The aim of this study is a comparison of induction of labor with a cervical ripening balloon left in place for one hour compared to twelve hours. The primary outcome is time to delivery. Women admitted for induction of labor will be recruited and randomized to either a cervical ripening balloon for one hour or twelve hours. the management of delivery after the extraction of the balloon will be left to the discretion of the attending physician.
The common IOL techniques used for pregnant women with unfavorable cervix might be specified to either mechanical induction via cervical ripening balloon (CRB) or pharmacological induction. The insertion of a CRB is believed to mechanically ripen the uterine cervix with a better safety profile than prostaglandins. The duration of the balloon placement varied considerably, and it was commonly placed for 12-24 hours. Nevertheless, recent randomized controlled studies have demonstrated favorable results following only 6 hours of CRB placement with or without additional administration of oxytocin. We believe that mechanical ripening of the cervix can be achieved even less than six hours. Our study aims to evaluate the time to delivery and pregnancy outcomes after placement of CRB of only 1 hour compared to either 6 or 12 hours. Study Protocol: 1. Women planned for induction of labor will be approached by a trained resident and will sign informed consent. 2. All participants will be randomized to either one hour or twelve hours CRB placement using a computer program randomization scheme, block size of 20, by the department research coordinator who will keep the sequential in sealed envelopes. 3. Demographic parameters will be retrieved from the computerized database of Rambam Medical Center (RMC). 4. Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after an hour in the intervention group and after twelve hours in the control group. Thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
The cervical ripening balloon will be left in place for one hour and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room
The cervical ripening balloon will be left in place for for twelve hours and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room
insertion to delivery time interval
The time interval between balloon insertion to delivery
Time frame: From date of balloon insertion until the date of delivery, assessed up to 4 days
to compare the mode of delivery
Mode of delivery
Time frame: From date of balloon insertion until the date of delivery, assessed up to 4 days
to compare the time to active and second stage of labor
Time to active and second stage of labor
Time frame: From date of balloon insertion until the date of delivery, assessed up to 4 days
to compare the rate of chorioamnionitis
Rate of chorioamnionitis
Time frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
to compare the rate of post-partum hemorrhage
Rate of post-partum hemorrhage and need for blood transfusion
Time frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
to compare the need for blood transfusion
the need for blood transfusion
Time frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
to compare the rate of anal sphincter injuries
Rate of obstetric anal sphincter injuries
Time frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
To compare the length of maternal hospital stay
Length of maternal hospital stay
Time frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
To compare the overall satisfaction rate
Overall satisfaction using the Birth satisfaction scale questionnaire with higher score means a better outcome. minimal score 30, maximal score 150.
Time frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
To compare the Apgar score between the groups
Apgar score - higher score means better outcome. Minimal score is 0, maximal Apgar score is 10.
Time frame: at the date of delivery
To compare the rate of neonatal acidemia between the groups
Neonatal acidemia
Time frame: From date of delivery until the date of neonate discharge, assessed up to 14 days
To compare the rate of admission to neonatal intensive care unit between the groups
Admission to neonatal intensive care unit
Time frame: From date of delivery until the date of neonate discharge, assessed up to 14 days
To compare the rate of Respiratory complications between the groups
Respiratory complications
Time frame: From date of delivery until the date of neonate discharge, assessed up to 14 days
To compare the rate of neonatal sepsis between the groups
Neonatal sepsis
Time frame: From date of delivery until the date of neonate discharge, assessed up to 14 days
To compare the rate of birthweightbetween the groups
Birthweight in grams
Time frame: at the date of delivery