NCT03714880

Cervical Preparation With Mifepristone Prior to Osmotic Dilators

Terminated Phase 2 Results posted Last updated 8 June 2022

What this trial tests

Phase 2 trial testing Mifepristone 200 MG in Second Trimester Abortion in 44 participants. Terminated before completion.

Timeline

26 April 2019

Primary endpoint
26 February 2021

26 February 2021

Quick facts

Lead sponsor	University of California, Davis
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	44
Start date	26 April 2019
Primary completion	26 February 2021
Estimated completion	26 February 2021
Sites	1 location across United States

Drugs / interventions tested

• Mifepristone 200 MG — full drug profile →
• Placebo Oral Tablet — full drug profile →

Conditions studied

• Second Trimester Abortion — all drugs for Second Trimester Abortion →

Sponsor

University of California, Davis

Who can join

Adults 18 to 45, female only, with Second Trimester Abortion. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants That Had Placement of Expected Dilators or More Primary · 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, parti

Group	Value	95% CI
Mifepristone	17
Placebo	21

Cervical Dilation Secondary · At time of ~1 hour scheduled procedure time (1 minute)

Measurement of cervical dilation at time of procedure

Group	Value	95% CI
Mifepristone	3.2	2.6 – 3.6
Placebo	2.6	2.1 – 3.0

Number of Participants That Required Mechanical Dilation Secondary · 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

Group	Value	95% CI
Mifepristone	2
Placebo	4

Pain Dilator Placement Using Visual Analog Scale Secondary · 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.

Group	Value	95% CI
Mifepristone	1.2	0 – 6.6
Placebo	3.3	0.6 – 6.1

Provider Assessment of Procedure as "Very Easy" or "Easy" Secondary · 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")

Group	Value	95% CI
Mifepristone	8
Placebo	9

Number of Participants That Experienced Complications Secondary · 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

Group	Value	95% CI
Mifepristone	3
Placebo	3

Number of Participants That Required Mechanical Dilation Secondary · At time of ~1 hour scheduled procedure time

Number of participants that required mechanical dilation at time of procedure

Group	Value	95% CI
Mifepristone	2
Placebo	4

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mifepristone

Serious: 0/19 (0%)

Deaths: 0/19

Placebo

Serious: 1/22 (5%)

Deaths: 0/22

Serious adverse events (1 terms)

Reaction	System	Mifepristone	Placebo
Elective withdrawal of participant after study medication ingestion	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Elective withdrawal of participant after study medication ingestion.

Data from ClinicalTrials.gov NCT03714880 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cervical preparation for dilation and evacuation at 12 to 24 weeks gestation.
   Tufa TH, Stewart F, Meckstroth K, Diedrich JT, et al · · 2025 · PMID 40028776 · DOI 10.1002/14651858.cd007310.pub3