24-hour Mifepristone and Buccal Versus Mifepristone and Vaginal Misoprostol for Cervical Preparation for D&E

NCT ID: NCT03134183

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-19
• Study Completion Date: 2017-08-01

Brief 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.

Conditions

Abortion, Second Trimester

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vaginal Misoprostol

Intervention is misoprostol versus placebo 400mcg misoprostol formulated within cocoa butter suppository

Group Type: EXPERIMENTAL

Vaginal Misoprostol

Intervention Type: DRUG

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

Buccal Misoprostol

Intervention is misoprostol versus placebo 400mcg misoprostol formulated within mint flavored powder

Group Type: EXPERIMENTAL

Buccal Misoprostol

Intervention Type: DRUG

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

Interventions

Vaginal Misoprostol

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

Intervention Type: DRUG

Buccal Misoprostol

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

Intervention Type: DRUG

Other Intervention Names

cytotec; cytotec

Eligibility Criteria

Inclusion Criteria

• The study will enroll healthy English or Spanish-speaking women, over 18 years of age, eligible for non-urgent D&E at 16 0/7 weeks to 20 6/7 weeks gestation, confirmed by sonogram, and willing/able to undergo informed consent.

Exclusion Criteria

• Emergent need for D&E, intrauterine infection, fetal demise, molar pregnancy, intolerance, allergy or contraindication to mifepristone or misoprostol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frances Casey, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HM20005740

Identifier Type: -

Identifier Source: org_study_id