Trial Outcomes & Findings for Mifepristone for Labor Induction (NCT NCT05097326)

NCT ID: NCT05097326

Last Updated: 2024-07-31

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 30 participants
• Primary outcome timeframe: Up to approximately 72 hours, from start of labor induction to removal of transcervical balloon
• Results posted on: 2024-07-31

Participant Flow

Participant milestones

Measure	Mifepristone Mifepristone 200 mg orally plus cervical Cook balloon	Misoprostol Misoprostol 50 mcg orally plus cervical Cook balloon
Overall Study STARTED	15	15
Overall Study Received Medication	14	15
Overall Study COMPLETED	14	15
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Mifepristone Mifepristone 200 mg orally plus cervical Cook balloon	Misoprostol Misoprostol 50 mcg orally plus cervical Cook balloon
Overall Study Spontaneous labor prior to medication administration	1	0

Baseline Characteristics

Mifepristone for Labor Induction

Baseline characteristics by cohort

Measure	Mifepristone n=15 Participants Mifepristone 200 mg orally plus cervical Cook balloon	Misoprostol n=15 Participants Misoprostol 50 mcg orally plus cervical Cook balloon	Total n=30 Participants Total of all reporting groups
Age, Continuous	30.46 years STANDARD_DEVIATION 4.64 • n=5 Participants	31.21 years STANDARD_DEVIATION 7.07 • n=7 Participants	30.82 years STANDARD_DEVIATION 5.84 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Other	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 72 hours, from start of labor induction to removal of transcervical balloon

Population: Intent to treat analysis set: all participants who were randomized regardless of what treatment (if any) they received.

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

Outcome measures

Measure	Mifepristone n=15 Participants Mifepristone 200 mg orally plus cervical Cook balloon	Misoprostol n=15 Participants Misoprostol 50 mcg orally plus cervical Cook balloon
Number of Uterine Contractions Total	103 contractions Interval 68.0 to 156.0	112 contractions Interval 84.0 to 186.0
Number of Uterine Contractions Per hour	9 contractions Interval 6.0 to 13.0	15 contractions Interval 9.0 to 17.0

PRIMARY outcome

Timeframe: Up to approximately 72 hours from start of labor induction

Population: Intent to treat analysis set

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

Outcome measures

Measure	Mifepristone n=15 Participants Mifepristone 200 mg orally plus cervical Cook balloon	Misoprostol n=15 Participants Misoprostol 50 mcg orally plus cervical Cook balloon
Number of Participants With Uterine Tachysystole Uterine tachysystole-12 hours post administration	0 Participants	5 Participants
Number of Participants With Uterine Tachysystole Uterine tachysystole- total labor duration	1 Participants	5 Participants

PRIMARY outcome

Timeframe: Up to approximately 72 hours, from start of labor induction until the time of delivery

Population: Intent to treat analysis set

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

Outcome measures

Measure	Mifepristone n=15 Participants Mifepristone 200 mg orally plus cervical Cook balloon	Misoprostol n=15 Participants Misoprostol 50 mcg orally plus cervical Cook balloon
Number of Minutes in Hypertonus	1.33 minutes Standard Deviation 5.16	0.93 minutes Standard Deviation 2.49

PRIMARY outcome

Timeframe: Up to approximately 72 hours from start of labor induction

Population: Intent to treat analysis set

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

Outcome measures

Measure	Mifepristone n=15 Participants Mifepristone 200 mg orally plus cervical Cook balloon	Misoprostol n=15 Participants Misoprostol 50 mcg orally plus cervical Cook balloon
Time to Complete Cervical Dilation	24.0 hours Interval 16.0 to 33.0	16.0 hours Interval 11.0 to 22.0

PRIMARY outcome

Timeframe: Up to approximately 72 hours, from start of labor induction until the time of delivery

Population: Intent to treat analysis set

Outcome measures

Measure	Mifepristone n=15 Participants Mifepristone 200 mg orally plus cervical Cook balloon	Misoprostol n=15 Participants Misoprostol 50 mcg orally plus cervical Cook balloon
Time to Delivery	26.0 hours Interval 12.0 to 39.0	19.0 hours Interval 13.0 to 26.0

PRIMARY outcome

Timeframe: Up to approximately 80 hours after the time of Labor and delivery admission

Population: Intent to treat analysis set

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

Outcome measures

Measure	Mifepristone n=15 Participants Mifepristone 200 mg orally plus cervical Cook balloon	Misoprostol n=15 Participants Misoprostol 50 mcg orally plus cervical Cook balloon
Total Labor and Delivery Unit Admission Duration Time	29.0 hours Interval 24.0 to 41.0	21.0 hours Interval 15.0 to 32.0

PRIMARY outcome

Timeframe: Up to approximately 72 hours from start of labor induction

Population: Intent to treat analysis set

Outcome measures

Measure	Mifepristone n=15 Participants Mifepristone 200 mg orally plus cervical Cook balloon	Misoprostol n=15 Participants Misoprostol 50 mcg orally plus cervical Cook balloon
Number of Patients Who Undergo Cesarean Delivery	5 Participants	2 Participants

PRIMARY outcome

Timeframe: Up to approximately 72 hours from start of labor induction

Population: Intent to treat analysis set.

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

Outcome measures

Measure	Mifepristone n=15 Participants Mifepristone 200 mg orally plus cervical Cook balloon	Misoprostol n=15 Participants Misoprostol 50 mcg orally plus cervical Cook balloon
Number of Patients Able to Achieve Active Labor	13 Participants	13 Participants

PRIMARY outcome

Timeframe: Up to approximately 1 week after hospital admission for delivery

Population: Intent to treat analysis set

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

Outcome measures

Measure	Mifepristone n=15 Participants Mifepristone 200 mg orally plus cervical Cook balloon	Misoprostol n=15 Participants Misoprostol 50 mcg orally plus cervical Cook balloon
Number of Patients With Severe Maternal Morbidity	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Within approximately 2 hours after delivery (approximately 5 minutes to obtain sample)

Population: Neonatal cords available for analysis

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

Outcome measures

Measure	Mifepristone n=12 Neonatal cords Mifepristone 200 mg orally plus cervical Cook balloon	Misoprostol n=11 Neonatal cords Misoprostol 50 mcg orally plus cervical Cook balloon
Mean Neonatal Arterial Cord Blood pH	7.16 pH Standard Deviation 0.06	7.17 pH Standard Deviation 0.06

PRIMARY outcome

Timeframe: At 1 minute and 5 minutes of infant life (approximately 10 seconds to perform each assessment)

Population: Neonates are included in the analysis but were not considered enrolled in the study.

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).

Outcome measures

Measure	Mifepristone n=15 Neonates Mifepristone 200 mg orally plus cervical Cook balloon	Misoprostol n=15 Neonates Misoprostol 50 mcg orally plus cervical Cook balloon
Number of Participants With Neonatal APGAR Score <7 1 minute	5 Neonates	1 Neonates
Number of Participants With Neonatal APGAR Score <7 5 minutes	1 Neonates	0 Neonates

PRIMARY outcome

Timeframe: Up to 7 days after birth

Population: Neonates are included in the analysis but were not considered enrolled in the study.

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

Outcome measures

Measure	Mifepristone n=15 Neonates Mifepristone 200 mg orally plus cervical Cook balloon	Misoprostol n=15 Neonates Misoprostol 50 mcg orally plus cervical Cook balloon
Number of Patients With Serious Neonatal Morbidity	3 Neonates	0 Neonates

Adverse Events

Mifepristone

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Misoprostol

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mifepristone n=15 participants at risk Mifepristone 200 mg orally plus cervical Cook balloon	Misoprostol n=15 participants at risk Misoprostol 50 mcg orally plus cervical Cook balloon
Pregnancy, puerperium and perinatal conditions Unanticipated NICU admission	6.7% 1/15 • Average approximately 2 to 3 days.	0.00% 0/15 • Average approximately 2 to 3 days.
Pregnancy, puerperium and perinatal conditions Hysterectomy, postpartum hemorrhage	0.00% 0/15 • Average approximately 2 to 3 days.	6.7% 1/15 • Average approximately 2 to 3 days.

Other adverse events

Measure	Mifepristone n=15 participants at risk Mifepristone 200 mg orally plus cervical Cook balloon	Misoprostol n=15 participants at risk Misoprostol 50 mcg orally plus cervical Cook balloon
Pregnancy, puerperium and perinatal conditions 5 min APGAR <7	6.7% 1/15 • Average approximately 2 to 3 days.	0.00% 0/15 • Average approximately 2 to 3 days.

Additional Information

Principal Investigator

Stanford University

Phone: (650) 497-5175

Email: gynresearch@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place