NCT01818414

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

January 16, 2017

Completed
Last Updated

February 28, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

March 21, 2013

Results QC Date

February 22, 2016

Last Update Submit

January 16, 2017

Conditions

Therapeutic Abortion

Keywords

Misoprostol administration & dosageAbortion techniquesAbortion Induced methodsDilatation and Curettage

Outcome Measures

Primary Outcomes (1)

  • Operative Time

    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.

    Day 1 of the study

Secondary Outcomes (4)

  • Patient Pain

    Day 1

  • Number of Participants With Postoperative Satisfaction

    Day 1

  • Number of Providers With Overall Satisfaction

    Day 1

  • Complications

    Day 1

Study Arms (2)

Misoprostol

EXPERIMENTAL

Misoprostol 400 mcg buccal 3 hours prior to D\&E as an adjunct to same-day Dilapan-S.

Drug: Misoprostol

Folic Acid

PLACEBO COMPARATOR

Folic acid 4 mg buccally 3 hours prior to D\&E as an adjunct to same-day Dilapan-S

Drug: Folic Acid

Interventions

MisoprostolDRUG

400 mcg of buccal misoprostol, 3 hours prior to planned D\&E

Also known as: Cytotec
Misoprostol
Folic AcidDRUG

4 mg of buccal folic acid, 3 hours prior to planned D\&E

Also known as: folate, vitamin M, vitamin B9
Folic Acid

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Planned Parenthood of Western Pennsylvania

Pittsburgh, Pennsylvania, 15213, United States

Location

Univeristy of Pittsburgh, Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (7)

  • Edelman AB, Buckmaster JG, Goetsch MF, Nichols MD, Jensen JT. Cervical preparation using laminaria with adjunctive buccal misoprostol before second-trimester dilation and evacuation procedures: a randomized clinical trial. Am J Obstet Gynecol. 2006 Feb;194(2):425-30. doi: 10.1016/j.ajog.2005.08.016.

    PMID: 16458640BACKGROUND

  • Goldberg AB, Drey EA, Whitaker AK, Kang MS, Meckstroth KR, Darney PD. Misoprostol compared with laminaria before early second-trimester surgical abortion: a randomized trial. Obstet Gynecol. 2005 Aug;106(2):234-41. doi: 10.1097/01.AOG.0000168629.17326.00.

    PMID: 16055570BACKGROUND

  • Newmann SJ, Dalve-Endres A, Diedrich JT, Steinauer JE, Meckstroth K, Drey EA. Cervical preparation for second trimester dilation and evacuation. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007310. doi: 10.1002/14651858.CD007310.pub2.

    PMID: 20687085BACKGROUND

  • Fox MC, Hayes JL; Society of Family Planning. Cervical preparation for second-trimester surgical abortion prior to 20 weeks of gestation. Contraception. 2007 Dec;76(6):486-95. doi: 10.1016/j.contraception.2007.09.004. Epub 2007 Nov 9.

    PMID: 18061709BACKGROUND

  • Wilson LC, Meyn LA, Creinin MD. Cervical preparation for surgical abortion between 12 and 18 weeks of gestation using vaginal misoprostol and Dilapan-S. Contraception. 2011 Jun;83(6):511-6. doi: 10.1016/j.contraception.2010.10.004. Epub 2010 Dec 3.

    PMID: 21570547BACKGROUND

  • Patel A, Talmont E, Morfesis J, Pelta M, Gatter M, Momtaz MR, Piotrowski H, Cullins V; Planned Parenthood Federation of America Buccal Misoprostol Waiver Group. Adequacy and safety of buccal misoprostol for cervical preparation prior to termination of second-trimester pregnancy. Contraception. 2006 Apr;73(4):420-30. doi: 10.1016/j.contraception.2005.10.004. Epub 2006 Jan 23.

    PMID: 16531179BACKGROUND

  • Boraas CM, Achilles SL, Cremer ML, Chappell CA, Lim SE, Chen BA. Synthetic osmotic dilators with adjunctive misoprostol for same-day dilation and evacuation: a randomized controlled trial. Contraception. 2016 Nov;94(5):467-472. doi: 10.1016/j.contraception.2016.05.008. Epub 2016 May 27.

    PMID: 27241895RESULT

MeSH Terms

Conditions

Dilatation, Pathologic

Interventions

MisoprostolFolic Acid

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Christy Boraas, MD, MPH
Organization
University of Minnesota
bora0021@umn.edu
612-273-7111

Study Officials

  • Principal Investigator, MD MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 21, 2013

First Posted

March 26, 2013

Study Start

October 1, 2013

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

February 28, 2017

Results First Posted

January 16, 2017

Record last verified: 2017-01

Locations

US(2)