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The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) for the induction of labor in term and near-term patients with premature rupture of membranes (PROM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRB plus Pitocin | Experimental |
| |
| Pitocin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRB | Device | Labor induction using the CRB |
| |
| Pitocin |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Labor | Time, in minutes, from the start of labor induction through delivery | Start of labor induction through delivery, an expected average of 6 hours |
| Incidence of Infection | number of patients with chorioamnionitis | Through hospital discharge, an expected average of 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugh Miller, MD | Watching Over Mothers and Babies (WOMB) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Medical Center (TMC) | Tucson | Arizona | 85712 | United States | ||
| University of South Florida |
Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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| ID | Title | Description |
|---|---|---|
| FG000 | CRB Plus Pitocin | CRB: Labor induction using the CRB Pitocin: Labor induction using Pitocin |
| FG001 | Pitocin | Pitocin: Labor induction using Pitocin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CRB Plus Pitocin | CRB: Labor induction using the CRB Pitocin: Labor induction using Pitocin |
| BG001 | Pitocin | Pitocin: Labor induction using Pitocin |
| 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 | Time of Labor | Time, in minutes, from the start of labor induction through delivery | Posted | Mean | Standard Deviation | Minutes | Start of labor induction through delivery, an expected average of 6 hours |
|
|
0-30 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 | CRB Plus Pitocin | CRB: Labor induction using the CRB Pitocin: Labor induction using Pitocin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Jaundice Neonatal | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrested Labor | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Saunders,MS, RAC; Manager, Biostatistics | Cook Research Incorporated | 765-463-7537 | 321204 | Alan.Saunders@CookMedical.com |
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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 | Apr 27, 2018 | Mar 12, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005322 | Fetal Membranes, Premature Rupture |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Drug |
Labor induction using Pitocin |
|
| Tampa |
| Florida |
| 33606 |
| United States |
| Kosair Children's Hospital Maternal Fetal Medicine Specialists | Louisville | Kentucky | 40202 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Multiple (2 or more) previous pregnancies | Count of Participants | Participants |
|
| Bishop score at time of enrollment | A scoring system used to assist in predicting whether induction of labor will be required. The total score is calculated by assessing the following five components on manual vaginal examination: cervical dilation, effacement, consistency, position, and fetal station. Each component is given a score of 0 to 3. The lowest possible total score would be 0 and the highest total score would be 13. The higher the total score (8 or above) the more likely a vaginal birth. The lower the score (6 or less) the more likely that intervention with a cervical ripening method may be needed to induce labor. | Two Patients (one in each arm) did not have their Bishop Score recorded. | Mean | Standard Deviation | units on a scale |
|
| Gestational age (weeks/days) | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Incidence of Infection | number of patients with chorioamnionitis | Posted | Count of Participants | Participants | Through hospital discharge, an expected average of 3 days |
|
|
|
|
| 0 |
| 63 |
| 5 |
| 63 |
| 27 |
| 63 |
| EG001 | Pitocin | Pitocin: Labor induction using Pitocin | 0 | 61 | 4 | 61 | 21 | 61 |
|
| Neonatal Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Hospitalization |
|
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Hospitalization |
|
| Infantile Apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Life Threatening |
|
| Postpartum hemorrhage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | 1 Life Threatening, 1 Hospitalization |
|
| Arrested Labor | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Hospitalization |
|
| Umbilical Cord Prolapse | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Congenital Abnormality or birth defect |
|
| Amniotic Cavity Infection | Infections and infestations | Systematic Assessment |
|
| Jaundice Neonatal | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
The sponsor can review results communications from PI prior to public release and can embargo communications of trial results between 60 and 180 days from the time submitted to the sponsor for review. The sponsor can embargo publications until the sponsor has published results or 180 days has elapsed after study closure at all participating sites. The sponsor cannot restrict publication but can require changes to protect sponsor's intellectual property rights or other confidential information.
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |