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

Stanford University logo

Stanford University

Status

Withdrawn

Conditions

Legally Induced Abortion Without Mention of Complication

Treatments

Drug: Misoprostol
Device: Hygroscopic cervical dilators
Drug: Mifepristone

Study type

Interventional

Funder types

Other

Identifiers

NCT02679092
IRB-36302

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 4 patient groups

Dilapan (14wks 0days-15wks, 6days)
Active Comparator group
Description:
The clinician will place 1 to 2 osmotic cervical dilators (Dilapan-S) (4mm x 65mm) the day before the participant's procedure.
Treatment:
Device: Hygroscopic cervical dilators
Dilapan (16wks 0days-18wks, 6days)
Active Comparator group
Description:
The clinician will place 3 to 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
Treatment:
Device: Hygroscopic cervical dilators
Drug: Misoprostol
Mifepristone (14wks 0days-15wks, 6days)
Experimental group
Description:
The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
Treatment:
Drug: Mifepristone
Drug: Misoprostol
Mifepristone (16wks 0days-18wks, 6days)
Experimental group
Description:
The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
Treatment:
Drug: Mifepristone
Drug: Misoprostol

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems