Trial Outcomes & Findings for Outpatient Foley For Starting Induction of Labor at TErm (NCT NCT02756689)
NCT ID: NCT02756689
Last Updated: 2019-07-09
Results Overview
COMPLETED
NA
129 participants
From baseline to the time of delivery (baseline is from admission), up to 7 days
2019-07-09
Participant Flow
One additional patient was already scheduled to participate when the study met the projected number (128). The final (#129 patient) was offered participation in the study since she had already been scheduled for a study visit and possible induction of labor.
Participant milestones
| Measure |
Inpatient Group
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
65
|
|
Overall Study
COMPLETED
|
64
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Outpatient Foley For Starting Induction of Labor at TErm
Baseline characteristics by cohort
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.8 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
26.6 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
26.2 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity
|
64 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
58 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to the time of delivery (baseline is from admission), up to 7 daysOutcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Total Time From Admission to Delivery
|
13.5 hours
Standard Deviation 7.0
|
12.4 hours
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: From admission time to the hospital until discharge from the hospital, up to 7 daysOutcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Total Hospital Duration
|
2.7 days
Standard Deviation 0.6
|
2.6 days
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: From placement of Foley bulb to 24 hours.Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Number of Participants Using Acetaminophen
|
6 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: From placement of Foley bulb to 24 hours.Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Number of Participants Calling the Obstetrical Triage Unit
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From placement of Foley bulb to 24 hours.Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Number of Participants Admitted Prior to the Scheduled Induction of Labor Time
|
3 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From placement of Foley bulb to 24 hours.Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Number of Participants With Spontaneous Rupture of Membranes Between Foley Bulb Placement and Admission
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From placement until 30 minutes.Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Nonreassuring Fetal Heart Tracings 30-minutes After Foley Bulb Placement.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed from baseline to delivery, up to 3 daysOutcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Total Duration of Time of Neuraxial Anesthesia Use
|
8.7 hours
Standard Deviation 6.3
|
8.4 hours
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Assessed from baseline to delivery, up to 3 daysOutcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Total Duration of Time From Rupture of Membranes Until Delivery
|
6.2 hours
Standard Deviation 4.4
|
5.5 hours
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Assessed from baseline to delivery, up to 3 daysOutcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Maximum Oxytocin Rate
|
16.4 milliunits/min
Standard Deviation 9
|
17.8 milliunits/min
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Assessed from baseline to delivery, up to 3 daysOutcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Highest Maternal Intrapartum Temperature
|
36.8 Celsius
Standard Deviation 0.4
|
36.7 Celsius
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Assessed from baseline to delivery.Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Number of Participants With Chorioamnionitis
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Assessed from baseline to delivery.Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Number of Participants With Meconium-stained Fluid
|
11 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Assessed at delivery.Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Number of Participants With Neonates With Shoulder Dystocia
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Assessed from baseline to delivery.Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Number of Participants Who Had a Cesarean Delivery
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Assessed at delivery.Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Number of Participants With an Operative Vaginal Delivery
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Assessed at delivery.Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Postpartum Hemorrhage
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed from delivery until 30 days post-discharge.Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Number of Participants With Endometritis
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Assessed from time of discharge until 30 days post-discharge.Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Number of Participants With Readmission Within 30 Days
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Assessed at time of delivery up to 5-minutes post-delivery.Apgar scores are assigned to all births. These are universally performed and assigned in the United States. The scoring system is between 0-10. 0 is the minimum score and 10 is the maximum. Lower scores are worse than higher scores.
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Number of Neonates With a 5-minute Apgar Score Less Than 7
|
1 Neonates
|
0 Neonates
|
SECONDARY outcome
Timeframe: Assessed at time of delivery up to 5-minutes post-delivery.Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Number of Neonates With Umbilical Artery Cord pH < 7.1
|
4 neonates
|
1 neonates
|
SECONDARY outcome
Timeframe: Assessed at time of delivery up to 5-minutes post-delivery.Base deficit is a lab value.
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Number of Neonates With an Umbilical Cord Artery Base Deficit Less Than Negative 12
|
1 neonates
|
0 neonates
|
SECONDARY outcome
Timeframe: Assessed at time of delivery up to time of neonatal discharge, up to 30 days.Cephalohematomas, subgaleal hematomas, fracture of the clavicle, and scalp lacerations
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Number of Neonates With Birth Injuries
|
2 neonates
|
1 neonates
|
SECONDARY outcome
Timeframe: Assessed at time of delivery up to time of neonatal discharge, up to 30-daysThe rates of neonatal intensive care unit admissions will be calculated.
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Number of Neonates Admitted to the Neonatal Intensive Care Unit Admissions
|
5 neonates
|
5 neonates
|
SECONDARY outcome
Timeframe: At discharge.Population: Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Outcome measures
| Measure |
Inpatient Group
n=65 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=64 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Patient Satisfaction Six Simple Questions, Q1
|
7 units on a scale
Interval 7.0 to 7.0
|
7 units on a scale
Interval 6.0 to 7.0
|
SECONDARY outcome
Timeframe: At dischargePopulation: Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Assessed through validated survey (Six simple questions, Q-2). Question 2: The person(s) responsible for my care are/were caring and compassionate. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Patient Satisfaction (Six Simple Questions, Question 2)
|
7 units on a scale
Interval 7.0 to 7.0
|
7 units on a scale
Interval 7.0 to 7.0
|
SECONDARY outcome
Timeframe: At dischargePopulation: Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 3: Problems that have arisen up to now have not been dealt with effectively. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Patient Satisfaction (Six Simple Questions, Question 3)
|
1 units on a scale
Interval 1.0 to 1.5
|
1 units on a scale
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At dischargePopulation: Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 4: My needs have been addressed with appropriate consideration for my time. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Patient Satisfaction (Six Simple Questions, Question 4)
|
7 units on a scale
Interval 7.0 to 7.0
|
7 units on a scale
Interval 7.0 to 7.0
|
SECONDARY outcome
Timeframe: At dischargePopulation: Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 5: The overall organization of my ca re has not been appropiate. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Patient Satisfaction (Six Simple Questions, Question 5)
|
1 units on a scale
Interval 1.0 to 1.0
|
1 units on a scale
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At dischargePopulation: Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 6: I would choose the same type of care for my next pregnancy. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Patient Satisfaction (Six Simple Questions, Question 6)
|
7 units on a scale
Interval 6.0 to 7.0
|
7 units on a scale
Interval 7.0 to 7.0
|
SECONDARY outcome
Timeframe: At dischargePopulation: Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3
Assessed through a validated survey, Lady-X. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 1: Presence of healthcare professionals during my birth. Scale 1-3. 1 = At all times, 2 = Most of the time, 3 = rarely Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Patient Satisfaction (Lady-X Survey, Question 1)
|
1 units on a scale
Interval 1.0 to 1.0
|
1 units on a scale
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At dischargePopulation: Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3
Assessed through a validated survey, Lady-X Survey. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 2: Information given by the healthcare professionals during childbirth. Scale 1-3. 1 = I felt very well informed by the healthcare professionals, 2 = I felt adequately informed by the healthcare professionals, 3 = I felt inadequately informed by the healthcare professionals. Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Patient Satisfaction (Lady-X Survey, Question 2)
|
1 units on a scale
Interval 1.0 to 1.0
|
1 units on a scale
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At dischargePopulation: Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3
Assessed through a validated survey, Lady-X Survey. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 3: Taking your wishes seriously during childbirth. Scale 1-3. 1 = Very seriously, 2 = sufficiently, 3 = insufficiently Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Patient Satisfaction (Lady-X Survey, Question 3)
|
1 units on a scale
Interval 1.0 to 1.0
|
1 units on a scale
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At dischargePopulation: Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3
Assessed through a validated survey, Lady-X Survey. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 4: Emotional support by healthcare professionals during childbirth. Scale 1-3. 1 = Very well supported, 2 = adequately supported, 3 = inadequately supported. Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Patient Satisfaction (Lady-X Survey, Question 4)
|
1 units on a scale
Interval 1.0 to 1.0
|
1 units on a scale
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At dischargePopulation: Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3
Assessed through a validated survey, Lady-X. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 5: Feeling of security during childbirth: Scale 1-3. 1 = very safe, 2 = sufficiently safe, 3 = insufficiently safe. Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Patient Satisfaction (Lady-X Survey, Question 5)
|
1 units on a scale
Interval 1.0 to 1.0
|
1 units on a scale
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At dischargePopulation: Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3
Assessed through a validated survey, Lady-X. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 6: Worries about the health of your child during childbirth. Scale 1-3; 1 = not worried, 2 = somewhat worried, 3 = very worried. Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Patient Satisfaction (Lady-X Survey, Question 6)
|
1 units on a scale
Interval 1.0 to 2.0
|
1 units on a scale
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: At dischargePopulation: Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3
Assessed through a validated survey, Lady-X. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 7: Time until first contact with your child. Scale 1-3. 1 = Did not take long, 2 = Took quite a long time, 3 = Took a very long time. Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Patient Satisfaction (Lady-X, Question 7)
|
1 units on a scale
Interval 1.0 to 1.0
|
1 units on a scale
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At dischargePopulation: Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction. Ranges: 0-100 Best score: 100
Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of Foley balloon, and likeliness of recommending method of induction to a friend. Questions 1: Worst amount of pain experienced during labor. Scale 0-100. 1 = no pain, 100 = pain as bad as it could possibly be. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction. Ranges: 0-100 Best score: 100 Worst score: 0
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Patient Satisfaction (Labor Pain Scale, Question 1)
|
59.5 units on a scale
Interval 40.0 to 85.0
|
70 units on a scale
Interval 50.0 to 90.0
|
SECONDARY outcome
Timeframe: At dischargePopulation: Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction. Ranges: 0-100 Best score: 100 Worst score: 0
Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of Foley balloon, and likeliness of recommending method of induction to a friend. Questions 2: Overall pain experienced during labor. Scale 0-100. 1 = no pain, 100 = pain as bad as it could possibly be. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction. Ranges: 0-100 Best score: 100 Worst score: 0
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Patient Satisfaction (Labor Pain Scale, Question 2)
|
50 units on a scale
Interval 40.0 to 80.5
|
70 units on a scale
Interval 50.0 to 87.0
|
SECONDARY outcome
Timeframe: At dischargePopulation: Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction. Ranges: 0-100 Best score: 100 Worst score: 0
Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of Foley balloon, and likeliness of recommending method of induction to a friend. Questions 3: Worse amount of pain experienced during the placement of the Foley balloon. Scale 0-100. 1 = no pain, 100 = pain as bad as it could possibly be. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction. Ranges: 0-100 Best score: 100 Worst score: 0
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Patient Satisfaction (Labor Pain Scale, Question 3)
|
20 units on a scale
Interval 5.0 to 50.0
|
15 units on a scale
Interval 5.0 to 50.0
|
SECONDARY outcome
Timeframe: At dischargePopulation: Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction. Ranges: 0-100 Best score: 100 Worst score: 0
Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of Foley balloon, and likeliness of recommending method of induction to a friend. Questions 4: How likely are you to recommend your method of induction to a friend or family member. Scale 0-100. 0= very unlikely, 100= very likely. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction. Ranges: 0-100 Best score: 100 Worst score: 0
Outcome measures
| Measure |
Inpatient Group
n=64 Participants
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting.
|
Outpatient Group (Intervention)
n=65 Participants
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
|
|---|---|---|
|
Patient Satisfaction (Labor Pain Scale, Question 4)
|
99 units on a scale
Interval 65.0 to 100.0
|
99 units on a scale
Interval 80.0 to 100.0
|
Adverse Events
Inpatient Group
Outpatient Group
Serious adverse events
| Measure |
Inpatient Group
n=64 participants at risk
Adverse Events: none
|
Outpatient Group
n=65 participants at risk
Adverse events: none
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Endometritis
|
1.6%
1/64 • Number of events 1 • Enrollment to 30 days discharge
|
1.5%
1/65 • Number of events 1 • Enrollment to 30 days discharge
|
|
Pregnancy, puerperium and perinatal conditions
Chorioamnionitis
|
4.7%
3/64 • Number of events 3 • Enrollment to 30 days discharge
|
4.6%
3/65 • Number of events 3 • Enrollment to 30 days discharge
|
|
Pregnancy, puerperium and perinatal conditions
Readmission within 30 days of discharge
|
0.00%
0/64 • Enrollment to 30 days discharge
|
1.5%
1/65 • Number of events 1 • Enrollment to 30 days discharge
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical cord arterial pH less than 7.1
|
6.2%
4/64 • Number of events 4 • Enrollment to 30 days discharge
|
1.5%
1/65 • Number of events 1 • Enrollment to 30 days discharge
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical cord arterial base deficit greater than 12
|
1.6%
1/64 • Number of events 1 • Enrollment to 30 days discharge
|
0.00%
0/65 • Enrollment to 30 days discharge
|
|
Pregnancy, puerperium and perinatal conditions
Birth injuries
|
3.1%
2/64 • Number of events 2 • Enrollment to 30 days discharge
|
1.5%
1/65 • Number of events 1 • Enrollment to 30 days discharge
|
|
Pregnancy, puerperium and perinatal conditions
Admission to the NICU
|
7.8%
5/64 • Number of events 5 • Enrollment to 30 days discharge
|
7.7%
5/65 • Number of events 5 • Enrollment to 30 days discharge
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place