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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mifepristone | Active Comparator | Participants will be given mifepristone with insertion of the cervical Cook balloon for labor induction |
|
| Misoprostol | Active Comparator | Participants will be given misoprostol with insertion of the cervical Cook balloon for labor induction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug | Mifepristone 200mg taken orally |
| |
| Misoprostol |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Uterine Contractions | Measured total number of uterine contractions per hour - with and without fetal heart rate decelerations. | 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) . | 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. | 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). | Up to approximately 72 hours from start of labor induction |
| Time to Delivery | 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 | Up to approximately 80 hours after the time of Labor and delivery admission |
| Number of Patients Who Undergo Cesarean Delivery | Up to approximately 72 hours from start of labor induction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital | Palo Alto | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mifepristone | Mifepristone 200 mg orally plus cervical Cook balloon |
| FG001 | Misoprostol | Misoprostol 50 mcg orally plus cervical Cook balloon |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mifepristone | Mifepristone 200 mg orally plus cervical Cook balloon |
| BG001 | Misoprostol | Misoprostol 50 mcg orally plus cervical Cook balloon |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Uterine Contractions | Measured total number of uterine contractions per hour - with and without fetal heart rate decelerations. | Intent to treat analysis set: all participants who were randomized regardless of what treatment (if any) they received. | Posted | Median | Inter-Quartile Range | contractions | Up to approximately 72 hours, from start of labor induction to removal of transcervical balloon |
|
Average approximately 2 to 3 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mifepristone | Mifepristone 200 mg orally plus cervical Cook balloon | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unanticipated NICU admission | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 5 min APGAR <7 | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Not related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Stanford University | (650) 497-5175 | gynresearch@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2022 | Mar 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Drug |
Misoprostol 50 mcg taken orally, and may receive additional doses of misoprostol 50 - 100 mcg as needed |
|
| Number of Patients Able to Achieve Active Labor | Active labor defined as cervical of dilation >=6 cm. | 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 | 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. | 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). | 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 | Up to 7 days after birth |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Number of Participants With Uterine Tachysystole | Participants with uterine tachysystole (more than 5 contractions in 10 minutes with and without fetal heart rate decelerations) . | Intent to treat analysis set | Posted | Count of Participants | Participants | Up to approximately 72 hours from start of labor induction |
|
|
|
|
| Primary | Number of Minutes in Hypertonus | Time in hypertonus (a single contraction lasting more than 2 minutes) per hour. | Intent to treat analysis set | Posted | Mean | Standard Deviation | minutes | Up to approximately 72 hours, from start of labor induction until the time of delivery |
|
|
|
|
| Primary | Time to Complete Cervical Dilation | Total time from start of labor induction to complete cervical dilation (10 cm). | Intent to treat analysis set | Posted | Median | Inter-Quartile Range | hours | Up to approximately 72 hours from start of labor induction |
|
|
|
|
| Primary | Time to Delivery | Intent to treat analysis set | Posted | Median | Inter-Quartile Range | hours | Up to approximately 72 hours, from start of labor induction until the time of delivery |
|
|
|
|
| Primary | 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 | Intent to treat analysis set | Posted | Median | Inter-Quartile Range | hours | Up to approximately 80 hours after the time of Labor and delivery admission |
|
|
|
|
| Primary | Number of Patients Who Undergo Cesarean Delivery | Intent to treat analysis set | Posted | Count of Participants | Participants | Up to approximately 72 hours from start of labor induction |
|
|
|
|
| Primary | Number of Patients Able to Achieve Active Labor | Active labor defined as cervical of dilation >=6 cm. | Intent to treat analysis set. | Posted | Count of Participants | Participants | Up to approximately 72 hours from start of labor induction |
|
|
|
|
| Primary | Number of Patients With Severe Maternal Morbidity | Number of participants with serious maternal morbidity based on CDC criteria for major maternal morbidity and mortality | Intent to treat analysis set | Posted | Count of Participants | Participants | Up to approximately 1 week after hospital admission for delivery |
|
|
|
|
| Primary | Mean Neonatal Arterial Cord Blood pH | Laboratory values for neonatal arterial cord blood pH. Arterial pH lower than 7.0 indicates metabolic acidosis. | Neonatal cords available for analysis | Posted | Mean | Standard Deviation | pH | Within approximately 2 hours after delivery (approximately 5 minutes to obtain sample) | Neonatal cords | Neonatal cords |
|
|
|
|
| Primary | 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). | Neonates are included in the analysis but were not considered enrolled in the study. | Posted | Count of Units | Neonates | At 1 minute and 5 minutes of infant life (approximately 10 seconds to perform each assessment) | Neonates | Neonates |
|
|
|
|
| Primary | 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 | Neonates are included in the analysis but were not considered enrolled in the study. | Posted | Count of Units | Neonates | Up to 7 days after birth | Neonates | Neonates |
|
|
|
|
| 15 |
| 3 |
| 15 |
| 1 |
| 15 |
| EG001 | Misoprostol | Misoprostol 50 mcg orally plus cervical Cook balloon | 0 | 15 | 1 | 15 | 0 | 15 |
| Hysterectomy, postpartum hemorrhage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
|
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| D011083 |
| Polycyclic Compounds |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| Fisher Exact |
| 0.17 |
a p-value of <0.05 would be considered statistically significant |
| Other |
| 1 |
A p-value of <0.05 would be statistically significant. |
| Other |