Trial Outcomes & Findings for Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor (NCT NCT02273115)

Results Overview

The rate of women who deliver in less than or equal to 24 hours from Foley placement.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

323 participants

Primary outcome timeframe

Within 24 hours

Results posted on

2017-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Nulliparous - Foley and Oxytocin Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter	Multi(Primi)Parous - Foley Only Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Multi(Primi)Parous - Foley and Oxytocin Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter	Nulliparous - Foley Only Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter
Overall Study STARTED	90	67	72	94
Overall Study COMPLETED	90	67	71	94
Overall Study NOT COMPLETED	0	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nulliparous - Foley Only n=94 Participants Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Nulliparous - Foley and Oxytocin n=90 Participants Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter	Multi(Primi)Parous - Foley Only n=67 Participants Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Multi(Primi)Parous - Foley and Oxytocin n=71 Participants Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter	Total n=322 Participants Total of all reporting groups
Age, Continuous	27 years STANDARD_DEVIATION 5 • n=93 Participants	27 years STANDARD_DEVIATION 6 • n=4 Participants	31 years STANDARD_DEVIATION 5 • n=27 Participants	31 years STANDARD_DEVIATION 5 • n=483 Participants	29 years STANDARD_DEVIATION 1 • n=36 Participants
Sex: Female, Male Female	94 Participants n=93 Participants	90 Participants n=4 Participants	67 Participants n=27 Participants	71 Participants n=483 Participants	322 Participants n=36 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	6 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	0 Participants n=483 Participants	12 Participants n=36 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black or African American	41 Participants n=93 Participants	30 Participants n=4 Participants	39 Participants n=27 Participants	35 Participants n=483 Participants	145 Participants n=36 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	38 Participants n=93 Participants	49 Participants n=4 Participants	16 Participants n=27 Participants	29 Participants n=483 Participants	132 Participants n=36 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	7 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants	5 Participants n=483 Participants	25 Participants n=36 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	2 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants	8 Participants n=36 Participants

PRIMARY outcome

Timeframe: Within 24 hours

The rate of women who deliver in less than or equal to 24 hours from Foley placement.

Outcome measures

Outcome measures
Measure	Nulliparous - Foley Only n=94 Participants Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Nulliparous - Foley and Oxytocin n=90 Participants Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter	Multi(Primi)Parous - Foley Only n=67 Participants Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Multi(Primi)Parous - Foley and Oxytocin n=71 Participants Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter
Delivery Rate	40 Participants	58 Participants	48 Participants	62 Participants

SECONDARY outcome

Timeframe: Within 12 hours

Number of participants with a time from Foley placement to delivery less than or equal to 12 hours

Outcome measures

Outcome measures
Measure	Nulliparous - Foley Only n=94 Participants Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Nulliparous - Foley and Oxytocin n=90 Participants Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter	Multi(Primi)Parous - Foley Only n=67 Participants Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Multi(Primi)Parous - Foley and Oxytocin n=71 Participants Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter
Number of Participants With Time to Delivery Achieved Within 12 Hours	2 Participants	7 Participants	13 Participants	23 Participants

SECONDARY outcome

Timeframe: On average, 24-36 hours

Outcome measures

Outcome measures
Measure	Nulliparous - Foley Only n=94 Participants Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Nulliparous - Foley and Oxytocin n=90 Participants Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter	Multi(Primi)Parous - Foley Only n=67 Participants Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Multi(Primi)Parous - Foley and Oxytocin n=71 Participants Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter
Total Time to Delivery	26.1 hours Interval 20.5 to 33.7	20.9 hours Interval 16.2 to 27.0	18.6 hours Interval 13.5 to 25.2	14.9 hours Interval 10.7 to 21.0

SECONDARY outcome

Timeframe: 0-12 hours

Outcome measures

Outcome measures
Measure	Nulliparous - Foley Only n=94 Participants Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Nulliparous - Foley and Oxytocin n=90 Participants Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter	Multi(Primi)Parous - Foley Only n=67 Participants Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Multi(Primi)Parous - Foley and Oxytocin n=71 Participants Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter
Time to Foley Expulsion	11.8 hours Interval 7.8 to 12.3	7.2 hours Interval 4.8 to 11.8	7.9 hours Interval 4.5 to 12.0	5.8 hours Interval 4.1 to 8.4

SECONDARY outcome

Timeframe: Assessed after delivery, on average occurring between 24-48 hours

Outcome measures

Outcome measures
Measure	Nulliparous - Foley Only n=94 Participants Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Nulliparous - Foley and Oxytocin n=90 Participants Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter	Multi(Primi)Parous - Foley Only n=67 Participants Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Multi(Primi)Parous - Foley and Oxytocin n=71 Participants Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter
Number of Vaginal Deliveries	59 Participants	49 Participants	54 Participants	59 Participants

SECONDARY outcome

Timeframe: Assessed during the induction, labor and delivery period, on average occurring between 24-48 hours

Regional analgesia used during Foley ripening

Outcome measures

Outcome measures
Measure	Nulliparous - Foley Only n=94 Participants Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Nulliparous - Foley and Oxytocin n=90 Participants Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter	Multi(Primi)Parous - Foley Only n=67 Participants Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Multi(Primi)Parous - Foley and Oxytocin n=71 Participants Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter
Regional Analgesia	2 Participants	13 Participants	1 Participants	11 Participants

SECONDARY outcome

Timeframe: Assessed during induction, labor, delivery, and postpartum. On average, this would be over a 3-7 day time period

Outcome measures

Outcome measures
Measure	Nulliparous - Foley Only n=94 Participants Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Nulliparous - Foley and Oxytocin n=90 Participants Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter	Multi(Primi)Parous - Foley Only n=67 Participants Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Multi(Primi)Parous - Foley and Oxytocin n=71 Participants Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter
Obstetric Complications Postpartum hemorrhage	14 Participants	11 Participants	8 Participants	6 Participants
Obstetric Complications Tachysystole	8 Participants	10 Participants	1 Participants	3 Participants
Obstetric Complications Chorioamnionitis	17 Participants	11 Participants	3 Participants	2 Participants
Obstetric Complications Meconium	14 Participants	20 Participants	8 Participants	5 Participants
Obstetric Complications Uterine rupture	0 Participants	0 Participants	0 Participants	0 Participants
Obstetric Complications Maternal death	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Assessed from birth through discharge, on average 2 days after birth

Outcome measures

Outcome measures
Measure	Nulliparous - Foley Only n=94 Participants Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Nulliparous - Foley and Oxytocin n=90 Participants Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter	Multi(Primi)Parous - Foley Only n=67 Participants Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Multi(Primi)Parous - Foley and Oxytocin n=71 Participants Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter
Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 NICU admission	27 Participants	23 Participants	12 Participants	11 Participants
Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 5-minute Apgar score <7	5 Participants	0 Participants	2 Participants	1 Participants
Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 Macrosomia	9 Participants	8 Participants	3 Participants	6 Participants

SECONDARY outcome

Timeframe: Assessed from birth through discharge, on average 2 days after birth

Outcome measures

Outcome measures
Measure	Nulliparous - Foley Only n=94 Participants Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Nulliparous - Foley and Oxytocin n=90 Participants Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter	Multi(Primi)Parous - Foley Only n=67 Participants Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Multi(Primi)Parous - Foley and Oxytocin n=71 Participants Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter
Neonatal Outcome: Neonatal Weight	3301 grams Standard Deviation 524	3278 grams Standard Deviation 570	3177 grams Standard Deviation 523	3164 grams Standard Deviation 579

Adverse Events

Nulliparous - Foley Only

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Nulliparous - Foley and Oxytocin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Multi(Primi)Parous - Foley Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Multi(Primi)Parous - Foley and Oxytocin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nulliparous - Foley Only n=94 participants at risk Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Nulliparous - Foley and Oxytocin n=90 participants at risk Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter	Multi(Primi)Parous - Foley Only n=67 participants at risk Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Transcervical Foley catheter	Multi(Primi)Parous - Foley and Oxytocin n=71 participants at risk Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Oxytocin Transcervical Foley catheter
Product Issues Foley balloon rupture	1.1% 1/94 • Number of events 1	0.00% 0/90	0.00% 0/67	1.4% 1/71 • Number of events 1

Additional Information

Dr. Corina Schoen

University of Massachusetts - Baystate

Phone: 4137543470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place