Clinical trial NCT01818414: Same-day Dilapan-S With Adjunctive Misoprostol
Official title: Dilapan-S With Adjunctive Misoprostol for Same-day Second Trimester Dilation and Evacuation: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Therapeutic Abortion
Keywords: Misoprostol administration & dosage
Abortion techniques
Abortion Induced methods
Dilatation and Curettage
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Operative Time
timeFrame: Day 1 of the study
Secondary outcomes:
measure: Patient Pain
timeFrame: Day 1
measure: Number of Participants With Postoperative Satisfaction
timeFrame: Day 1
measure: Number of Providers With Overall Satisfaction
timeFrame: Day 1
measure: Complications
timeFrame: Day 1
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Planned Parenthood of Western Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Univeristy of Pittsburgh, Magee-Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Principal Investigator, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1097/01.AOG.0000168629.17326.00.
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.
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. doi: 10.1016/j.contraception.2007.09.004. Epub 2007 Nov 9.
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.
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. doi: 10.1016/j.contraception.2005.10.004. Epub 2006 Jan 23.
citation: 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.