Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services (POEM)

January 19, 2024 updated by: Stanford University

Protocol Title: Reducing Complications and Patient Barriers in Second Trimester Abortion: Pre-Operative Effects of Mifepristone (POEM) on Dilatation and Evacuation Services

This research study investigates the use of a drug, mifepristone, given before second trimester abortion. Mifepristone is a medication that is approved for medical abortion during the first trimester. It also has been used prior to abortion in the early seconds trimester (14-16 weeks gestation) and for medication abortion in the second trimester (also called induction abortion). This medication has effects on the uterus that may help dilate, or open, the cervix. Abortion requires opening of the cervix to safely remove the pregnancy. Cervical dilation, or opening, is essential to both ease of completion of procedure and reducing complications that can occur. These complications include laceration, or tearing, of the cervix and perforation of the uterus (a hole made unintentionally in the muscle wall of the uterus) and are not expected to be increased in the study. Dilation of the cervix is usually achieved by placing thin rods (cervical dilators) through the cervix. These rods then absorb the moisture of the vagina and slowly expand, opening the cervix. The standard method of dilation is performed at the clinic and involves the placement of cervical dilators the day before the procedure. This procedure can be uncomfortable. A prior study showed that mifepristone reduces the number of osmotic dilators that need to be placed prior to the procedure after 19 weeks gestation. We aim to investigate mifepristone as a potential adjunct to cervical dilation or used alone, without dilators, as method of cervical preparation with the hopes of reducing barriers imposed by painful procedures and time in clinic and away from work/home that the current approach involving dilators requires.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95128
        • Santa Clara Valley Medical Center
      • Stanford, California, United States, 94305
        • Stanford University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • >18 years old
  • Viable, Singleton pregnancy
  • Voluntarily seeking abortion between 19 and 24 wks gestation
  • Able to give informed consent and comply with study protocol
  • Fluent in English or Spanish

Exclusion Criteria:

  • Allergy to misoprostol or mifepristone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Dilapan-Placebo
The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Other: Hygroscopic cervical dilators
Dilapan-S osmotic cervical dilators inserted through the internal os.
Other Names:
  • Dilapan-S
Drug: Misoprostol
400 mcg buccal misoprostol 90 pre-op
Drug: Intra-amniotic digoxin
1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
Active Comparator: Dilapan-Mifepristone
The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Other: Hygroscopic cervical dilators
Dilapan-S osmotic cervical dilators inserted through the internal os.
Other Names:
  • Dilapan-S
Drug: Misoprostol
400 mcg buccal misoprostol 90 pre-op
Drug: Intra-amniotic digoxin
1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
Drug: Mifepristone
200 mcg Mifepristone orally
Other Names:
  • Mifeprex
  • Danco
Experimental: Mifepristone
The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Drug: Misoprostol
400 mcg buccal misoprostol 90 pre-op
Drug: Intra-amniotic digoxin
1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
Drug: Mifepristone
200 mcg Mifepristone orally
Other Names:
  • Mifeprex
  • Danco

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Procedure Time
Time Frame: Intraoperative Time, Collected immediately within procedure
Measured as time from speculum insertion to removal
Intraoperative Time, Collected immediately within procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Intraoperatively and 2 weeks post operatively
Uterine perforation
Intraoperatively and 2 weeks post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Santa Clara Valley Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kate Shaw, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SU-05132013-108659
  • PF-108666 (Other Grant/Funding Number: Packard Foundation)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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