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Can nurses offer early medical abortion as safely and effectively as physicians? A randomized controlled non-inferiority trial in Mexico City public legal abortion sites.

Can nurses complete medical abortions in women with a gestational age of 70 days or less as safely and effectively as physicians?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001230741
Enrollment
932
Registered
2013-11-08
Start date
2012-09-07
Completion date
2012-12-14
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Currently in Mexico City, medical abortion (MA) is only administered by physicians. Our study examines the effectiveness, safety, and acceptability of nurse-led provision of MA in comparison to that by physicians. The outcome of interest was completed medical abortion without the need for surgical intervention. The outcome was analyzed by intention-to-treat and per-protocol. A total of 932 women participated, 461 in the nurse-led arm and 471 in the physician-led arm. The study found that nurse-led provision of MA is no less safe, acceptable or effective as those led by physicians in Mexico City.

Interventions

The allocated provider for the intervention group were nurses. On day 1 clinical care and initiation of medical abortions (MA) from their allocated provider (nurses or physicians) began. This included counseling, a vaginal/pelvic exam, an abdominal ultrasound, and dispensation of 200mg of oral mifepristone taken on-site under provider supervision. Women were then given 800 micro grams of misoprostol (in 4 tablets of 200 micro grams each) with instructions to self –administer them buccally at h

The allocated provider for the intervention group were nurses. On day 1 clinical care and initiation of medical abortions (MA) from their allocated provider (nurses or physicians) began. This included counseling, a vaginal/pelvic exam, an abdominal ultrasound, and dispensation of 200mg of oral mifepristone taken on-site under provider supervision. Women were then given 800 micro grams of misoprostol (in 4 tablets of 200 micro grams each) with instructions to self –administer them buccally at home, 24 hours after the site visit. As part of the counseling women received on day 1, participants were provided with a card with instructions for contacting a study representative in the event of any questions or concerns, and were given an flyer containing information on expected side effects and also of potential serious events hat may require prompt medical attention, such as heavy bleeding, fever, and abnormal vaginal discharge. During the follow-up visit between days 7-15, abortion completion was assessed through a review of clinical symptoms and bleeding history and an abdominal ultrasound in order to confirm non-pregnancy, both administered by the assigned provider (nurse or phyrsician). When the process was deemed to be not yet complete, participants received an additional dose of 800 micro gramsof misoprostol (to be taken buccally at home) with a request to return for follow up one week later. If providers (nurses and physicians) felt a surgical intervention was warranted or if a woman requested it—a manual vacuum aspiration (MVA) was provided at the same site. All MVA procedures were carried out by an Ob-Gyn specialist, not part of the study.

Sponsors

World Health Organization
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 44 Years
Healthy volunteers
Yes

Inclusion criteria

Eligible participants were women with a gestational age of 70 days or less and selected a medical abortion.

Exclusion criteria

Women with a gestational age of more than 70 days. Women who did not select a medical abortion.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026