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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Outcome
• Intervention / Treatment: Procedure: Outpatient Foley balloon placement; Procedure: Inpatient Foley Balloon placement

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

• Study Type: Interventional
• Enrollment (Estimated): 412
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18105
      • Recruiting
      • Lehigh Valley Health Network
      • Contact: Joanne N Quinones, MD MSCE; Phone Number: 484-664-7521; Email: joanne_n.quinones@lvhn.org
      • Principal Investigator: Joanne N Quinones, MD MSCE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

• Pregnant women at ≥39 weeks gestation by reliable dating criteria as determined by the American College of Obstetricians and Gynecologists
• Scheduled induction of labor with indication and timing supported by Lehigh Valley Health Network -Labor and Delivery Units (Cedar Crest & Muhlenberg)
• Singleton gestation
• Cephalic presentation
• Amniotic fluid index normal
• Formal prenatal ultrasound during the pregnancy documenting the absence of placenta previa
• Bishop score <6 and cervical dilation <3cm at the time of decision to induce labor
• The woman is able to give appropriate consent and has undergone an informed consent process.
• Maternal age ≥ 18 years old at the time of consent
• English speaking

Exclusion Criteria

• Undergoing outpatient antenatal testing for any medical or obstetric condition
• Need for inpatient observation or continuous fetal monitoring during their cervical ripening
• New diagnosis requiring immediate hospitalization for monitoring (such as new onset hypertensive disease of pregnancy)
• Vaginal bleeding
• Active labor
• Premature rupture of membranes
• Uterine tachysystole (>5 contractions in 10 minutes)
• Non-reassuring fetal heart tracing before Foley placement
• Intrauterine fetal demise diagnosed after enrollment and before placement of balloon
• Contraindication to vaginal delivery, relative or absolute (i.e. transfundal uterine surgery)
• Abnormal placentation including a low lying placenta
• Prior cesarean delivery
• Known fetal major anomaly
• Human immunodeficiency virus, Hepatitis C, or active herpes infection
• Maternal cardiopulmonary disease requiring cardiac monitoring during labor
• Pregestational diabetes or GDMA2
• Rh isoimmunization
• Non-English speaking
• BMI > 40
• Distance from the hospital over 60 minutes by car, unreliable communication via telephone, or unreliable transportation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outpatient cervical ripening; Placement of transcervical Foley balloon for cervical ripening in outpatient setting	Procedure: Outpatient Foley balloon placement; Cervical ripening with balloon placement in the outpatient setting
Active Comparator: Inpatient cervical ripening; Placement of transcervical Foley balloon for cervical ripening in inpatient setting	Procedure: Inpatient Foley Balloon placement; Cervical ripening with balloon placement in the inpatient setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The length of time (measured in minutes) spent on the inpatient unit from admission from cervical ripening and/or labor induction until delivery.	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.	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 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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delivery	Mode of Delivery	12 months
Maternal state	Maternal outcomes	12 months
Neonatal State	Neonatal outcomes	12 months
Maternal Adverse events	Maternal Adverse events such as chorioamnionitis; endometritis; placental abruption; urinary tract infection; preeclampsia,; wound infection; venous thromboembolism; need for post partum antibiotics	12 months
Neonatal adverse events	Neonatal Adverse events such as: hypoglycemia; sepsis; seizures; meconium aspiration; respiratory failure; death	12 months
Birthweight	neonatal birthweight in kilograms	12 months
ICU Length of stay	neonatal ICU length of stay in days	12 months
Total Length of stay	neonatal Inpatient length of stay in days	12 months
Cord PH	Umbilical cord gas PH as reported	12 months
Narcotic dosing	Maternal dosing of narcotic medications before regional anesthesia	12 months
Oxytocin dosing	Oxytocin dose per unit	12 months
Maternal length of stay	Maternal inpatient length of stay in days	12 months

Collaborators and Investigators

• Sponsor: Lehigh Valley Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: cervical Ripening; Labor, induced; Term Birth
• Other Study ID Numbers: 00000949

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No