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
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: 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:
Misoprostol
Folic Acid
Vitamin B Complex
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Hematinics
Hematologic Agents
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 16, 2014