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: November 21, 2016
Last verified: November 2016
  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
Therapeutic Abortion
Drug: Misoprostol
Drug: Folic Acid

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]
    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 ]
    Change in pain from baseline to immediately preoperatively using a 100-mm Visual Analogue Scale ("100-mm Visual Analogue Scale with 0 indicating "no pain" and 100 indicating "worst pain in my life")

  • Number of Participants With Postoperative Satisfaction [ Time Frame: Day 1 ]
    Patient postoperative satisfaction with cervical preparation method

  • Number of Providers With Overall Satisfaction [ Time Frame: Day 1 ]
    Provider overall satisfaction with cervical preparation

  • Complications [ Time Frame: Day 1 ]
    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
400 mcg of buccal misoprostol, 3 hours prior to planned D&E
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
4 mg of buccal folic acid, 3 hours prior to planned D&E
Other Name: folate, vitamin M, vitamin B9

Detailed Description:

Dilation and evacuation (D&E) is commonly performed for second trimester abortions and management of second trimester intrauterine fetal demise (IUFD). Cervical preparation prior to second trimester D&E increases safety.

Osmotic cervical dilators and prostaglandin analogs are used widely for cervical preparation before second trimester D&E. Osmotic dilators are placed into the cervical canal, radially expand as they absorb moisture and decrease the risk of cervical injury during D&E. Laminaria tents are the most commonly used osmotic dilator for D&E cervical preparation but require N18 h to reach maximum diameter. Dilapan-S®, a synthetic osmotic cervical dilator, has a significant dilation effect 2 h after placement with the majority of expansion occurring in 4-6 h according to the manufacturer.

Misoprostol is the most commonly used pharmacologic cervical preparation for D&E with duration of action between 2 and 4 h after administration. Multiple studies demonstrate the safety of misoprostol before early second trimester abortion. One prospective and four retrospective studies suggest that same-day cervical preparation with Dilapan-S and/or misoprostol for second trimester D&E through 20 weeks is safe and effective. Misoprostol may be less effective when used alone compared to overnight osmotic dilators for cervical preparation later in the second trimester but has adjunctive benefit on cervical dilation and procedure time when used with overnight osmotic dilators between 16 and 24 weeks. The effect appears most pronounced at N19 weeks gestation. No prospective studies have been published examining misoprostol as an adjunct to osmotic dilators for cervical preparation for same-day D&E.

Administration of adjunctive misoprostol with Dilapan-S has the potential to effectively prepare the cervix and decrease operative time for same-day D&E. We compared cervical preparation with Dilapan-S with and without adjunctive buccal misoprostol for same-day D&E between 16 0/7 and 20 6/7 weeks gestation.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Planned Parenthood of Western Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
Univeristy of Pittsburgh, Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Principal Investigator, MD MPH University of Pittsburgh
  More Information

Publications:

Responsible Party: Christy Boraas, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01818414     History of Changes
Other Study ID Numbers: SFPRF-112778 
Study First Received: March 21, 2013
Results First Received: February 22, 2016
Last Updated: November 21, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

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
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Hematinics
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on January 19, 2017