A randomized controlled trial evaluating same-day mifepristone and misoprostol compared to misoprostol alone for cervical preparation prior to second-trimester surgical abortion.

MedStar author(s):
Citation: Contraception. 94(2):127-33, 2016 AugPMID: 26948184Institution: MedStar Washington Hospital CenterDepartment: Obstetrics and GynecologyForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Abortifacient Agents, Steroidal/ad [Administration & Dosage] | *Abortion, Induced/mt [Methods] | *Labor Stage, First/de [Drug Effects] | *Mifepristone/ad [Administration & Dosage] | *Misoprostol/ad [Administration & Dosage] | Adolescent | Adult | Female | Gestational Age | Humans | Pregnancy | Pregnancy Trimester, Second | United States | Young AdultYear: 2016Local holdings: Available online from MWHC library: 1995 - presentISSN:
  • 0010-7824
Name of journal: ContraceptionAbstract: CONCLUSION: The addition of mifepristone to vaginal misoprostol did not provide a significant increase in cervical dilation compared to misoprostol alone as cervical preparation 4-6h prior to D&E at 14weeks through 19weeks 6days.Copyright (c) 2016 Elsevier Inc. All rights reserved.IMPLICATIONS: Adding mifepristone for a short interval (4-6h) did not improve cervical preparation with misoprostol prior to D&E at 14-19weeks. Future studies should evaluate alternative timing intervals of medications for this purpose.OBJECTIVE: We evaluated initial cervical dilation with the addition of oral mifepristone to vaginal misoprostol as cervical preparation for same-daysecond-trimester dilation and evacuation (D&E).RESULTS: Of 100 women enrolled, 96 were randomized and completed the study. Age, race, gestational age (mean 17.4weeks, SD=1.3) and parity did not significantly differ. Mean initial Hegar dilation measurements were 11.7 and 10.9mm in the mifepristone and placebo groups, respectively, with difference of 0.8 [95% CI=-0.4, 2.0mm]. We found total procedure times of 11.8 and 13.0min, respectively (difference of 1.2min [95% CI=-2.4, 4.8min]. Participant and provider perceptions did not differ. All 96 procedures were completed without hemorrhage, cervical laceration or other observed complications.STUDY DESIGN: Women desiring abortion between gestational ages 14weeks 0days and 19weeks 6days were randomized to 200-mg mifepristone or identical placebo immediately followed by 400-mcg misoprostol vaginally 4-6h prior to D&E. Primary outcome was cervical dilation assessed by largest Hegar dilator passed without resistance. Secondary outcomes included total procedure time and participant and provider perceptions. We had 90% power to detect a 2-mm change in initial cervical dilation with a mean of 10mm (SD=3.0mm), requiring 48 participants in each arm.All authors: Casey FE, Moreno-Ruiz NL, Perritt JD, Reeves MF, Ye PPFiscal year: FY2017Digital Object Identifier: Date added to catalog: 2017-05-24
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 26948184 Available 26948184

Available online from MWHC library: 1995 - present

CONCLUSION: The addition of mifepristone to vaginal misoprostol did not provide a significant increase in cervical dilation compared to misoprostol alone as cervical preparation 4-6h prior to D&E at 14weeks through 19weeks 6days.

Copyright (c) 2016 Elsevier Inc. All rights reserved.

IMPLICATIONS: Adding mifepristone for a short interval (4-6h) did not improve cervical preparation with misoprostol prior to D&E at 14-19weeks. Future studies should evaluate alternative timing intervals of medications for this purpose.

OBJECTIVE: We evaluated initial cervical dilation with the addition of oral mifepristone to vaginal misoprostol as cervical preparation for same-daysecond-trimester dilation and evacuation (D&E).

RESULTS: Of 100 women enrolled, 96 were randomized and completed the study. Age, race, gestational age (mean 17.4weeks, SD=1.3) and parity did not significantly differ. Mean initial Hegar dilation measurements were 11.7 and 10.9mm in the mifepristone and placebo groups, respectively, with difference of 0.8 [95% CI=-0.4, 2.0mm]. We found total procedure times of 11.8 and 13.0min, respectively (difference of 1.2min [95% CI=-2.4, 4.8min]. Participant and provider perceptions did not differ. All 96 procedures were completed without hemorrhage, cervical laceration or other observed complications.

STUDY DESIGN: Women desiring abortion between gestational ages 14weeks 0days and 19weeks 6days were randomized to 200-mg mifepristone or identical placebo immediately followed by 400-mcg misoprostol vaginally 4-6h prior to D&E. Primary outcome was cervical dilation assessed by largest Hegar dilator passed without resistance. Secondary outcomes included total procedure time and participant and provider perceptions. We had 90% power to detect a 2-mm change in initial cervical dilation with a mean of 10mm (SD=3.0mm), requiring 48 participants in each arm.

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