Laminaria Compared to Dilapan-S for Cervical Preparation Before Dilation and Evacuation at 18-24 Weeks of Gestation

NCT02033083 | Completed Results DMC

• 1 other identifier: laminariavsdilapan
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective: To study the difference in dilation and evacuation (D\&E) procedure time following overnight cervical preparation with laminaria or Dilapan-S™. The investigators hypothesize procedure time will be less with Dilapan-S™. Secondary objectives: To compare the use of laminaria and Dilapan-S™ for differences in: (1) initial cervical dilation before D\&E; (2) need for mechanical dilation to accomplish D\&E and ease of dilation if required; (3) number of osmotic dilators placed; (4) ability to complete the D\&E procedure without further cervical preparation; (5) complications; (6) pain and other side effects; (7) patient acceptability; and (8) provider acceptability.

Conditions

Second Trimester Abortion

Keywords

abortion; cervical dilation

Outcome Measures

Primary Outcomes (1)

• D&E Procedure Time

  Length of D\&E procedure in minutes

  The primary outcome measure will be assessed on the day of the patient's D&E procedure. (day 2)

Study Arms (2)

Laminaria

ACTIVE COMPARATOR

Patients in this arm will receive laminaria cervical dilators one day before D\&E procedure.

Device: Laminaria

Dilapan-S

ACTIVE COMPARATOR

Patients in this arm will receive Dilapan-S cervical dilators one day before D\&E procedure.

Device: Dilapan-S

Interventions

Laminaria DEVICE

Laminaria

Dilapan-S DEVICE

Dilapan-S

Eligibility Criteria

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

You may qualify if:

• years of age and older
• Seeking pregnancy termination from 18 0/7 to 24 0/7 weeks of gestation
• Eligible for pregnancy termination at Planned Parenthood of New York City
• Able to give informed consent
• English speaking

You may not qualify if:

• Active bleeding or hemodynamically unstable at enrollment
• Signs of chorioamnionitis or clinical infection at enrollment
• Signs of spontaneous labor or cervical insufficiency at enrollment
• Spontaneous intrauterine fetal demise
• Allergy to laminaria or Dilapan-S™

Sponsors & Collaborators

• Planned Parenthood of Greater New York: lead
• Society of Family Planning: collaborator

Study Sites (1)

Planned Parenthood of New York City

New York, New York, 10012, United States

Location

Results Point of Contact

• Title: Director of Clinical Training and Research
• Organization: Planned Parenthood of New York City

ctri@ppnyc.org

212-274-7340

Study Officials

• Principal Investigator

  Planned Parenthood of New York City

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 10, 2014
• Study Start: December 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: July 12, 2021
• Results First Posted: September 12, 2018

Record last verified: 2021-06

Locations

US (1)