NCT05097326: MiLI

Mifepristone for Labor Induction

Completed Phase 3 Results posted Last updated 31 July 2024

What this trial tests

Phase 3 trial testing Mifepristone in Induced Vaginal Delivery in 30 participants. Completed in 29 April 2023.

Timeline

27 June 2022

Primary endpoint
29 April 2023

29 April 2023

Quick facts

Lead sponsor	Stanford University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	27 June 2022
Primary completion	29 April 2023
Estimated completion	29 April 2023
Sites	1 location across United States

Drugs / interventions tested

• Mifepristone (MIFEPRISTONE) — full drug profile →
• Misoprostol (Misoprostol) — full drug profile →

Conditions studied

• Induced Vaginal Delivery — all drugs for Induced Vaginal Delivery →

Sponsor

Stanford University

Who can join

Adults 18 to 45, female only, with Induced Vaginal Delivery. 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 Uterine Contractions Primary · Up to approximately 72 hours, from start of labor induction to removal of transcervical balloon

Measured total number of uterine contractions per hour - with and without fetal heart rate decelerations.

Total

Group	Value	95% CI
Mifepristone	103	68 – 156
Misoprostol	112	84 – 186

Per hour

Group	Value	95% CI
Mifepristone	9	6 – 13
Misoprostol	15	9 – 17

Number of Participants With Uterine Tachysystole Primary · Up to approximately 72 hours from start of labor induction

Participants with uterine tachysystole (more than 5 contractions in 10 minutes with and without fetal heart rate decelerations) .

Uterine tachysystole-12 hours post administration

Group	Value	95% CI
Mifepristone	0
Misoprostol	5

Uterine tachysystole- total labor duration

Group	Value	95% CI
Mifepristone	1
Misoprostol	5

Number of Minutes in Hypertonus Primary · Up to approximately 72 hours, from start of labor induction until the time of delivery

Time in hypertonus (a single contraction lasting more than 2 minutes) per hour.

Group	Value	95% CI
Mifepristone	1.33	± 5.16
Misoprostol	0.93	± 2.49

Time to Complete Cervical Dilation Primary · Up to approximately 72 hours from start of labor induction

Total time from start of labor induction to complete cervical dilation (10 cm).

Group	Value	95% CI
Mifepristone	24.0	16.0 – 33.0
Misoprostol	16.0	11.0 – 22.0

Time to Delivery Primary · Up to approximately 72 hours, from start of labor induction until the time of delivery

Group	Value	95% CI
Mifepristone	26.0	12.0 – 39.0
Misoprostol	19.0	13.0 – 26.0

Total Labor and Delivery Unit Admission Duration Time Primary · Up to approximately 80 hours after the time of Labor and delivery admission

Total time on Labor \& Delivery from the time of admission to the time of transfer to postpartum unit

Group	Value	95% CI
Mifepristone	29.0	24.0 – 41.0
Misoprostol	21.0	15.0 – 32.0

Number of Patients Who Undergo Cesarean Delivery Primary · Up to approximately 72 hours from start of labor induction

Group	Value	95% CI
Mifepristone	5
Misoprostol	2

Number of Patients Able to Achieve Active Labor Primary · Up to approximately 72 hours from start of labor induction

Active labor defined as cervical of dilation \>=6 cm.

Group	Value	95% CI
Mifepristone	13
Misoprostol	13

Number of Patients With Severe Maternal Morbidity Primary · Up to approximately 1 week after hospital admission for delivery

Number of participants with serious maternal morbidity based on CDC criteria for major maternal morbidity and mortality

Group	Value	95% CI
Mifepristone	0
Misoprostol	1

Mean Neonatal Arterial Cord Blood pH Primary · Within approximately 2 hours after delivery (approximately 5 minutes to obtain sample)

Laboratory values for neonatal arterial cord blood pH. Arterial pH lower than 7.0 indicates metabolic acidosis.

Group	Value	95% CI
Mifepristone	7.16	± 0.06
Misoprostol	7.17	± 0.06

Number of Participants With Neonatal APGAR Score <7 Primary · At 1 minute and 5 minutes of infant life (approximately 10 seconds to perform each assessment)

Compare the APGAR scores (at 1 and 5 minutes). The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2; scores are summed for an overall score of 0 to 10 (higher scores reflect better neonatal outcomes).

1 minute

Group	Value	95% CI
Mifepristone	5
Misoprostol	1

5 minutes

Group	Value	95% CI
Mifepristone	1
Misoprostol	0

Number of Patients With Serious Neonatal Morbidity Primary · Up to 7 days after birth

Defined as need for respiratory support within 72 hours after birth, hypoxic-ischemic encephalopathy, seizure, infection, meconium aspiration syndrome, intracranial or subgaleal hemorrhage, hypotension requiring vasopressor support, admission to neonatal intensive care unit

Group	Value	95% CI
Mifepristone	3
Misoprostol	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Average approximately 2 to 3 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mifepristone

Serious: 3/15 (20%)

Deaths: 0/15

Misoprostol

Serious: 1/15 (7%)

Deaths: 0/15

Serious adverse events (2 terms)

Reaction	System	Mifepristone	Misoprostol
Unanticipated NICU admission	Pregnancy, puerperium and perinatal conditions	—	—
Hysterectomy, postpartum hemorrhage	Pregnancy, puerperium and perinatal conditions	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Mifepristone	Misoprostol
5 min APGAR <7	Pregnancy, puerperium and perinatal conditions	—	—

Most-reported serious reactions: Unanticipated NICU admission, Hysterectomy, postpartum hemorrhage.

Data from ClinicalTrials.gov NCT05097326 adverse events section.

Sponsor's own description

The purpose of this trial is to explore mifepristone as an option for induction of labor at term by evaluating the efficacy of mifepristone use for cervical preparation. Since the Labor Induction versus Expectant Management in Low-Risk Nulliparous Women (ARRIVE) trial supporting that elective induction after 39 weeks decreases cesarean sections and morbidity, rates of elective term inductions are increasing.

At Lucile Packard Children's Hospital at Stanford University specifically, approximately 40% of spontaneous vaginal deliveries follow induction of labor, with an average induction time of 20 hours. Previous studies have established the maternal and neonatal safety of mifepristone in term inductions, however, this study will assess the difference in overall time from induction to complete cervical dilation, delivery, and the total time on Labor and Delivery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.