24-hour Mifepristone and Buccal Versus Mifepristone and Vaginal Misoprostol for Cervical Preparation for D&E
Condition: Abortion, Second Trimester
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to compare mifepristone and buccal misoprostol to mifepristone and vaginal
      misoprostol for cervical preparation for second trimester dilation and evacuation (D&E).
    

Detailed description: 
      Standard of care for cervical preparation prior to second trimester surgical abortion has
      traditionally been a pelvic exam with speculum, a paracervical block with lidocaine, and
      placement of a number of osmotic dilators through the cervical canal. Dilators obtain maximal
      expansion within 4-6 hours and patients experience cramping with this process. This cervical
      preparation allows for a faster procedure for the patient (limiting time for anesthesia) and
      an easier procedure for the provider (decreasing necessity for further dilation, decreasing
      risk of cervical laceration, and decreasing blood loss). Following cervical preparation,
      trained providers use instruments to remove the pregnancy per standard of care. Several
      studies have examined the use of medication (mifepristone and/or misoprostol) to dilate the
      cervix as an alternative to osmotic dilators . Patients prefer medication to dilators as
      medication is associated with less discomfort. Medications alone can achieve adequate
      cervical preparation but the optimal timing and routes of these medications has not been
      sufficiently evaluated.

      The addition of mifepristone, a progesterone antagonist, to a misoprostol regimen has been
      shown to significantly decrease the medication-to-abortion interval in second-trimester
      induction terminations. Vaginal administration has demonstrated improved dilation as compared
      to buccal administration but it is known that patients prefer buccal administration. A
      comparison of mifepristone and vaginal versus mifepristone and buccal misoprostol has not
      been studied prior to second-trimester surgical abortion.

      A review of cervical preparation for second-trimester D&E did not recommend mifepristone and
      misoprostol for cervical priming due to high rates of pre-procedural expulsions. However, the
      primary basis for this conclusion is a trial in which the 48-hour interval between the
      medications accounts for the high out-of-facility expulsion risk. A retrospective cohort of
      over 200 women between 14 and 19 6/7 weeks gestation showed no difference in difficulty of
      cervical dilation for patients receiving mifepristone 24-48 hours misoprostol as compared to
      osmotic dilators prior to surgical abortion. Two out of facility expulsions occurred in the
      mifepristone-misoprostol arms but the timing of medication to expulsion interval is not
      reported.

      More recent studies have limited the timing of mifepristone to 24 hours or less prior to
      procedure. Mifepristone only has been shown to provide adequate cervical dilation as compared
      to osmotic dilators to 16 weeks gestation with noninferiority design to detect a 3-minute
      difference in procedure time. A 24-hour interval between 200mg mifepristone and 400mcg buccal
      misoprostol has been shown as non-inferior to osmotic dilators for total procedure time for
      15-18 week surgical abortions. Mifepristone and one-set of osmotic dilators was found to be
      non-inferior for total procedure time as compared to two sets of osmotic dilators for
      surgical abortion 19-23 6/7 weeks gestation.

      The addition of mifepristone has benefit as a cervical priming agent as an adjunct or
      alternative to osmotic dilators for surgical abortion, but it is not known whether the
      addition of vaginal versus buccal misoprostol changes cervical dilation and thus procedure
      time outcomes.
    

Intervention name(s): Vaginal Misoprostol; Buccal Misoprostol
Intervention type(s): Drug; Drug
Intervention description(s): Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D&E; Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D&E
Other intervention name(s): cytotec; cytotec
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: D&E; dilation and evacuation; abortion; second trimester; mifepristone; misoprostol