NCT05506631

Foley Balloon Study for Cervical Ripening - Cost Comparison Between Outpatient and Inpatient Cervical Ripening

Cost of Inpatient Care for Women Undergoing Outpatient vs. Inpatient Transcervical Balloon Cervical Ripening for Induction of Labor at Term

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Lehigh Valley Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to determine the impact of outpatient cervical ripening with transcervical balloon placement for induction of labor at term on the length and cost of inpatient hospitalization when compared to inpatient cervical ripening.

Detailed description

The objective of the study is to determine the impact of outpatient cervical ripening with transcervical balloon placement for induction of labor at term on the length and cost of inpatient hospitalization when compared to inpatient cervical ripening. Specific Aims In conducting this study, the investigators will accomplish the following specific aim: To compare the length of inpatient care for women undergoing cervical ripening with a transcervical Foley placed in the outpatient vs. inpatient setting prior to induction of labor. * Primary outcomes of interest * The length of time (measured in minutes) spent on the inpatient unit (L\&D) from admission for cervical ripening and/or labor induction until delivery. Outpatient arm: Time for the participants in the outpatient group will be measured from the time the participant is admitted to the hospital for induction of labor until she delivers. Inpatient arm: Time for the participant in the inpatient group will be measured from the time the participant is admitted to the hospital for cervical ripening with balloon placement and induction until she delivers. Time from admission to L\&D until delivery = total INPATIENT until delivery (hours) • Cost Analysis Cost/charges will be calculated for the time spent in the outpatient and inpatient unit for both randomization groups. Cost will be based on information obtained from Enterprise Analytics charges for the time each participant spends in outpatient care, inpatient care, hospitalized from admission to the L\&D unit to delivery. The investigators will report on the delta/difference in average costs of outpatient and inpatient care between the outpatient and inpatient arms of the study. Information will be obtained from the finance department at LVHN. * Secondary outcomes of interest to be compared by randomization groups include: * maternal outcomes * mode of delivery, chorioamnionitis, endometritis, placental abruption, urinary tract infection, preeclampsia, wound infection, venous thromboembolism, maternal treatment with postpartum antibiotics * neonatal outcomes * neonatal birthweight, Apgar scores, admission to the neonatal intensive care unit (ICU), neonatal ICU length of stay, neonatal hypoglycemia, neonatal sepsis, neonatal seizures, meconium aspiration, intubation for respiratory support, neonatal length of stay (total), umbilical cord gas pH, neonatal death or stillbirth * dosing of narcotic medications before regional anesthesia * total oxytocin infusion dosing * total length of stay for mothers and neonates

Conditions

• Pregnancy Outcome

Interventions

Type	Name	Description
PROCEDURE	Outpatient Foley balloon placement	Cervical ripening with balloon placement in the outpatient setting
PROCEDURE	Inpatient Foley Balloon placement	Cervical ripening with balloon placement in the inpatient setting

Timeline

• Start date: 2021-11-01
• Primary completion: 2024-05-30
• Completion: 2024-10-30
• First posted: 2022-08-18
• Last updated: 2025-05-31

Locations

1 site across 1 country: United States