Misoprostol Versus Dilapan-S for Cervical Preparation

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier:
NCT00835731
First received: February 3, 2009
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Cervical Ripening
Drug: misoprostol
Device: Dilapan-S, vitamin B-12

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Cervical Preparation Before Same-day Second Trimester Abortion With Buccal Misoprostol Versus Dilapan-S: A Randomized Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Planned Parenthood League of Massachusetts:

Primary Outcome Measures:
  • Cervical Dilation in Women Following Exposure to Either Ripening Agent [ Time Frame: 3-4 hours after placement of ripening agent ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ease of Further Mechanical Dilation [ Time Frame: 3-4 hours after placement of ripening agent ] [ Designated as safety issue: No ]
  • Procedure Time for Dilation and Evacuation [ Time Frame: 3-4 hours after placement of ripening agent ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Subject Pain During Ripening [ Time Frame: 3-4 hours after placement of ripening agent ] [ Designated as safety issue: No ]

    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.


  • Subject Pain During Dilation and Evacuation [ Time Frame: 3-4 hours after placement of ripening agent ] [ Designated as safety issue: No ]

    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.


  • Women's Preferences for Cervical Ripening Method [ Time Frame: 5 hours after placement of ripening agent ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
400mcg buccal misoprostol
Drug: misoprostol
400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E
Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835731

Locations
United States, Massachusetts
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Planned Parenthood League of Massachusetts
Society of Family Planning
Investigators
Principal Investigator: Prinicpal Investigator Planned Parenthood League of Massachusetts
  More Information

No publications provided

Responsible Party: Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier: NCT00835731     History of Changes
Other Study ID Numbers: SFP2-3
Study First Received: February 3, 2009
Results First Received: June 13, 2013
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Planned Parenthood League of Massachusetts:
induced abortion
misoprostol
cervical ripening
second trimester abortion
Dilapan-S

Additional relevant MeSH terms:
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Vitamins
Misoprostol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on April 16, 2014