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Sponsor declined to provide further funding/product support.
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| Name | Class |
|---|---|
| Ferring Pharmaceuticals | INDUSTRY |
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Induction of labor is a frequently planned obstetric procedure. Induction for women with an unfavorable cervix (bishop score <6) increases the risk of cesarean section. This risk may be reduced by ripening or softening the cervix before the induction of labor. This protocol outlines a randomized trial of 200 women evaluating the placement and use of Cervidil to the post vaginal fornix to soften the cervix in preparation for induction.
This trial is looking at inpatient vs outpatient pre-induction cervical ripening using Cervidil and the effects on (1) maternal and newborn outcomes including time of admission to delivery, (2) system healthcare cost, (3) cost to patient, and (4) patient satisfaction.
The investigators hypothesize when compared to patients admitted to the hospital for cervical ripening:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient Cervical Ripening | Experimental | Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction. |
|
| Inpatient Cervical Ripening | Active Comparator | The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Outpatient Dinoprostone 10mg | Drug | Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction. |
| Measure | Description | Time Frame |
|---|---|---|
| Dilation Completion Time | Time of admission for induction to complete dilation. | Time of admission to completion of dilation (up to 48 hours) |
| Total Cost of Induction Charged to Patient | Total hospital charges to patient, as obtained by Intermountain Healthcare billing | Through study completion (up to 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction: Survey | Measured by patient satisfaction/pain/anxiety survey. Questions about patient satifisfaction, pain, and anxiety will have Likert scale responses that range from 2 to 10 choices. Each question will be evaluated independently between cases and controls. | Time of delivery to discharge (up to 96 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Infant 5 Minute APGAR Score | APGAR score 5 minutes after delivery. The score ranges from 0 to 10 and a score of 7 or above is considered good health. | From delivery to 5 minutes following delivery |
| Time of Admission to Postpartum |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Nichols, DO | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dixie Regional Medical Center | St. George | Utah | 84790 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32852803 | Derived | Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Outpatient Cervical Ripening | Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction. Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction. |
| FG001 | Inpatient Cervical Ripening | The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol. Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Outpatient Cervical Ripening | Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction. Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Dilation Completion Time | Time of admission for induction to complete dilation. | Trial terminated prior to meeting sufficient sample size for analysis. | Posted | Time of admission to completion of dilation (up to 48 hours) |
|
Enrollment period - Approximately 5 months
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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 | Outpatient Cervical Ripening | Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction. Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Serious Adverse Event | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Post-surgical bleeding |
Trial terminated prior to meeting sufficient sample size for outcome analyses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Molly Adams, Clinical Research Project Coordinator | Intermountain Healthcare | (801)507-7030 | molly.adams@imail.org |
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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 | Dec 9, 2019 | Aug 11, 2021 | Prot_SAP_000.pdf |
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|
|
| Inpatient Dinoprostone 10 mg | Drug | Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized. |
|
|
| Vaginal Delivery Rate |
Number of patients enrolled who delivered vaginally |
| Through study completion (up to 1 year) |
| Operative Vaginal Delivery Rate | Number of patients enrolled who required an operative vaginal delivery | Through study completion (up to 1 year) |
| Cesarean Delivery Rate | Number of patients enrolled who had a c-section delivery | Through study completion (up to 1 year) |
| Start of Oxytocin Until Delivery | Length of time between patient receiving oxytocin and delivery | Time oxytocin is administered to time of delivery (up to 24 hours) |
| Time of Delivery Until Discharge | Length of time between delivery and discharge. | Time of delivery to discharge (up to 96 hours) |
| Time of Admission Until Discharge | Total length of time patient was hospitalized, from admission to Labor and Delivery until discharge | Time of admission to labor and delivery to discharge (up to 96 hours) |
Length of stay on postpartum unit.
| Time of admission to postpartum until discharge (up to 96 hours) |
| NICU Admission | Length of time spent in NICU | Time of admission to NICU to discharge (up to 3 weeks) |
| BG001 | Inpatient Cervical Ripening | The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol. Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Inpatient Cervical Ripening | The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol. Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized. |
|
| Primary | Total Cost of Induction Charged to Patient | Total hospital charges to patient, as obtained by Intermountain Healthcare billing | Trial terminated prior to meeting sample size for sufficient analysis. | Posted | Through study completion (up to 1 year) |
|
|
| Secondary | Patient Satisfaction: Survey | Measured by patient satisfaction/pain/anxiety survey. Questions about patient satifisfaction, pain, and anxiety will have Likert scale responses that range from 2 to 10 choices. Each question will be evaluated independently between cases and controls. | Trial terminated prior to meeting sufficient sample size for analysis. | Posted | Time of delivery to discharge (up to 96 hours) |
|
|
| Secondary | Vaginal Delivery Rate | Number of patients enrolled who delivered vaginally | Trial terminated prior to meeting sufficient sample size for analysis. | Posted | Through study completion (up to 1 year) |
|
|
| Secondary | Operative Vaginal Delivery Rate | Number of patients enrolled who required an operative vaginal delivery | Trial terminated prior to meeting sufficient sample size for analysis. | Posted | Through study completion (up to 1 year) |
|
|
| Secondary | Cesarean Delivery Rate | Number of patients enrolled who had a c-section delivery | Trial terminated prior to meeting sufficient sample size for analysis. | Posted | Through study completion (up to 1 year) |
|
|
| Secondary | Start of Oxytocin Until Delivery | Length of time between patient receiving oxytocin and delivery | Trial terminated prior to meeting sufficient sample size for analysis. | Posted | Time oxytocin is administered to time of delivery (up to 24 hours) |
|
|
| Secondary | Time of Delivery Until Discharge | Length of time between delivery and discharge. | Trial terminated prior to meeting sufficient sample size for analysis. | Posted | Time of delivery to discharge (up to 96 hours) |
|
|
| Secondary | Time of Admission Until Discharge | Total length of time patient was hospitalized, from admission to Labor and Delivery until discharge | Trial terminated prior to meeting sufficient sample size for analysis. | Posted | Time of admission to labor and delivery to discharge (up to 96 hours) |
|
|
| Other Pre-specified | Infant 5 Minute APGAR Score | APGAR score 5 minutes after delivery. The score ranges from 0 to 10 and a score of 7 or above is considered good health. | Trial terminated prior to meeting sufficient sample size for analysis. | Posted | From delivery to 5 minutes following delivery |
|
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| Other Pre-specified | Time of Admission to Postpartum | Length of stay on postpartum unit. | Trial terminated prior to meeting sufficient sample size for analysis. | Posted | Time of admission to postpartum until discharge (up to 96 hours) |
|
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| Other Pre-specified | NICU Admission | Length of time spent in NICU | Trial terminated prior to meeting sufficient sample size for analysis. | Posted | Time of admission to NICU to discharge (up to 3 weeks) |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Inpatient Cervical Ripening | The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol. Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized. | 0 | 4 | 0 | 4 | 1 | 4 |
|
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