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

Abortion, Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615731
• Other study ID #: SU-05302012-10088
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: July 2013

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Induced

Intervention

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
• Intra-amniotic digoxin
1mg digoxin administered intra-amniotically ~24 hours pre-op

Locations

Country	Name	City	State
United States	Santa Clara Valley Medical Center	San Jose	California
United States	Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Santa Clara Valley Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Time	Measured as time from speculum insertion to removal	Intraoperative Time
Primary	Total Procedure Time		Measured at clinic visits and on OR day, over a 3 day period
Secondary	Maximum Cervical Dilation	Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.	Measured intra-operatively
Secondary	Adverse Events (EBL)	One adverse event: Estimated Blood Loss	Intraoperatively
Secondary	Ease of Procedure by Blinded Surgeon	Used a Visual Analogue Scale to determine the ease of procedure by blinded surgeon. The VAS ranges from 0-100. 0 being the easiest procedure the surgeon felt they had every performed and 100 being the most difficult procedure imaginable by the surgeon.	Measured Immediately after procedure
Secondary	Pain Perceived by Patient	Used a Visual Analogue Scale to determine the pain perceived by the patient pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively). The VAS ranges from 0-100. 0 being no pain felt by the patient and 100 being the worst pain imaginable felt by the patient.	Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)
Secondary	Overall Patient Experience	Used a Visual Analogue Scale to determine the patient's overall satisfaction with her experience. The VAS ranges from 0-100. 0 being a worse than expected experience, 50 being what the patient expected and 100 being a better than expected experience.	Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge
Secondary	Adverse Events	uterine perforation, uterine injury, etc.	Intraoperatively and 2 weeks post operatively