Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks

Stanford University

Status: Completed

Conditions: Abortion, Induced

Treatments: Drug: Mifepristone; Drug: Misoprostol; Drug: Intra-amniotic digoxin; Other: Hygroscopic cervical dilators

Study type: Interventional

Funder types: Other

Identifiers

NCT01615731

SU-05302012-10088

Details and patient eligibility

About

A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require. The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased "total" time as two sets of dilators.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >18 years old
• Viable, Singleton pregnancy
• Voluntarily seeking abortion between 19 and 24wks gestation
• Able to give informed consent and comply with study protocol
• Fluent in English or Spanish

Exclusion criteria

• Allergy to misoprostol or mifepristone

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Two sets of dilators

Active Comparator group

Description:

Two sets of osmotic dilators inserted 1 and 2 days pre-op

Treatment:

Drug: Intra-amniotic digoxin

Other: Hygroscopic cervical dilators

Drug: Misoprostol

Mifepristone plus one set of dilators

Experimental group

Description:

One set of dilators plus mifepristone

Treatment:

Drug: Intra-amniotic digoxin

Other: Hygroscopic cervical dilators

Drug: Misoprostol

Drug: Mifepristone