Cervical Ripening and Induction of Labor, Labor Induction
Conditions
Brief summary
The goal of this clinical trial is to learn if a shorter duration of cervical ripening balloon (CRB) placement can reduce the time to delivery in pregnant women undergoing induction of labor. The main questions it aims to answer are: Does placing the cervical ripening balloon for 3 hours or less result in a shorter interval from insertion to delivery compared to the standard 12-hour placement? Does a shorter 3-hour balloon placement lead to better pregnancy outcomes, fewer complications, and lower maternal discomfort? Researchers will compare a group of participants who have the balloon removed after 3 hours to a control group who have the balloon removed after 12 hours to see if the shorter duration decreases the overall time to delivery. Participants will: Sign an informed consent and be randomized into one of the two groups (3 hours vs. 12 hours). Undergo the standard procedure of a double-lumen Cook cervical ripening balloon insertion. Have the balloon removed after approximately 3 hours or 12 hours depending on their assigned group. Proceed with amniotomy or Pitocin use at the discretion of the labor and delivery physician. Complete a Birth Satisfaction Scale questionnaire and have their maternal and neonatal health outcomes tracked from the hospital's database.
Interventions
DEVICECook Cervical Ripening Balloon 3 hours
Use of a transcervical balloon catheter for pre-induction cervical ripening. The catheter is inserted through the cervix, the balloon(s) inflated with sterile saline. The device remains in place for 3 hours.
DEVICECook Cervical Ripening Balloon 12 hours
Use of a transcervical balloon catheter for pre-induction cervical ripening. The catheter is inserted through the cervix, the balloon(s) inflated with sterile saline. The device remains in place for 12 hours.
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Nulliparous or multiparous pregnant women. * Gestational age between 37 0/7 and 41 6/7 weeks of gestation. * Maternal age between 18 and 45 years. * Participant has provided signed informed consent.
Exclusion criteria
* Presence of any contraindications for vaginal delivery. * Multifetal gestation. * Rupture of membranes prior to balloon insertion. * Favorable cervix, defined as a Bishop score greater than 6. * Cervical dilation greater than 2 cm. * Previous cesarean delivery or any other prior major uterine surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insertion-to-Delivery Time Interval | From the time of balloon insertion up to delivery (approximately 48 hours). | The time interval (in hours) from the successful insertion of the cervical ripening balloon to the time of fetal delivery (whether vaginal or cesarean section). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mode of Delivery | At the time of delivery. | The rates of successful vaginal deliveries, instrumental deliveries (vacuum), and cesarean deliveries between the two groups. |
| Time to Active Phase and Second Stage of Labor | From balloon insertion up to delivery, assessed up to 48 hours after balloon insertion. | The duration (in hours) from balloon insertion to the onset of the active phase of labor, and the duration of the second stage of labor. |
| Maternal Complications | From balloon insertion up to 48 hours postpartum. | Composite rate of maternal complications including chorioamnionitis, postpartum hemorrhage (PPH, defined as estimated blood loss greater than 1000 mL), need for blood transfusion, maternal fever during or after delivery, and obstetric anal sphincter injuries (OASIS). |
| Adverse Neonatal Outcomes | From birth up to newborn discharge or 7 days of life. | Composite rate of neonatal outcomes including birthweight, Apgar scores at 1 and 5 minutes (range 0-10; higher scores indicate better neonatal condition), neonatal umbilical cord pH, rates of respiratory complications, admission to the Neonatal Intensive Care Unit (NICU), and suspected or confirmed neonatal sepsis. |
| Duration of Hospitalization | From admission for induction up to hospital discharge (approximately 3-5 days). | The total length of maternal hospital stay (in days) from the day of admission for labor induction to the day of postpartum discharge. |
Countries
Israel
Outcome results
None listed