Same-day Dilapan-S With Adjunctive Misoprostol

Pregnancy Trimester, Second Clinical Trial

— DAM  

Official title:

Dilapan-S With Adjunctive Misoprostol for Same-day Second Trimester Dilation and Evacuation: A Randomized Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01818414
• Other study ID #: SFPRF-112778
• Status: Terminated
• Phase: N/A
• First received: March 21, 2013
• Last updated: April 12, 2014
• Start date: October 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy Trimester, Second

Intervention

Drug:
• Misoprostol

• Folic Acid

Locations

Country	Name	City	State
United States	Planned Parenthood of Western Pennsylvania	Pittsburgh	Pennsylvania
United States	Univeristy of Pittsburgh Magee-Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. Epub 2007 Nov 9. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2006 Jan 23. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Patient pain	Pain experience by patient at 2 different timepoints as measured by Visual Analog Scale	Day 1	No
Secondary	Patient acceptability	Patient overall satisfaction with cervical preparation method and D&E experience overall	Day 1	No
Secondary	Patient side effects	Incidence of medication side effects (nausea, cramping, diarrhea) experienced by the patients	Day 1	No
Secondary	Provider acceptability	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	Day 1	No
Secondary	Complications	Incidence of surgical complications related to D&E	Day 1	Yes