NCT01615731

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

Value of Mifepristone in Eliminating the Need for a Second Set of Osmotic Dilators Prior to Dilation and Evacuation Between 19-24 Weeks: A Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Abortion, Induced

Interventions

Type	Name	Description
DRUG	Mifepristone	200mg Mifepristone orally
OTHER	Hygroscopic cervical dilators	Dilapan-S osmostic cervical dilators inserted through the internal os
DRUG	Misoprostol	400mcg buccal misoprostol 90 minutes pre-op
DRUG	Intra-amniotic digoxin	1mg digoxin administered intra-amniotically \~24 hours pre-op

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-06-01
• Completion: 2013-07-01
• First posted: 2012-06-11
• Last updated: 2024-02-13
• Results posted: 2015-01-26

Locations

2 sites across 1 country: United States