paropakar Maternity and Women Hospital (Maternity Hospital), Kathmandu, Nepal
name: Kusum Thapa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: World Health Organization
name: Ina Warriner, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.