Cervical Preparation Before Dilation and Evacuation

January 27, 2016 updated by: Planned Parenthood League of Massachusetts

Cervical Preparation Before Dilation and Evacuation in the Second Trimester: A Multicenter Randomized Trial Comparing Osmotic Dilators Alone to Dilators Plus Adjunctive Misoprostol or Adjunctive Mifepristone.

The purpose of this research study is to compare three different ways of opening a woman's cervix before her second-trimester surgical abortion.

  • Osmotic dilators: small rods that, when inserted into the cervix, gently expand to open the cervix
  • Osmotic dilators plus mifepristone, a medicine that is swallowed
  • Osmotic dilators plus misoprostol, a medicine that is placed between the cheek and gum

Hypotheses:

  • adding buccal misoprostol 3 hours preoperatively will significantly improve dilation compared to laminaria alone, making procedures faster, easier and safer.
  • adding oral mifepristone at the time of laminaria placement will confer a similar benefit.
  • the efficacy of adjunctive misoprostol and mifepristone will be influenced by gestational age, with women later in gestation having increased efficacy from these agents.
  • significantly more patients who receive adjunctive misoprostol or mifepristone will have adequate initial dilation, fewer will require manual dilation or additional cervical preparation and there will be fewer complications in these arms, although complication rates will be low and we will only be able to detect relatively large differences.
  • patients will prefer to have the procedure done as quickly as possible with as little discomfort as possible, that cervical ripening with adjunctive misoprostol will be associated with more cramping than osmotic dilators alone and that mifepristone will be well tolerated and may not cause more cramping or other side effects than osmotic dilators alone.

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.
300

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 Francisco, California, United States, 94110
        • San Francisco General Hospital
    • Illinois
      • Chicago, Illinois, United States, 60630
        • Family Planning Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • New York
      • New York, New York, United States, 10012
        • Planned Parenthood of New York City
    • Oregon
      • Portland, Oregon, United States, 97210
        • Lovejoy Surgical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee Women's Hospital

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18 years and older
  • Able to give informed consent
  • Medically eligible for outpatient second trimester pregnancy termination at the clinical site
  • English-speaking or Spanish-speaking at sites with ability to obtain informed consent in Spanish

Exclusion Criteria:

  • Active bleeding (>1 pad/hour) or hemodynamically unstable at enrollment
  • Signs of chorioamnionitis or clinical infection at enrollment
  • Signs of spontaneous labor or cervical insufficiency at enrollment
  • Spontaneous intrauterine fetal demise
  • Patient incarcerated
  • Allergy to mifepristone or misoprostol
  • Chronic steroid use or adrenal insufficiency
  • Porphyria
  • Inflammatory bowel disease requiring treatment

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: Triple

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.
Other: Osmotic dilators + placebo (vit c) + placebo (vit B12)
Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.
Device: Osmotic dilators
osmotic dilators on Day 1
Other Names:
  • Dilapan-S
  • laminaria
Other: placebo
placebo for mifepristone, on day 1
Other Names:
  • vitamin C 500 mg
Other: placebo
placebo for misoprostol, on day 2
Other Names:
  • vitamin B12 500 mcg
Active Comparator: Osmotic dilators + placebo (vit c) + misoprostol
Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
Device: Osmotic dilators
osmotic dilators on Day 1
Other Names:
  • Dilapan-S
  • laminaria
Other: placebo
placebo for mifepristone, on day 1
Other Names:
  • vitamin C 500 mg
Other: placebo
placebo for misoprostol, on day 2
Other Names:
  • vitamin B12 500 mcg
Drug: misoprostol
buccal misoprostol 400 mcg on Day 2
Other Names:
  • Cytotec
Active Comparator: Osmotic dilators + mifepristone + placebo (vit B12)
Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
Device: Osmotic dilators
osmotic dilators on Day 1
Other Names:
  • Dilapan-S
  • laminaria
Other: placebo
placebo for mifepristone, on day 1
Other Names:
  • vitamin C 500 mg
Other: placebo
placebo for misoprostol, on day 2
Other Names:
  • vitamin B12 500 mcg
Other: Mifepristone
oral mifepristone 200 mg on Day 1.
Other Names:
  • Mifeprex

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
Operative Time
Time Frame: participants were assessed for the duration of the procedure, an average of 6 minutes
The duration of the D&E procedure was measured with a stopwatch, starting with the first instrument that passes into the uterus and ending when the last instrument is removed from the uterus upon completion of the D&E
participants were assessed for the duration of the procedure, an average of 6 minutes

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
Initial Cervical Dilation
Time Frame: participants were assessed during cervical dilation process, average time of 1 minute
Measured at the time of procedure (immediately before the start of D&E)
participants were assessed during cervical dilation process, average time of 1 minute
Ability to Complete the D&E on the First Attempt
Time Frame: participants were assessed for the duration of the procedure, an average of 6 minutes
Assessed on day of procedure and following day. If the procedure was unable to be completed as planned and the subject had to leave the procedure room and return for another attempt either at a time later the same day or the next day.
participants were assessed for the duration of the procedure, an average of 6 minutes
Need for Mechanical Dilation
Time Frame: participants were assessed for the duration of the procedure, an average of 6 minutes
Assessed on Day of procedure. Assessed immediately after completion of D&E
participants were assessed for the duration of the procedure, an average of 6 minutes
Ease of Mechanical Dilation
Time Frame: participants were assessed for the duration of the procedure, an average of 6 minutes
Number of participants for whom, if additional mechanical dilation was required, it was difficult or very difficult. Assessed on day of procedure. Assessed after completion of D&E
participants were assessed for the duration of the procedure, an average of 6 minutes
Complications From Procedure
Time Frame: assessed immediately after completion of D&E and at 1 week and 1 month post-procedure
Patient having any complication, including hospitalizations transfusions additional unplanned procedures
assessed immediately after completion of D&E and at 1 week and 1 month post-procedure
Chills (Any) After Day 2 Medication Administration
Time Frame: assessed immediately after administration of day 2 medication
chills (any) after Day 2 medication administration
assessed immediately after administration of day 2 medication
Patient Satisfaction With Cervical Prep
Time Frame: patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days
Patients who were very satisfied or satisfied with cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure and just prior to discharge home.
patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days
Physician Satisfaction With Cervical Preparation
Time Frame: physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes
Participants for whom the operating physician reported being satisfied or very satisfied with the cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure.
physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes

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.
Planned Parenthood League of Massachusetts

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.
Society of Family Planning

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: Principal Investigator, MD, MPH, Planned Parenthood League of Massachusetts

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
January 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.
February 1, 2014

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, 2014

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).
December 12, 2012

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.
December 13, 2012

First Posted (Estimate)

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.
December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

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 24, 2016

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 27, 2016

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, 2016

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.
  • 9-500-25.1
  • SFPRF6-MS (Other Grant/Funding Number: Society for Family Planning Research Fund)

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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