Dilapan Versus Laminaria

NCT00775983 | Completed Results DMC

• 1 other identifier: 1176030877
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cervical Preparation

Outcome Measures

Primary Outcomes (1)

• Procedure Time

  Procedure time to complete early second-trimester dilation and evacuation (D\&E)

  Day of procedure

Secondary Outcomes (1)

• Participants Who Experienced Complications or Need for Additional Dilation

  Day of procedure

Study Arms (2)

laminaria

ACTIVE COMPARATOR

laminaria placed for cervical dilation; usual standard of care in study clinic

Device: laminaria

Dilapan-S

EXPERIMENTAL

experimental treatment

Device: Dilapan-S

Interventions

laminaria DEVICE

place device in cervix for dilation

laminaria

Dilapan-S DEVICE

Place in cervix for dilation.

Dilapan-S

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnancy between fourteen and eighteen weeks gestation
• Request for elective abortion and certainty of decision to proceed

You may not qualify if:

• Incarceration
• Minor status (women younger than eighteen years)
• Allergy to Dilapan or laminaria
• Inability to speak and understand Spanish or English

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (1)

• Newmann SJ, Sokoloff A, Tharyil M, Illangasekare T, Steinauer JE, Drey EA. Same-day synthetic osmotic dilators compared with overnight laminaria before abortion at 14-18 weeks of gestation: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):271-278. doi: 10.1097/AOG.0000000000000080.

  PMID: 24402587 DERIVED

Limitations and Caveats

-inadequate power to compare complications directly between study groups. Procedure time was chosen as a proxy for procedural difficulty and thus potential complications

Results Point of Contact

• Title: Abby Sokoloff
• Organization: UCSF

sokoloffa@obgyn.ucsf.edu

4155140440

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 20, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 14, 2013
• Results First Posted: July 17, 2013

Record last verified: 2013-10

Locations

US (1)