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

Planned Parenthood of Greater New York

Status: Completed

Conditions: Second Trimester Abortion

Treatments: Device: Laminaria; Device: Dilapan-S

Study type: Interventional

Funder types: Other

Identifiers

NCT02033083

laminariavsdilapan

Details and patient eligibility

About

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.

Full description

One hundred eighty women were randomized evenly across treatment arms, stratified by gestational age groups of 18 0/7-20 6/7 (n= 91) and 21 0/7-24 0/7 (n=87). The analytic sample N=173 (laminaria=86, Dilapan=87); 2 cases were removed for post-randomization exclusion and 5 for missing data on one or more outcome variables. Demographic information and results for the primary outcome of procedure time are reported below in tabular form in the results section.

Enrollment: 180 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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™

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 2 patient groups

Laminaria

Active Comparator group

Description:

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

Treatment:

Device: Laminaria

Dilapan-S

Active Comparator group

Description:

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

Treatment:

Device: Dilapan-S