Second Trimester Abortion Clinical Trial
Official title:
Laminaria Compared to Dilapan-S for Cervical Preparation Before Dilation and Evacuation at 18-24 Weeks of Gestation: A Randomized Controlled Trial
Verified date | June 2021 |
Source | Planned Parenthood of Greater New York |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 180 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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™ |
Country | Name | City | State |
---|---|---|---|
United States | Planned Parenthood of New York City | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Planned Parenthood of Greater New York | Society of Family Planning |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
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