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

Lehigh Valley Hospital

Status

Enrolling

Conditions

Pregnancy Outcome

Treatments

Procedure: Outpatient Foley balloon placement

Procedure: Inpatient Foley Balloon placement

Study type

Interventional

Funder types

Other

Identifiers

NCT05506631

00000949

Details and patient eligibility

About

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.

Full 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

Enrollment

412 estimated patients

Sex

Female

Ages

18 to 39 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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