Cervical preparation before second trimester dilatation and evacuation: a multicentre randomized trial comparing osmotic dilators alone to dilators plus adjunctive misoprostol or mifepristone
Alisa Goldberg2 ,1, Jennifer Fortin2, E. Steve Lichtenberg7 ,8, Eleanor Drey9 ,10, Gillian Dean11 ,12, Paula Bednarek13 ,14, Beatrice Chen15 ,16, Caryn Dutton3 ,1, Sarah McKetta2, Rie Maurer3, Beverly Winikoff6, Garrett Fitzmaurice5 ,4 1Harvard Medical School, Boston, MA, USA, 2Planned Parenthood Leauge of Massachusetts, Boston, MA, USA, 3Brigham and Women's Hospital, Boston, MA, USA, 4Harvard School of Public Health, Boston, MA, USA, 5McLean Hospital, Belmont, MA, USA, 6Gynuity Health Projects, New York, NY, USA, 7Family Planning Associates, Chicago, IL, USA, 8Northwestern University, Chicago, IL, USA, 9San Francisco General Hospital, San Francisco, CA, USA, 10University of California, San Francisco, San Francisco, CA, USA, 11Planned Parenthood of New York City, New York, NY, USA, 12Mount Sinai School of Medicine, New York, NY, USA, 13Lovejoy Surgical Center, Portland, OR, USA,
14Oregon Health Sciences University, Portland, OR, USA, 15Magee Women's Hospital, Pittsburgh, PA, USA, 16University of Pittsburgh, Pittsburgh, PA, USA - email@example.com
Objectives: To evaluate adjunctive misoprostol or mifepristone versus osmotic dilators alone for cervical preparation before D&E at 16-23+6/7 weeks. Methods: This double-blind, three arm multicenter randomized controlled trial compared osmotic dilators alone, dilators plus 400 mcg of buccal misoprostol 3 hours preoperatively and dilators plus 200 mg of oral mifepristone during dilator placement for D&E. Our primary outcome was operative time. Secondary outcomes included initial cervical dilatation, D&E completion on first attempt, need for mechanical dilatation and complications. Three hundred women were required for 80% power to detect a 2 minute difference in operative time within two cohorts: 16-18 6/7 weeks (N=150) and 19-23 6/7 weeks gestation (N=150). Results: We found no difference in operative time between treatment arms in either gestational cohort. Initial dilatation was greater with misoprostol than dilators alone in the early cohort (2.4 vs. 2.0 cm, p=.007), but similar in the later cohort. More subjects in the dilators alone arm required additional dilatation in the early cohort (35.3% vs. 9.8% misoprostol vs. 14.3% mifepristone, p=.003); but not the later cohort. We found no difference in procedure completion on the first attempt. Provider satisfaction with cervical preparation was highest after mifepristone (71.8% vs. 78.8% vs. 86.8%, p<.0001). The dilators alone arm had more cervical lacerations requiring repair (4% vs. 0 vs. 0, p=.02) and more uterine re-aspirations (4% vs. 1% vs. 2%, p=.05). Conclusions: Although operative time did not differ, there may be some benefit to use of adjunctive misoprostol or mifepristone for cervical preparation before D&E.
Women are seeking abortion at increasingly earlier gestations, with 41% of first trimester patients in the U.S. receiving an abortion at <6 weeks gestation. The efficacy of medical abortion at <6 weeks gestation is not significantly different than at 6-7 weeks, however, seeking abortion very early in gestation increases the likelihood that providers will have difficulty visualizing the pregnancy on ultrasound, the current standard of care in many clinics.
The most serious risk of treating women with an undesired pregnancy with mifepristone and misoprostol without first confirming a diagnosis of intrauterine pregnancy is a missed diagnosis of ectopic pregnancy. Studies suggest an incidence of ectopic pregnancy of 0.2-0.3% among women presenting for medical abortion. Data support the practice of providing mifepristone and misoprostol medical abortion in the setting of undesired pregnancy of unknown location (PUL) using serial serum hcg testing to simultaneously exclude ectopic pregnancy and determine the efficacy of the medical abortion. Guidelines that enable provision of medical abortion in the setting of PUL, when the patient is asymptomatic, low-risk for ectopic and when combined with close follow up to exclude ectopic pregnancy exist to support this service development.
This presentation will review the evidence for providing medical abortion at <6 weeks gestation including in the setting of PUL.