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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01818414
Recruitment Status : Terminated (Concerns for safety)
First Posted : March 26, 2013
Results First Posted : January 16, 2017
Last Update Posted : February 28, 2017
Information provided by (Responsible Party):
Christy Boraas, University of Pittsburgh

Brief Summary:

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 or disease Intervention/treatment Phase
Therapeutic Abortion Drug: Misoprostol Drug: Folic Acid Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dilapan-S With Adjunctive Misoprostol for Same-day Second Trimester Dilation and Evacuation: A Randomized Trial
Study Start Date : October 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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")

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

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

  4. Complications [ Time Frame: Day 1 ]
    Incidence of surgical complications related to D&E

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01818414

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
Principal Investigator: Principal Investigator, MD MPH University of Pittsburgh

Publications of Results:
Other Publications:

Responsible Party: Christy Boraas, MD, University of Pittsburgh Identifier: NCT01818414     History of Changes
Other Study ID Numbers: SFPRF-112778
First Posted: March 26, 2013    Key Record Dates
Results First Posted: January 16, 2017
Last Update Posted: February 28, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Growth Substances