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Gathering information from the PI records to provide this response.
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In women undergoing labor induction for membrane rupture at or near term, we are investigating the addition of a foley catheter placed in the cervix to standard therapy (oxytocin administration) to decrease the time from the start of the induction to delivery.
To compare the efficacy of a transcervical Foley catheter with concurrent oxytocin administration compared to oxytocin infusion alone for cervical ripening and labor induction in women with premature rupture of membranes (PROM) at > 34 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcervical Foley Catheter | Experimental |
| |
| No Foley | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcervical Foley catheter | Device | Foley catheter placed through cervix for cervical ripening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hours From Placement of Foley or Initiation of Oxytocin to Delivery | The outcome measure is the mean in hours of the time from induction to delivery (up to 24 hours) | Time from induction to delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Delivery (Vaginal or Cesarean)by 24 Hours | The percent of subjects having transcervical foley catheter and percent of subjects not having transcervical foley catheter delivering within 24 hours. | from start of induction to 24 hours post start of induction |
| Cesarean Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan T Tita, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States | ||
| Christiana Care Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9692332 | Background | Wolff K, Swahn ML, Westgren M. Balloon catheter for induction of labor in nulliparous women with prelabor rupture of the membranes at term. A preliminary report. Gynecol Obstet Invest. 1998;46(1):1-4. doi: 10.1159/000009986. | |
| 36996264 | Derived | de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcervical Foley | Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin |
| FG001 | No Foley | No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcervical Foley | Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin |
| BG001 | No Foley | No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin |
| 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 | Hours From Placement of Foley or Initiation of Oxytocin to Delivery | The outcome measure is the mean in hours of the time from induction to delivery (up to 24 hours) | Posted | Mean | Standard Deviation | hours | Time from induction to delivery |
|
|
From entry into study until delivery
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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 | Transcervical Foley | Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alan Tita | UAB | 205-934-9616 | atita@uab.edu |
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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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The percent of subjects enrolled who had a cesarean at any time for any reason for delivery. |
| at delivery |
| Induction to Vaginal Delivery Interval | Mean hours from time of induction to vaginal delivery interval. | time from induction to vaginal delivery, up to 24 hours |
| Newark |
| Delaware |
| 19713 |
| United States |
| Greenville Hospital System University Medical Center | Greenville | South Carolina | 29605 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Rate of Delivery (Vaginal or Cesarean)by 24 Hours | The percent of subjects having transcervical foley catheter and percent of subjects not having transcervical foley catheter delivering within 24 hours. | Posted | Number | percentage of deliveries | from start of induction to 24 hours post start of induction |
|
|
|
| Secondary | Cesarean Rate | The percent of subjects enrolled who had a cesarean at any time for any reason for delivery. | Posted | Number | percentage of subjects | at delivery |
|
|
|
| Secondary | Induction to Vaginal Delivery Interval | Mean hours from time of induction to vaginal delivery interval. | Posted | Mean | Standard Deviation | hours | time from induction to vaginal delivery, up to 24 hours |
|
|
|
| 0 |
| 87 |
| 0 |
| 87 |
| EG001 | No Foley | No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin | 0 | 82 | 0 | 82 |
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