Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks

Legally Induced Abortion Without Mention of Complication Clinical Trial

Official title:

Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02679092
• Other study ID #: IRB-36302
• Status: Withdrawn
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2020

Study information

• Verified date: September 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dilation and evacuation (D&E) is a common surgical procedure in the U.S. Adequate pre-operative preparation of the uterine cervix is an important part of preventing complications of the procedure. Traditionally, the uterine cervix is prepared for the procedure using water-attracting dilators, which are placed via a speculum exam and cause discomfort for many women. The objective of this study is to investigate the comparative effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for D&E.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: February 2020
• 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 14-19 weeks gestation

• Able to give informed consent and comply with study protocol

• Fluent in English or Spanish

Exclusion Criteria:

• Allergy to study drugs

Related Conditions & MeSH terms

• Legally Induced Abortion Without Mention of Complication

Intervention

Drug:
• Misoprostol
400 mcg buccal 60-90 minutes prior to procedure
• Mifepristone
200 mg PO on the day prior to D&E

Device:
• Hygroscopic cervical dilators
osmotic cervical dilators inserted through the internal os

Locations

Country	Name	City	State
United States	Planned Parenthood Mar Monte	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

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
Secondary	Cervical Dilation	Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure	Baseline
Secondary	Total Procedure Time	All time required by patient (time in clinic for cervical preparation procedures)	Measured at clinic visit and on OR day, over 2 day period
Secondary	Difficulty of Procedure, as reported by clinician	Using Visual Analogue Scale (VAS)	Measured within 5 minutes after procedure
Secondary	Complications/Adverse Events	Estimated blood loss, uterine injury, infection, retained products of conception	Intraoperatively
Secondary	Pain Perceived by Patient	Using Visual Analogue Scale (VAS)	Intraoperatively "Measured during dilator placement"
Secondary	Overall Patient Experience	Using Visual Analogue Scale (VAS)	Measured post-operatively (30 minutes prior to discharge)