Trial | NCT02708446  Report issue

Title

A Comparison of Sublingual and Buccal Misoprostol Regimens After Mifepristone for Mid-trimester Abortion
A Randomized Controlled Trial to Compare Sublingual and Buccal Misoprostol Regimens After Mifepristone for Termination of Pregnancy 13 - 21 Weeks From Last Menstrual Period (LMP)

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    320
The primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to determine if sublingual route confers an advantage with respect to efficacy and median time to complete abortion.
Eligible women 13-21 weeks gestation who give informed consent will be randomized to receive buccal or sublingual misoprostol. Participants will take 200mg mifepristone and return to the hospital 24 hours later to begin induction with misoprostol. 400mcg misoprostol will be given every 3 hours until the expulsion of the fetus and placenta.
Study Started
May 31
2014
Primary Completion
Dec 31
2016
Anticipated
Study Completion
Dec 31
2016
Anticipated
Last Update
Jul 14
2016
Estimate

Drug Mifepristone

200mg oral mifepristone to both study arms

  • Other names: miropristone, Mifeprex, Mifegyne

Drug Buccal misoprostol

doses of buccal misoprostol every 3 hours beginning 24 hours after mifepristone

  • Other names: cytotec

Drug Sublingual misoprostol

doses of sublingual misoprostol every 3 hours beginning 24 hours after mifepristone

  • Other names: cytotec

Sublingual misoprostol Active Comparator

200mg mifepristone + 400mcg sublingual misoprostol q3h

Buccal misoprostol Active Comparator

200mg mifepristone + 400mcg buccal misoprostol q3h

Criteria 

Inclusion Criteria:

Meet criteria to obtain abortion
Present with closed cervical os and no vaginal bleeding
Live fetus at time of presentation for service
Have no contraindications to study procedures, according to provider
Be able to consent to procedure, either by reading consent document or by having consent document read to her
Be willing to follow study procedures

Exclusion Criteria:

Known previous transmural uterine incision
Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
Any contraindications to vaginal delivery
Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
No Results Posted