Inpatient Versus Outpatient Foley Cervical Ripening Study

Not Applicable

Completed

• Conditions: Induced; Birth
• Interventions: Behavioral: Inpatient; Behavioral: Outpatient

• Registration Number: NCT03725397
• Lead Sponsor: Yale University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-06-22
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-31
• Study Start: 2019-01-08
• Primary Completion: 2022-06-27
• Study Completion: 2022-06-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inpatients with a transcervical Foley catheter	Inpatient	Women to be admitted to the hospital overnight which has been a "standard of care".
Outpatients with a transcervical Foley catheter	Outpatient	Women with a transcervical Foley catheter in place that will spend the night at home.

Primary Outcome Measures

Name	Time	Method
Time of Foley catheter extrusion	within 24 hours	Antepartum time of Foley catheter extrusion before patient being brought to labor

Secondary Outcome Measures

Name	Time	Method
Use of oxytocin	3 days	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).
Neonatal Intensive Care Unit (NICU)	within 7 days of Foley placement	Was the baby admitted to NICU
Total time slept during pre-induction	during labor	Total time slept during pre-induction
Analgesia used during pre-induction	within 24 hours before Pitocin initiation	Analgesia used during pre-induction
Bishop score	during labor	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
Fever over 38 degrees C	within 7 days of Foley placement	Did the patient have a fever over 38 degrees C
Total time in cervical ripening	from labor induction to delivery time	Measure of total time in cervical ripening
Total time in hospital	no max but an average of 3 days	Total time in hospital
APGAR scores	5 minutes of life	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.
Hospital charges	within 30 days after discharge	All patients will be charged. We are hoping to see lower charges for women in the Out Patient group.

Trial Locations

Locations (2)

Yale New Haven Hospital- St. Raphael; 🇺🇸 New Haven, Connecticut, United States

Yale New Haven Hospital, York Street Campus; 🇺🇸 New Haven, Connecticut, United States