Second Trimester Abortion
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Ingestion of study medication vs placebo
DRUGPlacebo Oral Tablet
Ingestion of study medication vs placebo
Sponsors
Society of Family Planning
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
A. Age ≥18 years B. Gestational age to be 18 weeks 0 days through 23 weeks 6 days on procedure date C. Signed informed procedure consent for dilation and evacuation D. Willing to sign informed consent and follow study protocol
Exclusion criteria
A. Allergy or known intolerance to mifepristone B. Known contraindication to mifepristone for cervical preparation prior to dilation and evacuation: 1. Chronic adrenal failure or insufficiency 2. Concurrent use of long-term corticosteroid therapy 3. Inherited porphyrias C. Any condition that in the opinion of the investigator could impede study participation or collection of study data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Had Placement of Expected Dilators or More | At time of 1 hour clinic visit (10 minutes) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cervical Dilation | At time of ~1 hour scheduled procedure time (1 minute) | Measurement of cervical dilation at time of procedure |
| Number of Participants That Required Mechanical Dilation | At time of ~1 hour scheduled procedure time (10 minute) | A count of the number of participants that required of mechanical dilation at time of procedure |
| Pain Dilator Placement Using Visual Analog Scale | At time of 1 hour clinic visit (10 minutes) | 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. |
| Provider Assessment of Procedure as Very Easy or Easy | At time of ~1 hour scheduled procedure time | 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) |
| Number of Participants That Experienced Complications | At time of ~1 hour scheduled procedure time (0-30 minute) | Composite of complications including cervical lacerations requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infections, additional surgical procedures, or extramural deliveries |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mifepristone Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement
Mifepristone 200 MG: Ingestion of study medication | 19 |
| Placebo Participants ingest placebo oral medication once 18-24 hours prior to dilator placement
Placebo Oral Tablet: Ingestion of placebo | 22 |
| Total | 41 |
Baseline characteristics
| Characteristic | Mifepristone | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 27 years | 27.5 years | 27 years |
| BMI | 29.1 kg/m^2 | 27.9 kg/m^2 | 28.9 kg/m^2 |
| Education - high school diploma or less | 9 Participants | 10 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 17 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gestational age 18w0d-19w6d | 1 Participants | 5 Participants | 6 Participants |
| Gestational age 20w0d-21w6d | 11 Participants | 9 Participants | 20 Participants |
| Gestational age 22w0d-23w6d | 7 Participants | 8 Participants | 15 Participants |
| History of cervical procedures | 1 Participants | 1 Participants | 2 Participants |
| Married, current | 2 Participants | 3 Participants | 5 Participants |
| Obstetrical history History of cesarean delivery only | 3 Participants | 4 Participants | 7 Participants |
| Obstetrical history History of vaginal delivery | 11 Participants | 11 Participants | 22 Participants |
| Obstetrical history Nulliparous | 5 Participants | 7 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 7 Participants | 11 Participants | 18 Participants |
| Sex/Gender, Customized Assigned female sex | 19 Participants | 22 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 22 |
| other Total, other adverse events | 0 / 19 | 0 / 22 |
| serious Total, serious adverse events | 0 / 19 | 1 / 22 |
Outcome results
Primary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mifepristone | Number of Participants That Had Placement of Expected Dilators or More | 17 Participants |
| Placebo | Number of Participants That Had Placement of Expected Dilators or More | 21 Participants |
Secondary
Cervical Dilation
Measurement of cervical dilation at time of procedure
Time frame: At time of ~1 hour scheduled procedure time (1 minute)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mifepristone | Cervical Dilation | 3.2 cm |
| Placebo | Cervical Dilation | 2.6 cm |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mifepristone | Number of Participants That Experienced Complications | 3 Participants |
| Placebo | Number of Participants That Experienced Complications | 3 Participants |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mifepristone | Number of Participants That Required Mechanical Dilation | 2 Participants |
| Placebo | Number of Participants That Required Mechanical Dilation | 4 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mifepristone | Number of Participants That Required Mechanical Dilation | 2 Participants |
| Placebo | Number of Participants That Required Mechanical Dilation | 4 Participants |
Secondary
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mifepristone | Pain Dilator Placement Using Visual Analog Scale | 1.2 cm |
| Placebo | Pain Dilator Placement Using Visual Analog Scale | 3.3 cm |
Secondary
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)
Time frame: At time of ~1 hour scheduled procedure time
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mifepristone | Provider Assessment of Procedure as Very Easy or Easy | 8 Participants |
| Placebo | Provider Assessment of Procedure as Very Easy or Easy | 9 Participants |