None listed
Conditions
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 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
Study design
Eligibility
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.