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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on August 28, 2014