Ilana G Dzuba1, Erica Chong2, Curtiss Hannum3, E Steve Lichtenberg4, Elba Margarita Lugo Hernández5, Nguyen Thi Nhu Ngoc6, Ashlesha Patel7, Gulnara Rzayeva8, Patricio Sanhueza Smith9, George Tsertsvadze10, Beverly Winikoff11. 1. Gynuity Health Projects, 220 E. 42nd Street, Suite 710, New York, NY 10017, USA. Electronic address: idzuba@gynuity.org. 2. Gynuity Health Projects, 220 E. 42nd Street, Suite 710, New York, NY 10017, USA. Electronic address: echong@gynuity.org. 3. The Women's Centers, 777 Appletree Street, 7th Floor, Philadelphia, PA 19106, USA. Electronic address: channum@thewomenscenters.com. 4. Family Planning Associates, 659 West Washington Blvd, Chicago, IL 60661, USA. Electronic address: jodotter@aol.com. 5. Clinica Comunitaria Santa Catarina, Calle Nuevo León Mz. 38, Lt. 9., Col. Miguel de la Madrid, Del. Iztapalapa, 09698 Mexico City, Mexico. Electronic address: elbalugohdz@gmail.com. 6. Center for Research and Consultancy on Reproductive Health, 16D Luy Ban Bich, Tan Thoi Hoa, Tan Phu, Ho Chi Minh City, Viet Nam. Electronic address: nhungoccrcrh@gmail.com. 7. John H. Stroger, Jr. Hospital of Cook County, Department of Obstetrics and Gynecology, 1901 W Polk Street, Chicago, IL 60622, USA. Electronic address: apatel2@cookcountyhhs.org. 8. Scientific Research Institute of Obstetrics and Gynecology, Baku 560-th block K. Kazimzadeh str. 118, Azerbaijan. Electronic address: gulnara_rzaeva@rambler.ru. 9. Department of Reproductive Health, Secretariat of Health of Mexico City, Calle Altadena #23, Col. Nápoles, Del. Benito Juárez, 03810 Mexico City, Mexico. Electronic address: patriciosanhueza@prodigy.net.mx. 10. David Gagua Clinic, 2/6 Ljubljana Street, Digomi Masivi, Tbilisi, Georgia. Electronic address: tsertsvadzegogi@yahoo.com. 11. Gynuity Health Projects, 220 E. 42nd Street, Suite 710, New York, NY 10017, USA. Electronic address: bwinikoff@gynuity.org.
Abstract
OBJECTIVES: This open-label non-inferiority study assessed efficacy of a common outpatient medical abortion regimen among people with pregnancies 64-70 days and 71-77 days of gestation. STUDY DESIGN: We defined non-inferiority by a 6% margin of method success. People with intrauterine pregnancies 64-77 days' gestational age by abdominal ultrasound seeking medical abortion at one of eight clinics and met eligibility criteria were offered participation. Consenting participants took mifepristone 200 mg followed 24-48 h later by misoprostol 800 mcg buccally, and returned after one week for provider evaluation and abdominal ultrasound to determine abortion status. Participants recorded medication use, pregnancy expulsion, daily bleeding and pain scores until the one-week follow up. Clinic staff interviewed participants prior to study discharge to assess acceptability. RESULTS: Seven hundred and nineteen participants were enrolled, 393 and 326 in the respective groups. Successful expulsion without surgical intervention was achieved in 92.3% of the earlier gestational age group and 86.7% of the later group (difference in proportions 5.6%, 1-sided 95% CI 9.6). Ongoing pregnancy accounted for 3.6% and 8.7% (p = 0.007) of outcomes, respectively. Participants in the 71-77 day group reported nausea and weakness more frequently. Pain, bleeding and acceptability measures between groups were similar. CONCLUSION: Although the success rate at 71-77 days of gestation was within the non-inferiority margin, we cannot rule out that it is statistically worse than in the previous gestational week. Significantly more ongoing pregnancies in the later group raise concerns about using the regimen at 71-77 days.
OBJECTIVES: This open-label non-inferiority study assessed efficacy of a common outpatient medical abortion regimen among people with pregnancies 64-70 days and 71-77 days of gestation. STUDY DESIGN: We defined non-inferiority by a 6% margin of method success. People with intrauterine pregnancies 64-77 days' gestational age by abdominal ultrasound seeking medical abortion at one of eight clinics and met eligibility criteria were offered participation. Consenting participants took mifepristone 200 mg followed 24-48 h later by misoprostol 800 mcg buccally, and returned after one week for provider evaluation and abdominal ultrasound to determine abortion status. Participants recorded medication use, pregnancy expulsion, daily bleeding and pain scores until the one-week follow up. Clinic staff interviewed participants prior to study discharge to assess acceptability. RESULTS: Seven hundred and nineteen participants were enrolled, 393 and 326 in the respective groups. Successful expulsion without surgical intervention was achieved in 92.3% of the earlier gestational age group and 86.7% of the later group (difference in proportions 5.6%, 1-sided 95% CI 9.6). Ongoing pregnancy accounted for 3.6% and 8.7% (p = 0.007) of outcomes, respectively. Participants in the 71-77 day group reported nausea and weakness more frequently. Pain, bleeding and acceptability measures between groups were similar. CONCLUSION: Although the success rate at 71-77 days of gestation was within the non-inferiority margin, we cannot rule out that it is statistically worse than in the previous gestational week. Significantly more ongoing pregnancies in the later group raise concerns about using the regimen at 71-77 days.
Authors: Elizabeth G Raymond; Daniel Grossman; Alice Mark; Ushma D Upadhyay; Gillian Dean; Mitchell D Creinin; Leah Coplon; Jamila Perritt; Jessica M Atrio; DeShawn Taylor; Marji Gold Journal: Contraception Date: 2020-04-16 Impact factor: 3.375
Authors: Megan A Cohen; Anna M Powell; Jenell S Coleman; Jean M Keller; Alison Livingston; Jean R Anderson Journal: Am J Obstet Gynecol Date: 2020-06-06 Impact factor: 8.661