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

NCT02679092 | Withdrawn

• 1 other identifier: IRB-36302
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Legally Induced Abortion Without Mention of Complication

Keywords

Induced Abortion; Mifepristone; Dilation and Evacuation; Cervical Preparation; Osmotic Dilators; Misoprostol

Outcome Measures

Primary Outcomes (1)

• Procedure Time

  Measured as time from speculum insertion to removal.

  Intraoperative

Secondary Outcomes (6)

• Cervical Dilation

  Baseline

• Total Procedure Time

  Measured at clinic visit and on OR day, over 2 day period

• Difficulty of Procedure, as reported by clinician

  Measured within 5 minutes after procedure

• Complications/Adverse Events

  Intraoperatively

• Pain Perceived by Patient

  Intraoperatively "Measured during dilator placement"

Study Arms (4)

Dilapan (14wks 0days-15wks, 6days)

ACTIVE COMPARATOR

The clinician will place 1 to 2 osmotic cervical dilators (Dilapan-S) (4mm x 65mm) the day before the participant's procedure.

Device: Hygroscopic cervical dilators

Dilapan (16wks 0days-18wks, 6days)

ACTIVE COMPARATOR

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.

Drug: Misoprostol; Device: Hygroscopic cervical dilators

Mifepristone (14wks 0days-15wks, 6days)

EXPERIMENTAL

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.

Drug: Misoprostol; Drug: Mifepristone

Mifepristone (16wks 0days-18wks, 6days)

EXPERIMENTAL

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.

Drug: Misoprostol; Drug: Mifepristone

Interventions

Misoprostol DRUG

400 mcg buccal 60-90 minutes prior to procedure

Also known as: Cytotec

Dilapan (16wks 0days-18wks, 6days); Mifepristone (14wks 0days-15wks, 6days); Mifepristone (16wks 0days-18wks, 6days)

Mifepristone DRUG

200 mg PO on the day prior to D\&E

Also known as: Danco, Mifeprex

Mifepristone (14wks 0days-15wks, 6days); Mifepristone (16wks 0days-18wks, 6days)

Hygroscopic cervical dilators DEVICE

osmotic cervical dilators inserted through the internal os

Also known as: Dilapan-S

Dilapan (14wks 0days-15wks, 6days); Dilapan (16wks 0days-18wks, 6days)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• Allergy to study drugs

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Planned Parenthood Mar Monte

San Jose, California, 95126, United States

Location

MeSH Terms

Conditions

Dilatation, Pathologic

Interventions

Misoprostol; Mifepristone

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Principal Investigator

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 10, 2016
• Study Start: April 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

US (1)