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Completed

NCT Number: NCT00835731

Misoprostol Versus Dilapan-S for Cervical Preparation

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.

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Key information

Conditions

Cervical Ripening

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E

Other names: Cytotec

Dilapan-S, vitamin B-12

Device

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

Primary outcomes

  1. Cervical Dilation in Women Following Exposure to Either Ripening Agent

    Time frame: 3-4 hours after placement of ripening agent

Secondary outcomes

  1. 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)

  2. Procedure Time for Dilation and Evacuation

    Time frame: 3-4 hours after placement of ripening agent

  3. 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

  4. 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.

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Planned Parenthood League of Massachusetts

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 4, 2009
Registry last updated
Oct 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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