Misoprostol Versus Dilapan-S for Cervical Preparation

September 20, 2017 updated by: Planned Parenthood League of Massachusetts

Cervical Preparation Before Same-day Second Trimester Abortion With Buccal Misoprostol Versus Dilapan-S: A Randomized Placebo Controlled Trial

The purpose of this study is to compare the dilatory effect of 400 mcg of buccally administered misoprostol to one Dilapan-S rod placed 3-4 hours before abortion by dilation and evacuation in women who are 12 weeks 0 days to 15 weeks 0 days gestation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • 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
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Planned Parenthood League of Massachusetts

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • medically eligible for dilation and evacuation at Planned Parenthood League of Massachusetts
  • gestational age 12 weeks 0 days to 15 weeks 0 days as evaluated by ultrasound
  • proficient in English or Spanish
  • agreeing to study procedures, including randomization and surveys regarding demographics, medical and gynecological history, and assessments of pain and satisfaction

Exclusion Criteria:

  • less than 18 years old
  • cervical or uterine anomaly that the research physician deems may affect the difficulty of dilation or the abortion procedure
  • inflammatory bowel disease
  • contraindication to misoprostol use
  • known intolerance or allergy to misoprostol or Dilapan-S
  • inability to give informed consent

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
400mcg buccal misoprostol
Drug: misoprostol
400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E
Other Names:
  • Cytotec
EXPERIMENTAL: 2
Dilapan-S, control: vitamin B-12 administered sublingually
Device: Dilapan-S, vitamin B-12
One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cervical Dilation in Women Following Exposure to Either Ripening Agent
Time Frame: 3-4 hours after placement of ripening agent
3-4 hours after placement of ripening agent

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report
Time Frame: 3-4 hours after placement of ripening agent

Scale:

None needed (score of 0) Very easy (score 1) Somewhat easy (score of 2) Moderate (score of 3) Somewhat difficult (score of 4) Very difficult (score of 5)
3-4 hours after placement of ripening agent
Procedure Time for Dilation and Evacuation
Time Frame: 3-4 hours after placement of ripening agent
3-4 hours after placement of ripening agent
Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt
Time Frame: 3-4 hours after placement of ripening agent
3-4 hours after placement of ripening agent
Subject Pain During Ripening
Time Frame: 3-4 hours after placement of ripening agent

Measure assesses patient pain during cervical preparation. Pain was assessed after cervical ripening was complete, immediately before D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale:

0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain

Higher values represent a worse outcome.
3-4 hours after placement of ripening agent
Subject Pain During Dilation and Evacuation
Time Frame: 3-4 hours after placement of ripening agent

Measure assesses subject pain during dilation and evacuation. Pain was assessed immediately after the D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale:

0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain

Higher values represent a worse outcome.
3-4 hours after placement of ripening agent
Women's Satisfaction With Cervical Ripening Method
Time Frame: 5 hours after placement of ripening agent

Scale:

1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied
5 hours after placement of ripening agent

Collaborators and Investigators

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

Sponsor

Planned Parenthood League of Massachusetts

Collaborators

Society of Family Planning

Investigators

  • Principal Investigator: Prinicpal Investigator, 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

January 1, 2009

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

February 3, 2009

First Submitted That Met QC Criteria

February 3, 2009

First Posted (ESTIMATE)

February 4, 2009

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2017

Last Update Submitted That Met QC Criteria

September 20, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFP2-3

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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