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OpenTrials
Completed

NCT Number: NCT00775983

Dilapan Versus Laminaria

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

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Key information

Conditions

Cervical Preparation

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco General Hospital

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laminaria

Device

place device in cervix for dilation

Dilapan-S

Device

Place in cervix for dilation.

Primary outcomes

  1. Procedure Time

    Time frame: Day of procedure

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

Secondary outcomes

  1. Participants Who Experienced Complications or Need for Additional Dilation

    Time frame: Day of procedure

    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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: DvL

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 20, 2008
Registry last updated
Nov 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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