Same-day Dilapan-S With Adjunctive Misoprostol (DAM)

This study has been terminated.
(Concerns for safety)
Sponsor:
Information provided by (Responsible Party):
Christy Boraas, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01818414
First received: March 21, 2013
Last updated: April 12, 2014
Last verified: April 2014
  Purpose

Cervical preparation before second trimester dilation and evacuation (D&E) reduces risks and complications. Osmotic cervical dilators as well as prostaglandin analogues have been studied for cervical preparation. However, the optimal method for cervical preparation, especially for D&E procedures that occur on the same day as cervical preparation, is not known. This study will investigate misoprostol versus placebo as an adjunct to Dilapan-S for cervical preparation for same-day D&E between 16+0 and 20+6 weeks gestation.

HYPOTHESIS: Administration of 400 µg buccal misoprostol compared to placebo at least 3 hours prior to D&E as an adjunct to cervical preparation with Dilapan-S will decrease operative time for same-day D&E performed between 16+0 and 20+6 weeks.


Condition Intervention
Pregnancy Trimester, Second
Drug: Misoprostol
Drug: Folic Acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dilapan-S With Adjunctive Misoprostol for Same-day Second Trimester Dilation and Evacuation: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Operative Time [ Time Frame: Day 1 of the study ] [ Designated as safety issue: No ]
    The primary outcome will be operative time. Operative time will be measured from initial passage of an instrument into the uterus to start the D&E. The end of operative time will be measured by the removal of the last instrument from the uterus to complete the D&E.


Secondary Outcome Measures:
  • Patient pain [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Pain experience by patient at 2 different timepoints as measured by Visual Analog Scale

  • Patient acceptability [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Patient overall satisfaction with cervical preparation method and D&E experience overall

  • Patient side effects [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Incidence of medication side effects (nausea, cramping, diarrhea) experienced by the patients

  • Provider acceptability [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Provider assessment of ease of mechanical dilation, if necessary, and of overall perceived difficulty with the procedure as well as overall satisfaction with cervical preparation

  • Complications [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Incidence of surgical complications related to D&E


Enrollment: 29
Study Start Date: October 2013
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Misoprostol
Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.
Drug: Misoprostol
Other Name: Cytotec
Placebo Comparator: Folic Acid
Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
Drug: Folic Acid
Other Name: folate, vitamin M, vitamin B9

  Eligibility

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

Inclusion Criteria:

  • Age greater than or equal to 18 years (no upper age limit)
  • Gestational age between 16+0 and 20+6 weeks gestation on day of D&E with confirmation of gestational age by ultrasound
  • Desires D&E for termination of pregnancy or for fetal demise
  • Able to provide written informed consent
  • Able to comply with study procedures
  • English-speaking

Exclusion Criteria:

  • Known allergy or contraindication to misoprostol
  • Pregnancy with a multiple gestation
  • Known bleeding disorder or current anticoagulation therapy (within one month of procedure)
  • Active bleeding or hemodynamically unstable at enrollment
  • Signs of chorioamnionitis or clinical infection at enrollment
  • Signs of spontaneous labor or cervical insufficiency at enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01818414

Locations
United States, Pennsylvania
Univeristy of Pittsburgh Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Planned Parenthood of Western Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
  More Information

Publications:

Responsible Party: Christy Boraas, Clinical Instructor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01818414     History of Changes
Other Study ID Numbers: SFPRF-112778
Study First Received: March 21, 2013
Last Updated: April 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Misoprostol administration & dosage
Abortion techniques
Abortion Induced methods
Dilatation and Curettage

Additional relevant MeSH terms:
Folic Acid
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 15, 2014