Inpatient Versus Outpatient Foley Cervical Ripening Study

Study Overview
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Brief Summary
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To compare the efficacy and safety of cervical ripening with transcervical Foley catheter in inpatient vs outpatient setting

Detailed Description
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The aim of the current study is to compare the efficacy and safety of cervical ripening with transcervical Foley catheter in inpatient vs outpatient setting in a diverse, urban population within the United States. We hypothesize that there will be no differences in time-to-delivery, failed induction rates, cesarean section rates, or maternal/neonatal morbidity and that there will be no differences in total length of stay (LOS), hours of sleep, active labor duration, and perceived satisfaction between groups.

Official Title
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Inpatient Versus Outpatient Foley Cervical Ripening Study

Conditions
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Induced; Birth

Intervention / Treatment
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* Behavioral: Outpatient
* Behavioral: Inpatient


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for Induction of Labor is present Gestational age > 37 completed weeks with absence of comorbidities with an optimal dating (ultrasonography was performed before 22 weeks gestation) Singleton fetus in cephalic presentation confirmed with an ultrasound at the time of presentation for induction of labor Cervical exam with Bishop Score <6 Intact membranes Normal vital signs (blood pressure < 140/90, normal body temperature) at the time of presentation for Induction of Labor and within the last 24 hours Maternal age ≥18 years of age Exclusion Criteria: Any contraindication for vaginal birth by institutional policy Multiple gestation History of cesarean delivery Oligohydramnios/polyhydramnios/anhydramnios (MVP <2cm) Rupture of membranes Poorly controlled diabetes (Hgb A1C>8% and/or fingerstick glucose above target >50% of the time in the past week) Poorly controlled chronic hypertension, gestational hypertension or preeclampsia (patient requiring IV antihypertensives within 4 hours of arrival) Vaginal bleeding Any conditions that require continuous electronic fetal monitoring either by institutional policy or provider determination (intrahepatic cholestasis of pregnancy, intrauterine growth restriction, abnormal non-stress test, others) Fetal anomaly with anticipated neonatal intensive care unit admission Fetal demise HIV infection, presence of genital herpetic lesion History of substance abuse during this pregnancy History of precipitous delivery (delivery <3hrs from onset of labor) Poor access to care (social, distance to hospital > 45 min, limited transportation) Poor social situation, history of domestic violence, untreated/uncontrolled psychiatric condition Inability to give informed consent, history of mental retardation Strong preference for inpatient management Inability to understand English or Spanish

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two cohort double blinded clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatients with a transcervical Foley catheter<br>Women with a transcervical Foley catheter in place that will spend the night at home. | Behavioral: Outpatient<br>* The offered (studied) intervention will be allowing the women with a transcervical Foley catheter in place to spend the night at home.<br>|
| Active Comparator: Inpatients with a transcervical Foley catheter<br>Women to be admitted to the hospital overnight which has been a standard of care. | Behavioral: Inpatient<br>* Women with a transcervical Foley catheter to be admitted to the hospital overnight which has been a standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Foley catheter extrusion | Antepartum time of Foley catheter extrusion before patient being brought to labor | within 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bishop score | Bishop scoring system used to consider having cervical ripening.Women with favorable cervices (BS 8 or more) are considered to have a cervix ripe and ready to proceed to induction. BS <6 are considered unripe, and therefore may benefit from additional ripening modalities | during labor | 
| Total time in cervical ripening | Measure of total time in cervical ripening | from labor induction to delivery time | 
| Total time slept during pre-induction | Total time slept during pre-induction | during labor | 
| Total time in hospital | Total time in hospital | no max but an average of 3 days | 
| Analgesia used during pre-induction | Analgesia used during pre-induction | within 24 hours before Pitocin initiation | 
| Use of oxytocin | Pitocin is given as a continuous infusion and the dose is titrated according to the contraction pattern (goal max contractions but not hyperstimulation). We will calculate the total time of Pitocin infusion as well as total dose (rate of infusion x time). | 3 days | 
| Fever over 38 degrees C | Did the patient have a fever over 38 degrees C | within 7 days of Foley placement | 
| Neonatal Intensive Care Unit (NICU) | Was the baby admitted to NICU | within 7 days of Foley placement | 
| APGAR scores | Apgar score is a universal (international) scoring system. The 1-minute score determines how well the baby tolerated the birthing process. The 5-minute score tells the health care provider how well the baby is doing outside the mother's womb. | 1 minute of life | 
| APGAR scores | Apgar score is a universal (international) scoring system. The 1-minute score determines how well the baby tolerated the birthing process. The 5-minute score tells the health care provider how well the baby is doing outside the mother's womb. | 5 minutes of life | 
| Hospital charges | All patients will be charged. We are hoping to see lower charges for women in the Out Patient group. | within 30 days after discharge |