Clinical trial NCT05506631: Foley Balloon Study for Cervical Ripening - Cost Comparison Between Outpatient and Inpatient Cervical Ripening
Official title: Cost of Inpatient Care for Women Undergoing Outpatient vs. Inpatient Transcervical Balloon Cervical Ripening for Induction of Labor at Term
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Outcome
Keywords: cervical Ripening
Labor, induced
Term Birth
Lead sponsor: Lehigh Valley Hospital
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: The length of time (measured in minutes) spent on the inpatient unit from admission from cervical ripening and/or labor induction until delivery.
timeFrame: 12 months
measure: Cost Analysis in dollars Cost/charges will be calculated for the time spent in the outpatient and inpatient unit for both randomization groups.
timeFrame: 12 months
Secondary outcomes:
measure: Delivery
timeFrame: 12 months
measure: Maternal state
timeFrame: 12 months
measure: Neonatal State
timeFrame: 12 months
measure: Maternal Adverse events
timeFrame: 12 months
measure: Neonatal adverse events
timeFrame: 12 months
measure: Birthweight
timeFrame: 12 months
measure: ICU Length of stay
timeFrame: 12 months
measure: Total Length of stay
timeFrame: 12 months
measure: Cord PH
timeFrame: 12 months
measure: Narcotic dosing
timeFrame: 12 months
measure: Oxytocin dosing
timeFrame: 12 months
measure: Maternal length of stay
timeFrame: 12 months
Other outcomes:
Locations:
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
Study officials:
References: