Dilapan Versus Laminaria

Cervical Preparation Clinical Trial

— DvL  

Official title:

Same-day Dilapan Versus Overnight Laminaria for Cervical Preparation for Early Second-trimester Surgical Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00775983
• Other study ID #: 1176030877
• Status: Completed
• Phase: N/A
• First received: October 16, 2008
• Last updated: October 18, 2013
• Start date: October 2008
• Est. completion date: December 2009

Study information

• Verified date: October 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a randomized, blinded clinical trial comparing overnight laminaria versus same-day Dilapan for cervical preparation for surgical abortions occurring between fourteen and eighteen weeks gestation. Comparisons will be made between procedure time, need for additional dilation, occurrence of complications, and patient and provider satisfaction.

Hypothesis:

Cervical preparation for surgical abortion, between fourteen and eighteen weeks gestation, with same-day Dilapan is non-inferior to cervical preparation with overnight laminaria within a five-minute difference.

Primary objective:

Determine differences in procedure times

Secondary objectives:

Examine complications, and need for additional dilation between early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnancy between fourteen and eighteen weeks gestation

• Request for elective abortion and certainty of decision to proceed

Exclusion Criteria:

• Incarceration

• Minor status (women younger than eighteen years)

• Allergy to Dilapan or laminaria

• Inability to speak and understand Spanish or English

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Preparation

Intervention

Device:
• laminaria
place device in cervix for dilation
• Dilapan-S
Place in cervix for dilation.

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Time	Procedure time to complete early second-trimester dilation and evacuation (D&E)	Day of procedure	No
Secondary	Participants Who Experienced Complications or Need for Additional Dilation	Any complications, or mechanical dilation required, for early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria	Day of procedure	No