Clinical trial NCT05922111: Cervical Ripening Balloon for 12 Hours vs. 1 Hour.
Official title: Comparison of Labor Induction With Cervical Ripening Balloon, One Versus Tweleve Hours Placement: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Induction of Labor
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be an open-label,1:1, randomized controlled trial.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. Nulliparous or multiparous gravidas
2. Gestational age ≥ 370/7 to 416/7 gestational weeks
3. Age 18-45
4. Signed informed consent

Exclusion Criteria:

1. Contraindications for vaginal delivery
2. Multifetal gestation
3. Rupture of membranes
4. Bishop score \> 6
5. The cervix is dilated to more than 2 cm
6. Previous caesarean delivery

Primary outcomes:
measure: insertion to delivery time interval
timeFrame: From date of balloon insertion until the date of delivery, assessed up to 4 days
Secondary outcomes:
measure: to compare the mode of delivery
timeFrame: From date of balloon insertion until the date of delivery, assessed up to 4 days
measure: to compare the time to active and second stage of labor
timeFrame: From date of balloon insertion until the date of delivery, assessed up to 4 days
measure: to compare the rate of chorioamnionitis
timeFrame: From date of balloon insertion until the date of discharge, assessed up to 8 days
measure: to compare the rate of post-partum hemorrhage
timeFrame: From date of balloon insertion until the date of discharge, assessed up to 8 days
measure: to compare the need for blood transfusion
timeFrame: From date of balloon insertion until the date of discharge, assessed up to 8 days
measure: to compare the rate of anal sphincter injuries
timeFrame: From date of balloon insertion until the date of discharge, assessed up to 8 days
measure: To compare the length of maternal hospital stay
timeFrame: From date of balloon insertion until the date of discharge, assessed up to 8 days
measure: To compare the overall satisfaction rate
timeFrame: From date of balloon insertion until the date of discharge, assessed up to 8 days
measure: To compare the Apgar score between the groups
timeFrame: at the date of delivery
measure: To compare the rate of neonatal acidemia between the groups
timeFrame: From date of delivery until the date of neonate discharge, assessed up to 14 days
measure: To compare the rate of admission to neonatal intensive care unit between the groups
timeFrame: From date of delivery until the date of neonate discharge, assessed up to 14 days
measure: To compare the rate of Respiratory complications between the groups
timeFrame: From date of delivery until the date of neonate discharge, assessed up to 14 days
measure: To compare the rate of neonatal sepsis between the groups
timeFrame: From date of delivery until the date of neonate discharge, assessed up to 14 days
measure: To compare the rate of birthweightbetween the groups
timeFrame: at the date of delivery
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Naphtali Justman
role: PRINCIPAL_INVESTIGATOR
References: