Trial Outcomes & Findings for Cervical Preparation With Mifepristone Prior to Osmotic Dilators (NCT NCT03714880)

Last Updated: 2022-06-08

Results Overview

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."

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

At time of 1 hour clinic visit (10 minutes)

Results posted on

2022-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Mifepristone Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement Mifepristone 200 MG: Ingestion of study medication	Placebo Participants ingest placebo oral medication once 18-24 hours prior to dilator placement Placebo Oral Tablet: Ingestion of placebo
Overall Study STARTED	20	24
Overall Study COMPLETED	19	22
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cervical Preparation With Mifepristone Prior to Osmotic Dilators

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mifepristone n=19 Participants Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement Mifepristone 200 MG: Ingestion of study medication	Placebo n=22 Participants Participants ingest placebo oral medication once 18-24 hours prior to dilator placement Placebo Oral Tablet: Ingestion of placebo	Total n=41 Participants Total of all reporting groups
Age, Continuous	27 years n=5 Participants	27.5 years n=7 Participants	27 years n=5 Participants
Sex/Gender, Customized Assigned female sex	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
BMI	29.1 kg/m^2 n=5 Participants	27.9 kg/m^2 n=7 Participants	28.9 kg/m^2 n=5 Participants
Obstetrical history History of vaginal delivery	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Obstetrical history History of cesarean delivery only	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Obstetrical history Nulliparous	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Gestational age 18w0d-19w6d	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Gestational age 20w0d-21w6d	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Gestational age 22w0d-23w6d	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
History of cervical procedures	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Education - high school diploma or less	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Married, current	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: At time of 1 hour clinic visit (10 minutes)

Outcome measures

Outcome measures
Measure	Mifepristone n=19 Participants Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement Mifepristone 200 MG: Ingestion of study medication	Placebo n=22 Participants Participants ingest placebo oral medication once 18-24 hours prior to dilator placement Placebo Oral Tablet: Ingestion of placebo
Number of Participants That Had Placement of Expected Dilators or More	17 Participants	21 Participants

SECONDARY outcome

Timeframe: At time of ~1 hour scheduled procedure time (1 minute)

Measurement of cervical dilation at time of procedure

Outcome measures

Outcome measures
Measure	Mifepristone n=19 Participants Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement Mifepristone 200 MG: Ingestion of study medication	Placebo n=22 Participants Participants ingest placebo oral medication once 18-24 hours prior to dilator placement Placebo Oral Tablet: Ingestion of placebo
Cervical Dilation	3.2 cm Interval 2.6 to 3.6	2.6 cm Interval 2.1 to 3.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Mifepristone n=19 Participants Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement Mifepristone 200 MG: Ingestion of study medication	Placebo n=22 Participants Participants ingest placebo oral medication once 18-24 hours prior to dilator placement Placebo Oral Tablet: Ingestion of placebo
Number of Participants That Required Mechanical Dilation	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mifepristone n=19 Participants Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement Mifepristone 200 MG: Ingestion of study medication	Placebo n=22 Participants Participants ingest placebo oral medication once 18-24 hours prior to dilator placement Placebo Oral Tablet: Ingestion of placebo
Pain Dilator Placement Using Visual Analog Scale	1.2 cm Interval 0.0 to 6.6	3.3 cm Interval 0.6 to 6.1

SECONDARY outcome

Timeframe: 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")

Outcome measures

Outcome measures
Measure	Mifepristone n=19 Participants Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement Mifepristone 200 MG: Ingestion of study medication	Placebo n=22 Participants Participants ingest placebo oral medication once 18-24 hours prior to dilator placement Placebo Oral Tablet: Ingestion of placebo
Provider Assessment of Procedure as "Very Easy" or "Easy"	8 Participants	9 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Mifepristone n=19 Participants Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement Mifepristone 200 MG: Ingestion of study medication	Placebo n=22 Participants Participants ingest placebo oral medication once 18-24 hours prior to dilator placement Placebo Oral Tablet: Ingestion of placebo
Number of Participants That Experienced Complications	3 Participants	3 Participants

SECONDARY outcome

Timeframe: At time of ~1 hour scheduled procedure time

Number of participants that required mechanical dilation at time of procedure

Outcome measures

Outcome measures
Measure	Mifepristone n=19 Participants Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement Mifepristone 200 MG: Ingestion of study medication	Placebo n=22 Participants Participants ingest placebo oral medication once 18-24 hours prior to dilator placement Placebo Oral Tablet: Ingestion of placebo
Number of Participants That Required Mechanical Dilation	2 Participants	4 Participants

Adverse Events

Mifepristone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mifepristone n=19 participants at risk Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement Mifepristone 200 MG: Ingestion of study medication	Placebo n=22 participants at risk Participants ingest placebo oral medication once 18-24 hours prior to dilator placement Placebo Oral Tablet: Ingestion of placebo
Injury, poisoning and procedural complications Elective withdrawal of participant after study medication ingestion	0.00% 0/19 • 3 days	4.5% 1/22 • Number of events 1 • 3 days

Other adverse events

Adverse event data not reported

Additional Information

Suji Uhm, MD, MPH

University of Pittsburgh

Phone: 412-641-4590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place