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The purpose of this research study is to compare induction of labor using a foley catheter bulb with a low dose of oxytocin versus a foley catheter bulb with an increasing dose of oxytocin. A foley catheter bulb with or without oxytocin is a common method of labor induction in patients whose cervix is not significantly dilated or thinned out (effaced). Oxytocin (pitocin) is a medicine used to increase the number and strength of the womb's contractions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| foley bulb induction with low dose pitocin | Active Comparator | Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes. |
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| foley bulb with standard incremental pitocin infusion protocol | Active Comparator | Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pitocin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to the Second Stage of Labor | The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus. | foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days) |
| Time to Delivery | Time from foley balloon placement until neonate delivery | foley bulb placement until delivery (during admission for delivery, up to approximately 4 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Cesarean Delivery | Number of participants having a cesarean delivery | during admission for delivery, up to approximately 4 days |
| Time to Active Labor | Active labor was defined as the presence of regular, painful contractions and a minimum of 2 cm cervical dilation and complete effacement in nulliparous women or a minimum of 4 cm cervical dilation in multiparous women. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chad Grotegut, MD | Duke University | Principal Investigator |
| Brennan Fitzpatrick, MD | Duke University | Principal Investigator |
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121 subjects enrolled. Of the 121 subjects 2 were screen failures and 2 subject were excluded after consent due to meeting exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Foley Bulb Induction With Low Dose Pitocin | Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes. pitocin |
| FG001 | Foley Bulb With Standard Incremental Pitocin Infusion Protocol | Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min. pitocin |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Foley Bulb Induction With Low Dose Pitocin | Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes. pitocin |
| BG001 | Foley Bulb With Standard Incremental Pitocin Infusion Protocol |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Time to the Second Stage of Labor | The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus. | Posted | Mean | Inter-Quartile Range | hours | foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 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 | Foley Bulb Induction With Low Dose Pitocin | Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes. pitocin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chad Grotegut , MD | Duke University Medical Center | chad.grotegut@dm.duke.edu |
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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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| during admission for delivery, up to approximately 4 days |
| Time to Foley Expulsion or Removal | Time from foley balloon placement until the expulsion or removal of the foley balloon. | foley bulb placement until removal, up to 10 hours |
| Incidence of Uterine Hyperstimulation | Uterine hyperstimulation (tachysystole) was defined as uterine contractions occurring greater than 12 in 20 minutes. | during admission for delivery, up to approximately 4 days |
| Neonatal Outcome: Birthweight | at time of birth (0 to 1 hour) |
| Neonatal Outcome: Placental Abruption | number of participants with placental abruption | during admission for delivery, up to approximately 4 days |
| Neonatal Outcome: Late Fetal Heart Rate Decelerations | Late fetal heart rate decelerations were defined as a gradual decrease in the fetal heart rate associated with uterine contraction with the nadir of the deceleration occurring after the peak of the contraction. | during admission for delivery, up to approximately 4 days |
Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min. pitocin |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Primary | Time to Delivery | Time from foley balloon placement until neonate delivery | Posted | Median | Inter-Quartile Range | hours | foley bulb placement until delivery (during admission for delivery, up to approximately 4 days) |
|
|
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| Secondary | Rate of Cesarean Delivery | Number of participants having a cesarean delivery | Posted | Number | participants | during admission for delivery, up to approximately 4 days |
|
|
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| Secondary | Time to Active Labor | Active labor was defined as the presence of regular, painful contractions and a minimum of 2 cm cervical dilation and complete effacement in nulliparous women or a minimum of 4 cm cervical dilation in multiparous women. | Posted | Median | Inter-Quartile Range | hours | during admission for delivery, up to approximately 4 days |
|
|
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| Secondary | Time to Foley Expulsion or Removal | Time from foley balloon placement until the expulsion or removal of the foley balloon. | Posted | Median | Inter-Quartile Range | hours | foley bulb placement until removal, up to 10 hours |
|
|
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| Secondary | Incidence of Uterine Hyperstimulation | Uterine hyperstimulation (tachysystole) was defined as uterine contractions occurring greater than 12 in 20 minutes. | Posted | Number | participants | during admission for delivery, up to approximately 4 days |
|
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| Secondary | Neonatal Outcome: Birthweight | Posted | Mean | Standard Deviation | gram | at time of birth (0 to 1 hour) |
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| Secondary | Neonatal Outcome: Placental Abruption | number of participants with placental abruption | Posted | Number | participants | during admission for delivery, up to approximately 4 days |
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| Secondary | Neonatal Outcome: Late Fetal Heart Rate Decelerations | Late fetal heart rate decelerations were defined as a gradual decrease in the fetal heart rate associated with uterine contraction with the nadir of the deceleration occurring after the peak of the contraction. | Posted | Number | neonates | during admission for delivery, up to approximately 4 days |
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| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | Foley Bulb With Standard Incremental Pitocin Infusion Protocol | Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min. pitocin | 0 | 59 | 0 | 59 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |