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Cervical ripening before dilation and evacuation: A multicenter randomized trial comparing laminaria alone to laminaria plus adjunctive misoprostol or adjunctive mifepristone

Alisa Goldberg, Planned Parenthood League of Massachusetts, 2012

Project abstract

Cervical preparation before D&E reduces the risk of cervical laceration and uterine perforation compared to mechanical dilation. (1-2) Laminaria has been the standard method of preoperative cervical preparation for many years.(3) Later in the second trimester, serial laminaria placement provides greater dilation than one-day treatment,(4) yet limited access to second trimester abortion services has led providers to investigate alternatives that act more quickly. Misoprostol is widely used prior to second trimester D&E.(5) Early in the second trimester overnight laminaria provides better dilation than same-day misoprostol.(6) Buccal misoprostol when given 60-90 minutes preoperatively as an adjunct to laminaria does not improve cervical dilation among women 13-19 weeks, but does improve dilation among women 19-20 weeks gestation.(7) Earlier in gestation, misoprostol likely needs longer to work. In the first trimester, misoprostol has no effect on cervical dilation after 60 minutes,(8) yet multiple studies show benefit after 3 hours.(9-10) First trimester cervical preparation studies also suggest mifepristone may be more effective and better tolerated than misoprostol.

We propose a double-blind, three arm randomized controlled trial comparing laminaria alone, laminaria plus buccal misoprostol given 3 hours preoperatively and laminaria plus oral mifepristone given at the time of laminaria placement for women 16 to 23 6/7 weeks gestation undergoing D&E. Our primary outcome is D&E procedure time. Secondary outcomes include comparisons of initial cervical dilation, ability to complete the D&E on the first attempt, need for mechanical dilation and ease of dilation if required, complications, pain, side effects and patient and provider acceptability. We estimate a total of 300 women are required to have 80% power to detect a 2 minute difference in procedure time between the two medication arms and between each medication arm and the placebo group within two cohorts: 16-18 6/7 weeks (N=150) and 19-23 6/7 weeks gestation (N=150).(11-12)

References

  1. Peterson WF, Berry FN, Grace MR, Gulbranson CL. Second-trimester abortion by dilatation and evacuation: an analysis of 11,747 cases. Obstet Gynecol 1983;62:185-90.
  2. Fox MC, Hayes JL. Cervical preparation for second-trimester surgical abortion prior to 20 weeks of gestation. Contraception 2007;76:486-95.
  3. Schneider D, Halperin R, Langer R, Caspi E, Bukovsky I. Abortion at 18-22 weeks by laminaria dilation and evacuation. Obstet Gynecol 1996;88:412-4.
  4. Stubblefield PG, Altman AM, Goldstein SP. Randomized trial of one versus two days of laminaria treatment prior to late midtrimester abortion by uterine evacuation: a pilot study. Am J Obstet Gynecol 1982;143:481-2.
  5. O'Connell K, Jones HE, Lichtenberg ES, Paul M. Second-trimester surgical abortion practices: a survey of National Abortion Federation members. Contraception 2008;78:492-9.
  6. Goldberg AB, Drey EA, Whitaker AK, Kang MS, Meckstroth KR, Darney PD. Misoprostol compared with laminaria before early second-trimester surgical abortion: a randomized trial. Obstet Gynecol 2005;106:234-41.
  7. Edelman AB, Buckmaster JG, Goetsch MF, Nichols MD, Jensen JT. Cervical preparation using laminaria with adjunctive buccal misoprostol before second-trimester dilation and evacuation procedures: a randomized clinical trial. Am J Obstet Gynecol 2006;194:425-30.
  8. Sharma S, Refaey H, Stafford M, Purkayastha S, Parry M, Axby H. Oral versus vaginal misoprostol administered one hour before surgical termination of pregnancy: a randomised controlled trial. BJOG 2005;112:456-60.
  9. Singh K, Fong YF, Prasad RN, Dong F. Evacuation interval after vaginal misoprostol for preabortion cervical priming: a randomized trial. Obstet Gynecol 1999;94:431-4.
  10. Fong YF, Singh K, Prasad RN. A comparative study using two dose regimens (200 microg or 400 microg) of vaginal misoprostol for pre-operative cervical dilatation in first trimester nulliparae. Br J Obstet Gynaecol 1998;105:413-7.
  11. Kapp N, Lohr PA, Ngo TD, Hayes JL. Cervical preparation for first trimester surgical abortion. Cochrane Database Syst Rev 2010:CD007207.
  12. Ashok PW, Flett GM, Templeton A. Mifepristone versus vaginally administered misoprostol for cervical priming before first-trimester termination of pregnancy: a randomized, controlled study. Am J Obstet Gynecol 2000;183:998-1002.

 


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