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Overnight dilators for Cervical Dilation

N/A
Waitlist Available
Led By Ila Dayananda
Research Sponsored by Planned Parenthood of Greater New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initiation of d&e procedure to completion of d&e procedure, study day 2
Awards & highlights

Summary

The purpose of this randomized trial is to compare same-day cervical preparation using Dilapan-S™ plus buccal misoprostol to overnight cervical preparation using Dilapan-S™ before D&E at 16.0 to 20.0 weeks. Primary objective: To compare D&E operative time. We hypothesize that same-day Dilapan-S™ plus buccal misoprostol is non-inferior to overnight Dilapan-S™ with respect to operative time. Secondary objectives: To compare treatment groups for the following: Pre-operative cervical dilation; need for mechanical dilation and ease of dilation if required; ability to complete D&E without further cervical preparation; ease of D&E; complications; pain; side effects; patient and provider satisfaction.

Eligible Conditions
  • Cervical Dilation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of d&e procedure to completion of d&e procedure, study day 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation of d&e procedure to completion of d&e procedure, study day 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Operative time

Trial Design

2Treatment groups
Active Control
Group I: Overnight dilatorsActive Control1 Intervention
Participants will have Dilapan-S cervical dilators placed the day prior to their D&E procedure and will receive buccal placebo pills (vitamin B12) 3 hours prior to D&E.
Group II: Same-day DilatorsActive Control1 Intervention
Participants will have Dilapan-S cervical dilators placed 4-6 hours prior to D&E and will receive 400 mcg buccal misoprostol pills 3 hours prior to D&E.

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Who is running the clinical trial?

Planned Parenthood of Greater New YorkLead Sponsor
7 Previous Clinical Trials
1,483 Total Patients Enrolled
Ila DayanandaPrincipal InvestigatorPlanned Parenthood of Greater New York
~6 spots leftby Aug 2025
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