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

NCT01615731 | Completed Results

• 1 other identifier: SU-05302012-10088
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Mifepristone; Induced Abortion; Dilation and Evacuation; Cervical preparation; Osmotic dilators

Outcome Measures

Primary Outcomes (2)

• Procedure Time

  Measured as time from speculum insertion to removal

  Intraoperative Time

• Total Procedure Time

  Measured at clinic visits and on OR day, over a 3 day period

Secondary Outcomes (6)

• Maximum Cervical Dilation

  Measured intra-operatively

• Adverse Events (EBL)

  Intraoperatively

• Ease of Procedure by Blinded Surgeon

  Measured Immediately after procedure

• Pain Perceived by Patient

  Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)

• Overall Patient Experience

  Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge

Study Arms (2)

Two sets of dilators

ACTIVE COMPARATOR

Two sets of osmotic dilators inserted 1 and 2 days pre-op

Other: Hygroscopic cervical dilators; Drug: Misoprostol; Drug: Intra-amniotic digoxin

Mifepristone plus one set of dilators

EXPERIMENTAL

One set of dilators plus mifepristone

Drug: Mifepristone; Other: Hygroscopic cervical dilators; Drug: Misoprostol; Drug: Intra-amniotic digoxin

Interventions

Mifepristone DRUG

200mg Mifepristone orally

Also known as: Danco, Mifeprex

Mifepristone plus one set of dilators

Hygroscopic cervical dilators OTHER

Dilapan-S osmostic cervical dilators inserted through the internal os

Also known as: Dilapan-S

Mifepristone plus one set of dilators; Two sets of dilators

Misoprostol DRUG

400mcg buccal misoprostol 90 minutes pre-op

Mifepristone plus one set of dilators; Two sets of dilators

Intra-amniotic digoxin DRUG

1mg digoxin administered intra-amniotically \~24 hours pre-op

Mifepristone plus one set of dilators; Two sets of dilators

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 19 and 24wks gestation
• Able to give informed consent and comply with study protocol
• Fluent in English or Spanish

You may not qualify if:

• Allergy to misoprostol or mifepristone

Sponsors & Collaborators

• Stanford University: lead
• Santa Clara Valley Medical Center: collaborator

Study Sites (2)

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Dilatation, Pathologic

Interventions

Mifepristone; Misoprostol

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Failure of randomization with respect to assigning similar numbers of nulliparous women to both groups; inaccurate method for measurement of pre-operative cervical dilation; small size of cohort.

Results Point of Contact

• Title: Principal Investigator
• Organization: Stanford University

gynresearch@stanford.edu

650-497-5175

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 11, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 13, 2024
• Results First Posted: January 26, 2015

Record last verified: 2024-01

Locations

US (2)