N/A N=180 Randomized Triple-blind Treatment

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

Second Trimester Abortion

Bottom Line

View on ClinicalTrials.gov: NCT02033083 ↗

Enrolled (actual)

180

Serious AEs

0.0%

Results posted

Sep 2018

Primary outcome: Primary: D&E Procedure Time — 7.35; 7.55 minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Laminaria (Device); Dilapan-S (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Planned Parenthood of Greater New York
Primary completion: Feb 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY D&E Procedure Time	7.35; 7.55	—

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.

Eligibility Criteria

Inclusion Criteria

18 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

Exclusion Criteria

• 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™

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02033083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.