Same-day Dilapan-S With Adjunctive Misoprostol

Summary

Cervical preparation before second trimester dilation and evacuation (D\&E) reduces risks and complications. Osmotic cervical dilators as well as prostaglandin analogues have been studied for cervical preparation. However, the optimal method for cervical preparation, especially for D\&E procedures that occur on the same day as cervical preparation, is not known. This study will investigate misoprostol versus placebo as an adjunct to Dilapan-S for cervical preparation for same-day D\&E between 16+0 and 20+6 weeks gestation. HYPOTHESIS: Administration of 400 µg buccal misoprostol compared to placebo at least 3 hours prior to D\&E as an adjunct to cervical preparation with Dilapan-S will decrease operative time for same-day D\&E performed between 16+0 and 20+6 weeks.

Timeline

Start

2013-10

Primary completion

2014-03

Completion

2014-04

Publications

• Background 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 Feb;194(2):425-30. doi: 10.1016/j.ajog.2005.08.016.
• Background 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 Aug;106(2):234-41. doi: 10.1097/01.AOG.0000168629.17326.00.
• Background Newmann SJ, Dalve-Endres A, Diedrich JT, Steinauer JE, Meckstroth K, Drey EA. Cervical preparation for second trimester dilation and evacuation. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007310. doi: 10.1002/14651858.CD007310.pub2.
• Background Fox MC, Hayes JL; Society of Family Planning. Cervical preparation for second-trimester surgical abortion prior to 20 weeks of gestation. Contraception. 2007 Dec;76(6):486-95. doi: 10.1016/j.contraception.2007.09.004. Epub 2007 Nov 9.
• Background Wilson LC, Meyn LA, Creinin MD. Cervical preparation for surgical abortion between 12 and 18 weeks of gestation using vaginal misoprostol and Dilapan-S. Contraception. 2011 Jun;83(6):511-6. doi: 10.1016/j.contraception.2010.10.004. Epub 2010 Dec 3.
• Background Patel A, Talmont E, Morfesis J, Pelta M, Gatter M, Momtaz MR, Piotrowski H, Cullins V; Planned Parenthood Federation of America Buccal Misoprostol Waiver Group. Adequacy and safety of buccal misoprostol for cervical preparation prior to termination of second-trimester pregnancy. Contraception. 2006 Apr;73(4):420-30. doi: 10.1016/j.contraception.2005.10.004. Epub 2006 Jan 23.
• Results Boraas CM, Achilles SL, Cremer ML, Chappell CA, Lim SE, Chen BA. Synthetic osmotic dilators with adjunctive misoprostol for same-day dilation and evacuation: a randomized controlled trial. Contraception. 2016 Nov;94(5):467-472. doi: 10.1016/j.contraception.2016.05.008. Epub 2016 May 27.

Drugs

Indications

No indication recorded.