An equivalence study to test whether safety and efficacy of medical abortion provided by nurses and Ayurveda doctors is equivalent to that provided by trained MBBS doctors.

Expanding the MA provider base in India: Building evidence on the feasibility of provision of abortion by ayurved and homeopathic doctors and nurses

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001338

Enrollment

1225

Registered

2010-10-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Medical Abortion: 200mg Mifipristone orally on Day 1 followed by 400mcg of Misoprostol orally on Day 3 Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Intra uterine pregnancy of 2. Hb ≥ 9gm/dl 3. No medical or gynaecological contraindications 4. 18 years or older (or minors with guardian consent); 5. Living or working near a study site; 6. Willing to return on Day 3 for misoprostol and day 15 for follow up check up; 7. Willingness to provide an address and/or telephone number for purposes of follow-up; 8. Willingness to complete a Home study Card of experiences 9. Willingness to come for a follow up in case of incomplete abortion and extended follow up visit if necessary on Day 21. 10. Willingness to provide consent for participation in the study

Exclusion criteria

Exclusion criteria: 1.Smoking>35years 2.Anaemia?hemoglobin<9gm% 3.Suspected /confirmed ectopic pregnancy / undiagnosed adnexal mass 4. Coagulopathy or women on anticoagulant therapy 5. Chronic adrenal failure or current use of systemic corticosteroids 6. Uncontrolled hypertension with BP >160/100mmHg 7. Cardio-vascular diseases such as angina, valvular disease, arrhythmia 8.Severe renal, liver or respiratory diseases 9. Glaucoma 10. Uncontrolled seizure disorder 11. Allergy or intolerance to mifepristone / misoprostol or other prostaglandins 12. Lives far from the clinic

Design outcomes

Primary

Measure	Time frame
To test the feasibility of expanding the abortion provider base by assessing whether efficacy and safety rates associated with medical abortion provided by non-MBBS providers -- doctors trained in the Ayurveda system of medicine and nurses holding a B.Sc or diploma -- are equivalent to those provided by trained MBBS physicians in similar settings. Primary outcomes are: (a) Failure of the procedure (Method failure) and complications: the proportion of all cases that were accepted into the study who complied with the protocol but experienced incomplete abortion or ongoing pregnancy and underwent MVA to complete their abortion; and post-abortion complication rates (b) ?Potential? failure and ?potential? side-effect rates: the total number of women who were accepted into the study and experienced incomplete abortion or experienced side-effects, respectively, plus the total number of women wrongly classified by the study provider as eligible (ie within 56 days gestation) and subsequently disqualified, as a percentage of all women who continued in the study plus those so disqualified. Timepoint: Not Applicable	—

Measure

Time frame

To test the feasibility of expanding the abortion provider base by assessing whether efficacy and safety rates associated with medical abortion provided by non-MBBS providers -- doctors trained in the Ayurveda system of medicine and nurses holding a B.Sc or diploma -- are equivalent to those provided by trained MBBS physicians in similar settings. Primary outcomes are: (a) Failure of the procedure (Method failure) and complications: the proportion of all cases that were accepted into the study who complied with the protocol but experienced incomplete abortion or ongoing pregnancy and underwent MVA to complete their abortion; and post-abortion complication rates (b) ?Potential? failure and ?potential? side-effect rates: the total number of women who were accepted into the study and experienced incomplete abortion or experienced side-effects, respectively, plus the total number of women wrongly classified by the study provider as eligible (ie within 56 days gestation) and subsequently disqualified, as a percentage of all women who continued in the study plus those so disqualified. Timepoint: Not Applicable

—

Secondary

Measure	Time frame
Secondary outcomes are: (a) Failure to assess GA and abortion status (Assessment failure): the proportion of all clients who underwent two pelvic examinations for whom the study provider?s assessment did not match that of the verifier provider and those for whom the final assessment of abortion status did not match on Day 15/21. (b) Failure to comply (Compliance failure): includes two components: (a) the percentage of women who did not comply with the protocol, that is, did not ingest the misoprostol on schedule, or did not return for follow up at the assigned date and time but either returned at an earlier or later date or could be traced at the given address; and (b) loss to follow up, that is, the percentage of women who received mifepristone but did not return on Day 3 and/or Day 15/21 and could not be followed up at the address provided and the percentage of women who took both mifepristone and misoprostol but did not return on Day 15/21 and could not be followed up at the address provided. (c) the acceptability of medical abortion and provider as assessed by clients in the course of the exit interview; and (d) provider satisfaction and experience. Timepoint: Not Applicable	—

Measure

Time frame

Secondary outcomes are: (a) Failure to assess GA and abortion status (Assessment failure): the proportion of all clients who underwent two pelvic examinations for whom the study provider?s assessment did not match that of the verifier provider and those for whom the final assessment of abortion status did not match on Day 15/21. (b) Failure to comply (Compliance failure): includes two components: (a) the percentage of women who did not comply with the protocol, that is, did not ingest the misoprostol on schedule, or did not return for follow up at the assigned date and time but either returned at an earlier or later date or could be traced at the given address; and (b) loss to follow up, that is, the percentage of women who received mifepristone but did not return on Day 3 and/or Day 15/21 and could not be followed up at the address provided and the percentage of women who took both mifepristone and misoprostol but did not return on Day 15/21 and could not be followed up at the address provided. (c) the acceptability of medical abortion and provider as assessed by clients in the course of the exit interview; and (d) provider satisfaction and experience. Timepoint: Not Applicable

—

Countries

India

Contacts

Public ContactSHIREEN JEJEEBHOY

drnitajha@yahoo.com8294634571

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026

An equivalence study to test whether safety and efficacy of medical abortion provided by nurses and Ayurveda doctors is equivalent to that provided by trained MBBS doctors.

Conditions

Related papers

Interventions

Sponsors

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Contacts

Outcome results