The investigators plan to study the role of mifepristone prior to the placement of cervical osmotic dilators to evaluate if the medication helps increase the number of dilators. This may help improve safety of dilation and evacuation (D\&E) procedures.
No clear guideline currently exists for best practices involving cervical preparation for women planning dilation and evacuation at 20 weeks and greater. The investigators plan to perform a pilot, randomized, double-blind, placebo-controlled trial. On day 1, 66 participants will receive mifepristone 200 mg orally or placebo 18-24 hours prior to osmotic dilator (Dilapan-S 4-mm) placement (day 2). On day 3, participants will have a D\&E procedure. Enrollees will be 18 weeks 0 days to 23 weeks 6 days gestation on the day of the procedure. The primary objective is to evaluate the role of adjunctive mifepristone the day prior to osmotic dilator placement for dilation and evacuation procedures. The primary outcome will be the number of dilators successfully placed. Investigators will compare the number of dilators placed between study arms stratified by gestational age. Secondary outcomes include cervical dilation at time of procedure, proportion of women requiring mechanical dilation at time of surgery, provider impression on ease of procedure and/or difficulty in dilating the cervix when clinically required, and overall complications. Complications or adverse events include cervical laceration requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infection, additional surgical procedures, or extramural deliveries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Ingestion of study medication vs placebo
Ingestion of study medication vs placebo
UC Davis Department of Obstetrics and Gynecology
Sacramento, California, United States
Number of Participants That Had Placement of Expected Dilators or More
The number of expected dilators (Dilapan-S) is calculated based on the gestational age. Four dilators are expected to be placed at 18 weeks 0 days to 19 weeks 6 days gestation. Five dilators are expected to be placed at 20 weeks 0 days to 20 weeks 6 days gestation. Six dilators are expected to be placed at 21 weeks 0 days to 21 weeks 6 days gestation. Seven dilators are expected to be placed at 22 weeks 0 days to 23 weeks 5 days gestation. Therefore, at any given gestational age, if the expected number of dilators (or additional dilators) were placed, the participant was counted as "Yes, participant had placement of expected dilators or more."
Time frame: At time of 1 hour clinic visit (10 minutes)
Cervical Dilation
Measurement of cervical dilation at time of procedure
Time frame: At time of ~1 hour scheduled procedure time (1 minute)
Number of Participants That Required Mechanical Dilation
A count of the number of participants that required of mechanical dilation at time of procedure
Time frame: At time of ~1 hour scheduled procedure time (10 minute)
Pain Dilator Placement Using Visual Analog Scale
Title: Pain at time of dilator placement. Participants mark their associated pain score on a 10-cm visual analog scale at time of dilator placement with anchors of "no pain" at 0 cm and "worst pain in your life" at 10 cm. Higher scores indicate worse outcome.
Time frame: At time of 1 hour clinic visit (10 minutes)
Provider Assessment of Procedure as "Very Easy" or "Easy"
Survey providers blinded to study grouping regarding overall ease of procedure based on cervical dilation Identified procedures that were categorized as "Very Easy" or "Easy" (Survey response based on Likert scale: "Very Easy," "Easy," "Moderate," "Difficult," "Very Difficult")
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Time frame: At time of ~1 hour scheduled procedure time
Number of Participants That Experienced Complications
Composite of complications including cervical lacerations requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infections, additional surgical procedures, or extramural deliveries
Time frame: At time of ~1 hour scheduled procedure time (0-30 minute)
Number of Participants That Required Mechanical Dilation
Number of participants that required mechanical dilation at time of procedure
Time frame: At time of ~1 hour scheduled procedure time