Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 hours balloon group | Experimental | Double-balloon cervical ripening catheter inserted and left in place for 3 hours before removal |
|
| 12 hours balloon group | Active Comparator | Double-balloon cervical ripening catheter inserted and left in place for 12 hours before removal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cook Cervical Ripening Balloon 3 hours | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Insertion-to-Delivery Time Interval | 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). | From the time of balloon insertion up to delivery (approximately 48 hours). |
| Measure | Description | Time Frame |
|---|---|---|
| Mode of Delivery | The rates of successful vaginal deliveries, instrumental deliveries (vacuum), and cesarean deliveries between the two groups. | At the time of delivery. |
| Time to Active Phase and Second Stage of Labor |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Eligibility is based strictly on biological sex (pregnant individuals with an unfavorable cervix requiring labor induction)
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus | Recruiting | Haifa | 31906 | Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cook Cervical Ripening Balloon 12 hours | Device | 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. |
|
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.
| From balloon insertion up to delivery, assessed up to 48 hours after balloon insertion. |
| Maternal Complications | 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). | From balloon insertion up to 48 hours postpartum. |
| Adverse Neonatal Outcomes | 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. | From birth up to newborn discharge or 7 days of life. |
| Duration of Hospitalization | The total length of maternal hospital stay (in days) from the day of admission for labor induction to the day of postpartum discharge. | From admission for induction up to hospital discharge (approximately 3-5 days). |