Induced Vaginal DeliveryPhase 3MiLINCT05097326

Mifepristone for Labor Induction

A Phase 3 study testing Mifepristone and Misoprostol in people with Induced Vaginal Delivery, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Induced Vaginal Delivery
What is being tested?: Mifepristone and Misoprostol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 27 Jun 2022to 29 Apr 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

Pregnant patients between ages 18 to 45 years
Singleton, live gestation
Nulliparous
Gestational age between 37 weeks 0 days - 42 weeks 0 days
Fetus in cephalic presentation
Patients admitted for labor induction

Show all 11Show fewer

Patients who are not in labor with intact membranes
Patients with no contraindication for vaginal delivery (placenta previa, vasa previa, active genital herpes)
Patients with no contraindications for mifepristone (chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, or other prostaglandins, hemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyria, or an intrauterine device (IUD) in place)
Patients with a Bishop score <6 at time of randomization
Transcervical balloon in place <3 hours prior to the time of randomization without prior cervical preparation

Who cannot join

Significant cardiac, renal, or hepatic maternal comorbidities, severe gestational hypertension or preeclampsia with severe features
Pregnancies complicated by major fetal anomalies
Patients with a uterine scar
Pregnancies complicated by fetal growth restriction (Estimated fetal weight <10%)
Pregnancies complicated by oligohydramnios
Fetuses with an estimated fetal weight >4500 gm by recent ultrasound or Leopold's exam on admission

Show all 13Show fewer

Patients with class 3 obesity (BMI >40)
Fetuses with a persistent category 2 or 3 fetal heart tracing at labor induction admission
Vaginal bleeding at the time of randomization
Any indication for scheduled cesarean delivery
Hypersensitivity to oxytocin
Uterine contractions equal to or greater than 5 in 10 minutes for sustained 30 minutes
Hypersensitivity to prostaglandins

Trial locations and contacts

1 site in 1 country.

United States1 site

Lucile Packard Children's Hospital
Palo Alto, California, 94304

Other trials in United States

About this study

Official title: Mifepristone as an Adjunct to Transcervical Balloon for Labor Induction (MiLI): A Randomized Clinical Trial

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.

Conditions: Induced Vaginal Delivery
Being tested: Mifepristone, Misoprostol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MifepristoneDrug
Mifepristone 200mg taken orally
MisoprostolDrug
Misoprostol 50 mcg taken orally, and may receive additional doses of misoprostol 50 - 100 mcg as needed

Study groups in NCT05097326
Study group	Role	What they receive
Mifepristone	Active comparator	Participants will be given mifepristone with insertion of the cervical Cook balloon for labor induction Receives: Drug: Mifepristone
Misoprostol	Active comparator	Participants will be given misoprostol with insertion of the cervical Cook balloon for labor induction Receives: Drug: Misoprostol

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Uterine Contractions
Measured total number of uterine contractions per hour - with and without fetal heart rate decelerations.
Measured: Up to approximately 72 hours, from start of labor induction to removal of transcervical balloon
Number of Participants With Uterine Tachysystole
Participants with uterine tachysystole (more than 5 contractions in 10 minutes with and without fetal heart rate decelerations) .
Measured: Up to approximately 72 hours from start of labor induction
Number of Minutes in Hypertonus
Time in hypertonus (a single contraction lasting more than 2 minutes) per hour.
Measured: Up to approximately 72 hours, from start of labor induction until the time of delivery
Time to Complete Cervical Dilation
Total time from start of labor induction to complete cervical dilation (10 cm).
Measured: Up to approximately 72 hours from start of labor induction
Time to Delivery
Measured: Up to approximately 72 hours, from start of labor induction until the time of delivery
Total Labor and Delivery Unit Admission Duration Time
Total time on Labor \& Delivery from the time of admission to the time of transfer to postpartum unit
Measured: Up to approximately 80 hours after the time of Labor and delivery admission
Number of Patients Who Undergo Cesarean Delivery
Measured: Up to approximately 72 hours from start of labor induction
Number of Patients Able to Achieve Active Labor
Active labor defined as cervical of dilation >=6 cm.
Measured: Up to approximately 72 hours from start of labor induction
Number of Patients With Severe Maternal Morbidity
Number of participants with serious maternal morbidity based on CDC criteria for major maternal morbidity and mortality
Measured: Up to approximately 1 week after hospital admission for delivery
Mean Neonatal Arterial Cord Blood pH
Laboratory values for neonatal arterial cord blood pH. Arterial pH lower than 7.0 indicates metabolic acidosis.
Measured: Within approximately 2 hours after delivery (approximately 5 minutes to obtain sample)
Number of Participants With Neonatal APGAR Score <7
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).
Measured: At 1 minute and 5 minutes of infant life (approximately 10 seconds to perform each assessment)
Number of Patients With Serious Neonatal Morbidity
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
Measured: Up to 7 days after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jun 202229 Apr 2023

First posted28 Oct 2021
Study start27 Jun 2022
Primary completion29 Apr 2023
Study completion29 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Induced Vaginal DeliveryStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05097326
Sponsor's protocol ID: 62448
Acronym: MiLI
Status last verified: Jul 2024
First submitted: 15 Oct 2021
Last updated: 31 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy
Induced; Birth
Recruiting
Ripening Approaches for Prompt Induction and Delivery - Sequential Versus Concurrent Dilapan-S and Misoprostol to Achieve Vaginal Delivery (RAPID-DS)
Nulliparous Women Who Scheduled for Labor Induction, Pregnancy
Not yet recruiting
RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
Perineal Trauma, Postpartum Pain
Active, not recruiting
Comparison of Vaginal PGE2 (Dinoprostone) and Vaginal Misoprostol for Induction of Labour in Primigravid Term Pregnancy
Labor, Induced, Term Pregnancy
Recruiting
PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM)
Premature Rupture of Fetal Membranes, Labor, Induced

All Induced Vaginal Delivery trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mifepristone as an Adjunct to Transcervical Balloon for Labor Induction (MiLI): A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT05097326
Acronym / sponsor ID: MiLI / 62448
Conditions: Induced Vaginal Delivery
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 27 Jun 2022 (actual)
Primary completion: 29 Apr 2023 (actual)
Study completion: 29 Apr 2023 (actual)
First posted: 28 Oct 2021 (actual)
Results: Posted 31 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mifepristone	Active comparator	Drug: MifepristoneParticipants will be given mifepristone with insertion of the cervical Cook balloon for labor induction
Misoprostol	Active comparator	Drug: MisoprostolParticipants will be given misoprostol with insertion of the cervical Cook balloon for labor induction

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Pregnant patients between ages 18 to 45 years
Singleton, live gestation
Nulliparous
Gestational age between 37 weeks 0 days - 42 weeks 0 days
Fetus in cephalic presentation

Key exclusion criteria (13 listed)

Significant cardiac, renal, or hepatic maternal comorbidities, severe gestational hypertension or preeclampsia with severe features
Pregnancies complicated by major fetal anomalies
Patients with a uterine scar
Pregnancies complicated by fetal growth restriction (Estimated fetal weight <10%)
Pregnancies complicated by oligohydramnios

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MifepristoneMifepristone 200mg taken orally	Drug	Mifepristone
MisoprostolMisoprostol 50 mcg taken orally, and may receive additional doses of misoprostol 50 - 100 mcg as needed	Drug	Misoprostol

Primary outcome

Number of Uterine Contractions
Time frame: 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.
Number of Participants With Uterine Tachysystole
Time frame: 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) .
Number of Minutes in Hypertonus
Time frame: 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.
Time to Complete Cervical Dilation
Time frame: Up to approximately 72 hours from start of labor induction
Total time from start of labor induction to complete cervical dilation (10 cm).
Time to Delivery
Time frame: Up to approximately 72 hours, from start of labor induction until the time of delivery
Total Labor and Delivery Unit Admission Duration Time
Time frame: 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
Number of Patients Who Undergo Cesarean Delivery
Time frame: Up to approximately 72 hours from start of labor induction
Number of Patients Able to Achieve Active Labor
Time frame: Up to approximately 72 hours from start of labor induction
Active labor defined as cervical of dilation >=6 cm.
Number of Patients With Severe Maternal Morbidity
Time frame: 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
Mean Neonatal Arterial Cord Blood pH
Time frame: 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.
Number of Participants With Neonatal APGAR Score <7
Time frame: 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).
Number of Patients With Serious Neonatal Morbidity
Time frame: 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

Results and safety

Results posted to the registry on 31 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mifepristone	15	14
Misoprostol	15	15

Primary outcome: Number of Uterine Contractions

Time frame: Up to approximately 72 hours, from start of labor induction to removal of transcervical balloon. Median (Inter-Quartile Range). Unit: contractions

Measure	Mifepristone n = 15	Misoprostol n = 15
Total	103 (68 to 156)	112 (84 to 186)
Per hour	9 (6 to 13)	15 (9 to 17)

Mifepristone vs Misoprostol: p = 0.44, Fisher Exact
Mifepristone vs Misoprostol: p = 0.02, Fisher Exact

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

Primary outcome: Number of Participants With Uterine Tachysystole

Time frame: Up to approximately 72 hours from start of labor induction. Count of participants. Unit: Participants

Measure	Mifepristone n = 15	Misoprostol n = 15
Uterine tachysystole-12 hours post administration	0	5
Uterine tachysystole- total labor duration	1	5

Mifepristone vs Misoprostol: p = 0.04, Fisher Exact
Mifepristone vs Misoprostol: p = 0.17, Fisher Exact

Population analysed: Intent to treat analysis set

Primary outcome: Number of Minutes in Hypertonus

Time frame: Up to approximately 72 hours, from start of labor induction until the time of delivery. Mean (Standard Deviation). Unit: minutes

Measure	Mifepristone n = 15	Misoprostol n = 15
Value	1.33 (5.16)	0.93 (2.49)

Mifepristone vs Misoprostol: p = 0.63, Wilcoxon (Mann-Whitney)

Population analysed: Intent to treat analysis set

Primary outcome: Time to Complete Cervical Dilation

Time frame: Up to approximately 72 hours from start of labor induction. Median (Inter-Quartile Range). Unit: hours

Measure	Mifepristone n = 15	Misoprostol n = 15
Value	24.0 (16.0 to 33.0)	16.0 (11.0 to 22.0)

Mifepristone vs Misoprostol: p = 0.01, Wilcoxon (Mann-Whitney)

Population analysed: Intent to treat analysis set

Adverse events

Time frame: Average approximately 2 to 3 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mifepristone	3 of 15 (20%)	1 of 15 (6.7%)	0 of 15
Misoprostol	1 of 15 (6.7%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Induced Vaginal Delivery

Not yet recruiting
Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy
Induced; Birth
Recruiting
Ripening Approaches for Prompt Induction and Delivery - Sequential Versus Concurrent Dilapan-S and Misoprostol to Achieve Vaginal Delivery (RAPID-DS)
Nulliparous Women Who Scheduled for Labor Induction, Pregnancy
Not yet recruiting
RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
Perineal Trauma, Postpartum Pain
Active, not recruiting
Comparison of Vaginal PGE2 (Dinoprostone) and Vaginal Misoprostol for Induction of Labour in Primigravid Term Pregnancy
Labor, Induced, Term Pregnancy
Recruiting
PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM)
Premature Rupture of Fetal Membranes, Labor, Induced

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mifepristone and Misoprostol in people with Induced Vaginal Delivery, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Uterine Contractions (time frame: Up to approximately 72 hours, from start of labor induction to removal of transcervical balloon). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05097326.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.