Medical AbortionNCT01186302
Comparison of the Safety and Efficacy of Medical Abortion Provided by Physicians and Midlevel Providers in Nepal
A study testing Type of provider in people with Medical Abortion, run by World Health Organization at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Medical Abortion
- What is being tested?
- Type of provider
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,104 participants
- Where
- 1 siteNepal
- Study dates
- Apr 2009to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Center for Research and Environmental Health and Population Activities (CREHPA)
Kathmandu
About this study
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.
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.
Read the 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.
- Conditions
- Medical Abortion
- Being tested
- Type of provider
- Keywords
- medical abortion, Nepal, midlevel providers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of providerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Midlevel provider | Other | Patients were assigned to a midlevel provider (arm 1) or to a physician (arm 2) for their abortion. Receives: 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. Receives: Other: Type of provider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete abortion
The primary outcome measure was a successful (complete) abortion, defined as no ongoing pregnancy at clinical examination and no surgical intervention necessary.
Measured: 30 days
Secondary outcomes (1)
Complications from medical abortion
Defined as life-threatening events requiring hospitalization: haemorrhage requiring a blood transfusion, hospitalization (iv fluids, iv antibiotics), or laparatomy for ectopic pregnancies.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startApr 2009
- Primary completionMar 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Medical AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,104 participants (actual)
Sponsor and investigators
- Lead sponsor
- World Health Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Research on Environment, Health and Population Activities
- Investigators
- Kusum Thapa, MD, Principal investigator, Department of Obstetrics and Gynaecology, Paropakar Maternity and Women Hospital (Maternity Hospital), Kathmandu, NepalIna Warriner, PhD, Study director, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186302
- Sponsor's protocol ID
- WHO A65550
- Status last verified
- Aug 2010
- First submitted
- 20 Aug 2010
- Last updated
- 23 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17141703Tamang 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.
PubMed 29246235Warriner 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.
PubMed 21458058
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01186302
- Acronym / sponsor ID
- WHO A65550
- Conditions
- Medical Abortion
- Keywords
- medical abortion, Nepal, midlevel providers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,104 participants (actual)
- Lead sponsor
- World Health OrganizationUniversity, hospital or other
- Collaborators
- Center for Research on Environment, Health and Population Activities
- Study start
- Apr 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midlevel provider | Other | Other: Type of providerPatients were assigned to a midlevel provider (arm 1) or to a physician (arm 2) for their abortion. |
| Physician arm | Other | Other: Type of providerPatients were assigned to a midlevel provider (arm 1) or to a physician (arm 2) for their abortion. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Type of providerDifferent 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. | Other | Midlevel provider, Physician arm |
Primary outcome
Complete abortion
Time frame: 30 days
The primary outcome measure was a successful (complete) abortion, defined as no ongoing pregnancy at clinical examination and no surgical intervention necessary.
1 secondary outcome
Complications from medical abortion
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2010.
- Background: PubMed 17141703Warriner 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.
- Derived from this study: PubMed 29246235Tamang 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.
- Derived from this study: PubMed 21458058Warriner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kusum Thapa, MD principal investigator
Department of Obstetrics and Gynaecology, Paropakar Maternity and Women Hospital (Maternity Hospital), Kathmandu, Nepal
Ina Warriner, PhD study director
World Health Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type of provider in people with Medical Abortion, run by World Health Organization at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete abortion (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186302, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2010.