Clinical trial NCT00835731: Misoprostol Versus Dilapan-S for Cervical Preparation
Official title: Cervical Preparation Before Same-day Second Trimester Abortion With Buccal Misoprostol Versus Dilapan-S: A Randomized Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Ripening
Keywords: induced abortion
misoprostol
cervical ripening
second trimester abortion
Dilapan-S
Lead sponsor: Planned Parenthood League of Massachusetts
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2009-02-04
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the dilatory effect of 400 mcg of buccally administered misoprostol to one Dilapan-S rod placed 3-4 hours before abortion by dilation and evacuation in women who are 12 weeks 0 days to 15 weeks 0 days gestation.


Eligibility criteria: Inclusion Criteria:

* medically eligible for dilation and evacuation at Planned Parenthood League of Massachusetts
* gestational age 12 weeks 0 days to 15 weeks 0 days as evaluated by ultrasound
* proficient in English or Spanish
* agreeing to study procedures, including randomization and surveys regarding demographics, medical and gynecological history, and assessments of pain and satisfaction

Exclusion Criteria:

* less than 18 years old
* cervical or uterine anomaly that the research physician deems may affect the difficulty of dilation or the abortion procedure
* inflammatory bowel disease
* contraindication to misoprostol use
* known intolerance or allergy to misoprostol or Dilapan-S
* inability to give informed consent

Primary outcomes:
measure: Cervical Dilation in Women Following Exposure to Either Ripening Agent
timeFrame: 3-4 hours after placement of ripening agent
Secondary outcomes:
measure: Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report
timeFrame: 3-4 hours after placement of ripening agent
measure: Procedure Time for Dilation and Evacuation
timeFrame: 3-4 hours after placement of ripening agent
measure: Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt
timeFrame: 3-4 hours after placement of ripening agent
measure: Subject Pain During Ripening
timeFrame: 3-4 hours after placement of ripening agent
measure: Subject Pain During Dilation and Evacuation
timeFrame: 3-4 hours after placement of ripening agent
measure: Women's Satisfaction With Cervical Ripening Method
timeFrame: 5 hours after placement of ripening agent
Other outcomes:
Locations:
city: Boston
country: United States
facility: Planned Parenthood League of Massachusetts
state: Massachusetts
Study officials:
affiliation: Planned Parenthood League of Massachusetts
name: Prinicpal Investigator
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
citation: Bartz D, Maurer R, Allen RH, Fortin J, Kuang B, Goldberg AB. Buccal misoprostol compared with synthetic osmotic cervical dilator before surgical abortion: a randomized controlled trial. Obstet Gynecol. 2013 Jul;122(1):57-63. doi: 10.1097/AOG.0b013e3182983889.