Trial Outcomes & Findings for FOLCROM Trial: Foley Catheter in Rupture of Membranes (NCT NCT01973036)
NCT ID: NCT01973036
Last Updated: 2018-09-24
Results Overview
Time from induction (i.e., start time of Foley catheter or oxytocin) to delivery (hours), analyzed for all deliveries
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
201 participants
Primary outcome timeframe
Time from induction to delivery (average 14.2 hours)
Results posted on
2018-09-24
Participant Flow
Women presenting to labor \& delivery with ruptured membranes with an unfavorable cervix based on sterile digital exam at greater than or equal to 34 weeks were approached by a study team member for participation.
Participant milestones
| Measure |
Oxytocin
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
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|---|---|---|
|
Overall Study
STARTED
|
108
|
93
|
|
Overall Study
Received Assigned Intervention
|
113
|
88
|
|
Overall Study
COMPLETED
|
108
|
93
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FOLCROM Trial: Foley Catheter in Rupture of Membranes
Baseline characteristics by cohort
| Measure |
Oxytocin
n=108 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=93 Participants
A 30cc/16 French (16F) foley catheter will be inserted by the provider under direct visualization or by palpation, ensuring that the catheter is appropriately and adequately positioned. Oxytocin will be administered concurrently at a rate of 2 milliunits/milliliter (as noted under oxytocin active comparator). If the catheter remains in place after 12 hours, it will be deflated and removed and oxytocin infusion will continue.
Foley Catheter: Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuri
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27 years
n=5 Participants
|
27.5 years
n=7 Participants
|
27.25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from induction to delivery (average 14.2 hours)Time from induction (i.e., start time of Foley catheter or oxytocin) to delivery (hours), analyzed for all deliveries
Outcome measures
| Measure |
Oxytocin
n=108 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=93 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
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|---|---|---|
|
Time From Induction of Labor Until Delivery
|
14.4 hours
Standard Deviation 7.9
|
13.9 hours
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Duration of Labor (average 4.8 hours)Population: The number of participants analyzed excludes patients who were hospitalized with PPROM prior to 34 0/7 weeks (i.e., four patients in the Oxytocin arm and six patients in the Foley Catheter arm).
Number of participants with chorioamnionitis excluding all those who were hospitalized with preterm premature rupture of membranes (PPROM) prior to 34 0/7 weeks. Chorioamnionitis was defined as temperature 38°C (or 100.4°F) or greater with at least two of the following: purulent discharge, maternal tachycardia (heart rate 100 beats per minute or greater), fetal tachycardia (heart rate 160 beats per minute or greater), foul odor of the amniotic fluid, or maternal leukocytosis (greater than 15,000 cells/mL3). Without Restriction = Chorioamnionitis was defined as temperature 38°C or greater and one of the following: purulent discharge, maternal tachycardia, fetal tachycardia, foul odor of the amniotic fluid, or maternal leukocytosis. With Restriction = Chorioamnionitis was defined as temperature 38°C or greater and two of the following: purulent discharge, maternal tachycardia, fetal tachycardia, foul odor of the amniotic fluid, or maternal leukocytosis.
Outcome measures
| Measure |
Oxytocin
n=104 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=87 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
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|---|---|---|
|
Number of Participants With Chorioamnionitis
Without Restrictions
|
2 Participants
|
9 Participants
|
|
Number of Participants With Chorioamnionitis
With Restrictions
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Duration of Labor (average 4.8 hours)Outcome measures
| Measure |
Oxytocin
n=108 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=93 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
|---|---|---|
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Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin
|
46 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Duration of Labor (average 4.8 hours)Outcome measures
| Measure |
Oxytocin
n=108 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=93 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
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|---|---|---|
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Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin
|
80 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: Duration of Labor (average 4.8 hours)Outcome measures
| Measure |
Oxytocin
n=80 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=61 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
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|---|---|---|
|
Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries
First Stage
|
130 Minutes
Interval 76.5 to 226.0
|
188 Minutes
Interval 111.0 to 294.0
|
|
Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries
Second Stage
|
39 Minutes
Interval 15.0 to 88.0
|
23 Minutes
Interval 11.0 to 72.0
|
|
Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries
Third Stage
|
5 Minutes
Interval 3.0 to 6.0
|
5 Minutes
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: Duration of Labor (average 4.8 hours)This will be defined by a combination of provider documentation and cervical dilation of ≤4cm/90% effaced or ≤5cm/any effacement after a minimum of 12 hours of oxytocin in the setting of adequate contraction. One patient was missing information for failed induction.
Outcome measures
| Measure |
Oxytocin
n=21 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=25 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
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|---|---|---|
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Rate of Failed Induction of Labor as the Indication for Cesarean
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Duration of hospital stay (average 3.4 days)Endomyometritis defined as: Temperature ≥100.4°F + one of the following: fundal tenderness, maternal tachycardia (Heart Rate ≥ 100 BPM), purulent cervical discharge and no other source of fever
Outcome measures
| Measure |
Oxytocin
n=108 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=93 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
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|---|---|---|
|
Rate of Endomyometritis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Duration of hospital stay (average 3.4 days)Outcome measures
| Measure |
Oxytocin
n=108 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=93 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
|---|---|---|
|
Maternal Length of Stay, From Admission to Discharge (Days)
|
3 days
Interval 2.0 to 3.0
|
3 days
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: Duration of hospital stay (average 3.4 days)Apgar is a test for assessing a newborn shortly after birth to determine if extra medical care or emergency care may be needed. Usually administered at 1 and 5 minutes after birth, the test includes assessment of Appearance, Pulse, Grimace, Activity and Respiration. Scores range from 0 - 10.
Outcome measures
| Measure |
Oxytocin
n=108 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=93 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
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|---|---|---|
|
Rate of Five Minute Apgar Score < 5
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 1 hour of deliveryOutcome measures
| Measure |
Oxytocin
n=108 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=93 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
|---|---|---|
|
Arterial Cord Blood Gas (pH), When Obtained
|
7.25 pH
Standard Deviation 0.07
|
7.26 pH
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Duration of hospital stay (average 3.4 days)Neonatal sepsis \[positive blood or cerebrospinal fluid (CSF) cultures\]
Outcome measures
| Measure |
Oxytocin
n=108 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=93 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
|---|---|---|
|
Rate of Neonatal Sepsis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Duration of hospital stay (average 3.4 days)Outcome measures
| Measure |
Oxytocin
n=108 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=93 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
|---|---|---|
|
Neonatal Intensive Care Unit (NICU) Admission Rate
|
20 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Duration of hospital stay (average 3.4 days)Outcome measures
| Measure |
Oxytocin
n=108 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=93 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
|---|---|---|
|
Neonatal Length of Stay
|
49.7 hours
Standard Deviation 16.9
|
52.4 hours
Standard Deviation 20.0
|
SECONDARY outcome
Timeframe: Duration of hospital stay (average 3.4 days)Chorioamnionitis/funisitis as determined by the pathologist examining the placenta
Outcome measures
| Measure |
Oxytocin
n=108 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=93 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
|---|---|---|
|
Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Time from induction to delivery (average 14.2 hours)Time from induction to delivery (hours) excluding all those who were hospitalized with PPROM prior to 34 0/7 weeks
Outcome measures
| Measure |
Oxytocin
n=104 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=87 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
|---|---|---|
|
Time From Induction to Delivery (Hours)
|
14.23 hours
Standard Deviation 8.19
|
14.16 hours
Standard Deviation 6.97
|
SECONDARY outcome
Timeframe: Duration of hospital stay (average 3.4 days)Outcome measures
| Measure |
Oxytocin
n=108 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=93 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
|---|---|---|
|
Overall Cesarean Delivery
|
21 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Duration of hospital stay (average 3.4 days)Chorioamnionitis defined as (Temperature greater than or equal to 100.4 degrees fahrenheit or 38 degrees celsius) with at least 2 of the following: uterine tenderness, maternal tachycardia (HR greater than or equal to 100 bpm), fetal tachycardia (HR greater than or equal to 160bpm), foul odor of the amniotic fluid, or maternal leukocytosis (greater than 15000 cells/cubic milliliter)
Outcome measures
| Measure |
Oxytocin
n=108 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=93 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
|---|---|---|
|
Rate of Chorioamnionitis
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Duration of hospital stay (average 3.4 days)Outcome measures
| Measure |
Oxytocin
n=108 Participants
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
Foley Catheter and Oxytocin
n=93 Participants
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
|
|---|---|---|
|
Maternal Length of Stay From Delivery to Discharge (Hours)
|
48.1 hours
Interval 38.8 to 57.2
|
47.8 hours
Interval 41.2 to 58.7
|
Adverse Events
Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Foley Catheter and Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place