Trial Outcomes & Findings for Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction (NCT NCT02546193)

Results Overview

The time from when the patient is admitted to the hospital until she delivers her infant and placenta will be recorded. For the outpatient group, this will be measured by adding together the time that the patient spends in the Family Birth Center during Foley placement in the evening with the time she spends inpatient the next day during the rest of her induction until delivery.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

Delivery, approximately 16 to 30 hours after admission

Results posted on

2019-06-20

Participant Flow

Women were enrolled in the outpatient obstetric clinic approximately 2-4 weeks prior to their scheduled induction of labor.

Women were excluded from the study prior to randomization (the day before their scheduled induction of labor) due to spontaneous onset of labor or other maternal/fetal concern necessitating delivery prior to scheduled induction date.

Participant milestones

Participant milestones
Measure	Outpatient Foley Catheter Women randomized to the outpatient Foley catheter group underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.	Inpatient Usual Care Women randomized to the inpatient usual care group presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They will remained in the inpatient setting throughout their entire labor induction course.	Prospective Study Outpatient Intervention Group Women chose the outpatient Foley catheter group underwent basic history review, fetal non-stress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.
Overall Study STARTED	10	10	2
Overall Study COMPLETED	4	4	0
Overall Study NOT COMPLETED	6	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Outpatient Foley Catheter Women randomized to the outpatient Foley catheter group underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.	Inpatient Usual Care Women randomized to the inpatient usual care group presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They will remained in the inpatient setting throughout their entire labor induction course.	Prospective Study Outpatient Intervention Group Women chose the outpatient Foley catheter group underwent basic history review, fetal non-stress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.	Prospective Study Inpatient Usual Care Group Women who chose the inpatient usual care group presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal non-stress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They will remained in the inpatient setting throughout their entire labor induction course.
Overall Study Withdrawal by Subject	2	0	1	0
Overall Study Not eligible at time of induction	4	6	1	0

Baseline Characteristics

Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Outpatient Foley Catheter (Randomized & Prospective) n=4 Participants This arm reflects enrolled women who were (A) randomized to the outpatient Foley catheter group (RCT design) or (B) chose the outpatient Foley catheter group (Modified Prospective study design). NOTE: Baseline data were only collected on women who were accrued, meaning they met eligibility criteria for randomization (RCT design) or met eligibility criteria upon presentation to the Family Birth Center for induction (Modified Prospective study design). No participants in the modified Prospective study design were accrued due to screen failure. Participants underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.	Inpatient Usual Care (Randomized & Prospective) n=4 Participants This arm reflects enrolled women who were (A) randomized to the inpatient usual care group (RCT design) or (B) chose the inpatient usual care group (Modified Prospective study design). NOTE: Baseline data were only collected on women who were accrued, meaning they met eligibility criteria for randomization (RCT design) or met eligibility criteria upon presentation to the Family Birth Center for induction (Modified Prospective study design). No participants in the modified Prospective study design were accrued due to screen failure. Participants presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They remained in the inpatient setting throughout their entire labor induction course.	Total n=8 Participants Total of all reporting groups
Age, Continuous	33 years STANDARD_DEVIATION 6.3 • n=5 Participants	28 years STANDARD_DEVIATION 6.0 • n=7 Participants	30.5 years STANDARD_DEVIATION 0.18 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Delivery, approximately 16 to 30 hours after admission

The time from when the patient is admitted to the hospital until she delivers her infant and placenta will be recorded. For the outpatient group, this will be measured by adding together the time that the patient spends in the Family Birth Center during Foley placement in the evening with the time she spends inpatient the next day during the rest of her induction until delivery.

Outcome measures

Outcome measures
Measure	Outpatient Foley Catheter n=4 Participants Women randomized to the outpatient Foley catheter group underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.	Inpatient Usual Care n=4 Participants Women randomized to the inpatient usual care group presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They remained in the inpatient setting throughout their entire labor induction course.
Pre-delivery Hospitalization Time	1197 minutes Standard Deviation 267	1398 minutes Standard Deviation 264

SECONDARY outcome

Timeframe: Discharge from the hospital, approximately 2-3 days after delivery

This survey will gauge the mother's experience during her induction with regard to pain, rest, concerns during the induction, satisfaction, and willingness to recommend their particular induction setting (inpatient vs. outpatient). Questions are based on a 1-4 scale, with higher scores indicating greater satisfaction.

Outcome measures

Outcome measures
Measure	Outpatient Foley Catheter n=4 Participants Women randomized to the outpatient Foley catheter group underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.	Inpatient Usual Care n=4 Participants Women randomized to the inpatient usual care group presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They remained in the inpatient setting throughout their entire labor induction course.
Mean Score on Maternal Satisfaction Survey	3.25 score on a scale Standard Deviation 0.5	3 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: End of the third stage of labor, approximately 16 hours after admission

Method of induction: outpatient placement of Foley catheter vs. inpatient usual care induction (medication and/or Foley catheter at time of admission)

Outcome measures

Outcome measures
Measure	Outpatient Foley Catheter n=4 Participants Women randomized to the outpatient Foley catheter group underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.	Inpatient Usual Care n=4 Participants Women randomized to the inpatient usual care group presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They remained in the inpatient setting throughout their entire labor induction course.
Number of Participants Per Method of Induction Used	4 Participants	4 Participants

SECONDARY outcome

Timeframe: End of the third stage of labor, approximately 16 hours after admission

Mean dose of opioid pain medication (Fentanyl) in micrograms

Outcome measures

Outcome measures
Measure	Outpatient Foley Catheter n=4 Participants Women randomized to the outpatient Foley catheter group underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.	Inpatient Usual Care n=4 Participants Women randomized to the inpatient usual care group presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They remained in the inpatient setting throughout their entire labor induction course.
Mean Dose of Medication for Pain Relief	160 micrograms Standard Deviation 131.9	322 micrograms Standard Deviation 403.9

SECONDARY outcome

Timeframe: End of the third stage of labor, approximately 16 to 30 hours after admission

Time from admission to the hospital to delivery of the placenta.

Outcome measures

Outcome measures
Measure	Outpatient Foley Catheter n=4 Participants Women randomized to the outpatient Foley catheter group underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.	Inpatient Usual Care n=4 Participants Women randomized to the inpatient usual care group presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They remained in the inpatient setting throughout their entire labor induction course.
Mean Time of Delivery	19.94 hours Standard Deviation 4.46	23.29 hours Standard Deviation 4.39

SECONDARY outcome

Timeframe: End of the third stage of labor, approximately 16 hours after admission

Outcome measures

Outcome measures
Measure	Outpatient Foley Catheter n=4 Participants Women randomized to the outpatient Foley catheter group underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.	Inpatient Usual Care n=4 Participants Women randomized to the inpatient usual care group presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They remained in the inpatient setting throughout their entire labor induction course.
Number of Participants With Normal Spontaneous Vaginal Delivery	3 Participants	3 Participants

SECONDARY outcome

Timeframe: End of the third stage of labor, approximately 16 hours after admission

Estimated total blood loss at time of delivery in milliliters.

Outcome measures

Outcome measures
Measure	Outpatient Foley Catheter n=4 Participants Women randomized to the outpatient Foley catheter group underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.	Inpatient Usual Care n=4 Participants Women randomized to the inpatient usual care group presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They remained in the inpatient setting throughout their entire labor induction course.
Mean Estimated Blood Loss at Delivery	500 milliters Standard Deviation 334.17	562.5 milliters Standard Deviation 298.26

SECONDARY outcome

Timeframe: Final postpartum visit, approximately 42 days after delivery

Intrapartum complications defined as intrapartum fever, placental abruption, or chorioamnionitis.

Outcome measures

Outcome measures
Measure	Outpatient Foley Catheter n=4 Participants Women randomized to the outpatient Foley catheter group underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.	Inpatient Usual Care n=4 Participants Women randomized to the inpatient usual care group presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They remained in the inpatient setting throughout their entire labor induction course.
Number of Participants With Intrapartum Complications	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Final postpartum visit, approximately 42 days after delivery

Postpartum complications defined as postpartum hemorrhage, depression, urinary tract infection, wound infection, endomyometritis, mastitis, pyelonephritis, intra-abdominal infection, deep vein thrombosis, pulmonary thrombosis, cardiac complication, or fever of unknown origin.

Outcome measures

Outcome measures
Measure	Outpatient Foley Catheter n=4 Participants Women randomized to the outpatient Foley catheter group underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.	Inpatient Usual Care n=4 Participants Women randomized to the inpatient usual care group presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They remained in the inpatient setting throughout their entire labor induction course.
Number of Participants With Postpartum Complications	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Final postpartum visit, approximately 42 days after delivery

Defined as readmission to the hospital for any reason within 6 weeks from the date of delivery.