Clinical trial NCT05798728: Outpatient Transcervical Balloon For Induction of Labor
Official title: Outpatient Transcervical Balloon: Does it Shorten the Hospital Stay for Induction of Labor? Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Induced Vaginal Delivery
Induced; Birth
Keywords: Misoprostol
Cytotec
Cervical ripening
Outpatient
Inpatient
Transcervical foley balloon
Mechanical dilation
Lead sponsor: Hurley Medical Center
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized control trial is to compare outpatient transcervical foley balloon to inpatient vaginal misoprostol in pregnant women for cervical ripening. The main questions it aims to answer are:

1. Does outpatient transcervical foley balloon decreased the time from admission to delivery compared to inpatient vaginal misoprostol
2. Does outpatient transcervical foley balloon will increase risk of c-section during induction of labor compared to inpatient vaginal misoprostol

Participants will be randomized to either the outpatient transcervical foley balloon group or to the inpatient intravaginal misoprostol group. The researchers will compare if outpatient transcervical foley balloon decreases the tie from hospital admission to delivery of the baby.

Detailed description: This is a prospective randomized unblinded control trial. Consented patients will have a cervical exam performed in the clinic to confirm that the bishop score is less than 6. Once this and the inclusion criteria are met, the participant will be randomized to either the outpatient transcervical foley arm or the vaginal misoprostol arm. Each pregnant woman will undergo the intervention stated in the numbered envelope which will be distributed based on their order of inclusion in the study. Due to the nature of the procedure, blinding could not be done.

Participants randomized to the transcervical foley group will be scheduled an appointment in the clinic the day before their scheduled induction day for the final screen and foley placement. On the other hand, participants randomized to the vaginal misoprostol group will be admitted to the labor and delivery unit on the day of their scheduled induction. All participants will undergo a cervical examination before the assigned intervention to verify their eligibility status. Those who do not meet the eligibility criteria, will be excluded. Both transcervical foley and vaginal misoprostol are standard of care for induction of labor at Hurley Medical Center. Thus, there would be no additional cost to the patient. The only difference in the study is the setting in which the transcervical foley is placed, i.e. in the obstetrics clinic as an outpatient.

Oxytocin will be initiated in all patients who did not have at least three regular contractions in 10 minutes. Continuous fetal heart rate monitoring and uterine activity monitoring will be performed in all patients. Amniotomy will be performed during the course of labor at the discretion of the health care provider and epidural anesthesia will be administered per the patient's request.

Eligibility criteria: Inclusion Criteria:

1. Term singleton pregnancy (37 weeks of gestation or greater)
2. Bishop score less than 6 and a maximum cervical dilation of 2 cm
3. Cephalic presentation

Exclusion Criteria:

1. Rupture of membranes
2. Regular uterine contractions (3 or more contractions per 10 minutes)
3. History of prior uterine surgery (cesarean delivery or myomectomy)
4. Multiples gestations
5. Malpresentation
6. Nonreassuring fetal heart tracing (category 3 or persistent category 2)
7. Fetal demise
8. Anomalous fetus
9. Any contraindication to vaginal delivery

Primary outcomes:
measure: Time from hospital admission to delivery of the newborn
timeFrame: From hospital admission until delivery of the newborn
Secondary outcomes:
measure: Chorioamnionitis/endometritis
timeFrame: From hospital admission until 2 weeks postpartum
measure: Cesarean delivery
timeFrame: From hospital admission until delivery of the newborn
measure: Postpartum hemorrhage
timeFrame: From hospital admission until 2 weeks postpartum
measure: Delivery within 24 hours of hospital admission
timeFrame: From hospital admission until delivery of the newborn
measure: Total hospital length of stay
timeFrame: From hospital admission until discharge, assessed up to a week
measure: Hospital readmission within 30 days of discharge
timeFrame: From discharge until 30 days postpartum
measure: Cervical examination at the time of admission
timeFrame: Within the first hour of hospital admission
measure: Unscheduled hospital admissions or unscheduled visits to our obstetric triage unit before the time of scheduled admission
timeFrame: From date of outpatient transcervical foley balloon placement until time of scheduled admission, assessed up to 12 hours
measure: Frequency of acetaminophen use after randomization but before hospital admission
timeFrame: From time of outpatient transcervical foley balloon placement until hospital admission, assessed up to 12 hours
measure: Spontaneous rupture of membranes between randomization and hospital admission
timeFrame: From time of transcervical foley balloon placement until spontaneous rupture of membranes, assessed up to 12 hours
measure: Duration of oxytocin infusion (in min)
timeFrame: From hospital admission until delivery of the newborn
measure: Maximum oxytocin rate infused (in milliunits/min)
timeFrame: From hospital admission until delivery of the newborn
measure: Duration of neuraxial anesthesia use
timeFrame: From hospital admission until delivery of the newborn
measure: Presence of heavy vaginal bleeding before delivery
timeFrame: From outpatient transcervical foley balloon insertion until delivery of newborn
measure: Meconium-stained amniotic fluid
timeFrame: From hospital admission until delivery of the newborn
measure: Time from rupture of membranes to delivery
timeFrame: From time of rupture of membranes until delivery of the newborn
measure: Highest maternal intrapartum temperature
timeFrame: From hospital admission until delivery of the newborn
measure: Admission white blood cell count
timeFrame: From hospital admission until delivery of the newborn
Other outcomes:
Locations:
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
Study officials:
affiliation: Hurley Medical Canter
name: Atinuke Akinpeloye, MD
role: PRINCIPAL_INVESTIGATOR
References: