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

Frances E. Casey, Peggy P. Ye, Jamila D. Perritt, Nilda L. Moreno-Ruiz, Matthew F. Reeves

Research output: Contribution to journalArticle

Abstract

Objective: We evaluated initial cervical dilation with the addition of oral mifepristone to vaginal misoprostol as cervical preparation for same-day. second-trimester dilation and evacuation (D&E). Study design: Women desiring abortion between gestational ages 14. weeks 0. days and 19. weeks 6. days were randomized to 200-mg mifepristone or identical placebo immediately followed by 400-mcg misoprostol vaginally 4-6. h 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 10. mm (SD = 3.0. mm), requiring 48 participants in each arm. Results: Of 100 women enrolled, 96 were randomized and completed the study. Age, race, gestational age (mean 17.4. weeks, SD = 1.3) and parity did not significantly differ. Mean initial Hegar dilation measurements were 11.7 and 10.9. mm in the mifepristone and placebo groups, respectively, with difference of 0.8 [95% CI. =-0.4, 2.0. mm]. We found total procedure times of 11.8 and 13.0. min, respectively (difference of 1.2. min [95% CI. =-2.4, 4.8. min]. Participant and provider perceptions did not differ. All 96 procedures were completed without hemorrhage, cervical laceration or other observed complications. Conclusion: The addition of mifepristone to vaginal misoprostol did not provide a significant increase in cervical dilation compared to misoprostol alone as cervical preparation 4-6. h prior to D&E at 14. weeks through 19. weeks 6. days. Implications: Adding mifepristone for a short interval (4-6. h) did not improve cervical preparation with misoprostol prior to D&E at 14-19. weeks. Future studies should evaluate alternative timing intervals of medications for this purpose.

Original languageEnglish (US)
JournalContraception
DOIs
StateAccepted/In press - Sep 25 2015
Externally publishedYes

Fingerprint

Misoprostol
Mifepristone
Second Pregnancy Trimester
Dilatation
Randomized Controlled Trials
Gestational Age
Placebos
Lacerations
Parity
Hemorrhage

Keywords

  • Abortion
  • Dilation and evacuation
  • Mifepristone
  • Misoprostol

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

A randomized controlled trial evaluating same-day mifepristone and misoprostol compared to misoprostol alone for cervical preparation prior to second-trimester surgical abortion. / Casey, Frances E.; Ye, Peggy P.; Perritt, Jamila D.; Moreno-Ruiz, Nilda L.; Reeves, Matthew F.

In: Contraception, 25.09.2015.

Research output: Contribution to journalArticle

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title = "A randomized controlled trial evaluating same-day mifepristone and misoprostol compared to misoprostol alone for cervical preparation prior to second-trimester surgical abortion",
abstract = "Objective: We evaluated initial cervical dilation with the addition of oral mifepristone to vaginal misoprostol as cervical preparation for same-day. second-trimester dilation and evacuation (D&E). Study design: Women desiring abortion between gestational ages 14. weeks 0. days and 19. weeks 6. days were randomized to 200-mg mifepristone or identical placebo immediately followed by 400-mcg misoprostol vaginally 4-6. h 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 10. mm (SD = 3.0. mm), requiring 48 participants in each arm. Results: Of 100 women enrolled, 96 were randomized and completed the study. Age, race, gestational age (mean 17.4. weeks, SD = 1.3) and parity did not significantly differ. Mean initial Hegar dilation measurements were 11.7 and 10.9. mm in the mifepristone and placebo groups, respectively, with difference of 0.8 [95{\%} CI. =-0.4, 2.0. mm]. We found total procedure times of 11.8 and 13.0. min, respectively (difference of 1.2. min [95{\%} CI. =-2.4, 4.8. min]. Participant and provider perceptions did not differ. All 96 procedures were completed without hemorrhage, cervical laceration or other observed complications. Conclusion: The addition of mifepristone to vaginal misoprostol did not provide a significant increase in cervical dilation compared to misoprostol alone as cervical preparation 4-6. h prior to D&E at 14. weeks through 19. weeks 6. days. Implications: Adding mifepristone for a short interval (4-6. h) did not improve cervical preparation with misoprostol prior to D&E at 14-19. weeks. Future studies should evaluate alternative timing intervals of medications for this purpose.",
keywords = "Abortion, Dilation and evacuation, Mifepristone, Misoprostol",
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AU - Moreno-Ruiz, Nilda L.

AU - Reeves, Matthew F.

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N2 - Objective: We evaluated initial cervical dilation with the addition of oral mifepristone to vaginal misoprostol as cervical preparation for same-day. second-trimester dilation and evacuation (D&E). Study design: Women desiring abortion between gestational ages 14. weeks 0. days and 19. weeks 6. days were randomized to 200-mg mifepristone or identical placebo immediately followed by 400-mcg misoprostol vaginally 4-6. h 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 10. mm (SD = 3.0. mm), requiring 48 participants in each arm. Results: Of 100 women enrolled, 96 were randomized and completed the study. Age, race, gestational age (mean 17.4. weeks, SD = 1.3) and parity did not significantly differ. Mean initial Hegar dilation measurements were 11.7 and 10.9. mm in the mifepristone and placebo groups, respectively, with difference of 0.8 [95% CI. =-0.4, 2.0. mm]. We found total procedure times of 11.8 and 13.0. min, respectively (difference of 1.2. min [95% CI. =-2.4, 4.8. min]. Participant and provider perceptions did not differ. All 96 procedures were completed without hemorrhage, cervical laceration or other observed complications. Conclusion: The addition of mifepristone to vaginal misoprostol did not provide a significant increase in cervical dilation compared to misoprostol alone as cervical preparation 4-6. h prior to D&E at 14. weeks through 19. weeks 6. days. Implications: Adding mifepristone for a short interval (4-6. h) did not improve cervical preparation with misoprostol prior to D&E at 14-19. weeks. Future studies should evaluate alternative timing intervals of medications for this purpose.

AB - Objective: We evaluated initial cervical dilation with the addition of oral mifepristone to vaginal misoprostol as cervical preparation for same-day. second-trimester dilation and evacuation (D&E). Study design: Women desiring abortion between gestational ages 14. weeks 0. days and 19. weeks 6. days were randomized to 200-mg mifepristone or identical placebo immediately followed by 400-mcg misoprostol vaginally 4-6. h 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 10. mm (SD = 3.0. mm), requiring 48 participants in each arm. Results: Of 100 women enrolled, 96 were randomized and completed the study. Age, race, gestational age (mean 17.4. weeks, SD = 1.3) and parity did not significantly differ. Mean initial Hegar dilation measurements were 11.7 and 10.9. mm in the mifepristone and placebo groups, respectively, with difference of 0.8 [95% CI. =-0.4, 2.0. mm]. We found total procedure times of 11.8 and 13.0. min, respectively (difference of 1.2. min [95% CI. =-2.4, 4.8. min]. Participant and provider perceptions did not differ. All 96 procedures were completed without hemorrhage, cervical laceration or other observed complications. Conclusion: The addition of mifepristone to vaginal misoprostol did not provide a significant increase in cervical dilation compared to misoprostol alone as cervical preparation 4-6. h prior to D&E at 14. weeks through 19. weeks 6. days. Implications: Adding mifepristone for a short interval (4-6. h) did not improve cervical preparation with misoprostol prior to D&E at 14-19. weeks. Future studies should evaluate alternative timing intervals of medications for this purpose.

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KW - Dilation and evacuation

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