Foley Balloon Study for Cervical Ripening - Cost Comparison Between Outpatient and Inpatient Cervical Ripening
- Conditions
- Pregnancy Outcome
- Interventions
- Procedure: Inpatient Foley Balloon placementProcedure: Outpatient Foley balloon placement
- Registration Number
- NCT05506631
- Lead Sponsor
- Lehigh Valley Hospital
- Brief 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 412
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inpatient cervical ripening Inpatient Foley Balloon placement Placement of transcervical Foley balloon for cervical ripening in inpatient setting Outpatient cervical ripening Outpatient Foley balloon placement Placement of transcervical Foley balloon for cervical ripening in outpatient setting
- Primary Outcome Measures
Name Time Method Cost Analysis in dollars Cost/charges will be calculated for the time spent in the outpatient and inpatient unit for both randomization groups. 12 months Cost Analysis in dollars
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 woman spends in outpatient care, inpatient care, hospitalized from admission to the L\&D unit to delivery.The length of time (measured in minutes) spent on the inpatient unit from admission from cervical ripening and/or labor induction until delivery. 12 months 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.
- Secondary Outcome Measures
Name Time Method Oxytocin dosing 12 months Oxytocin dose per unit
Delivery 12 months Mode of Delivery
Neonatal adverse events 12 months Neonatal Adverse events such as: hypoglycemia; sepsis; seizures; meconium aspiration; respiratory failure; death
Maternal state 12 months Maternal outcomes
Neonatal State 12 months Neonatal outcomes
ICU Length of stay 12 months neonatal ICU length of stay in days
Total Length of stay 12 months neonatal Inpatient length of stay in days
Cord PH 12 months Umbilical cord gas PH as reported
Narcotic dosing 12 months Maternal dosing of narcotic medications before regional anesthesia
Maternal Adverse events 12 months Maternal Adverse events such as chorioamnionitis; endometritis; placental abruption; urinary tract infection; preeclampsia,; wound infection; venous thromboembolism; need for post partum antibiotics
Birthweight 12 months neonatal birthweight in kilograms
Maternal length of stay 12 months Maternal inpatient length of stay in days
Trial Locations
- Locations (1)
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States