Cervical Ripening Balloon for 12 Hours vs. 1 Hour.

Induction of Labor Clinical Trial

Official title:

Comparison of Labor Induction With Cervical Ripening Balloon, One Versus Tweleve Hours Placement: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05922111
• Other study ID #: 0602-21-RMB CTIL
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2023
• Source: Rambam Health Care Campus
• Contact: Naphtali Justman
• Phone: 0546836644
• Email: njustman88[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 164
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Induction of Labor

Intervention

Device:
• cervical ripening balloon for one hour
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
• cervical ripening balloon for twelve hours
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insertion to delivery time interval	The time interval between balloon insertion to delivery	From date of balloon insertion until the date of delivery, assessed up to 4 days
Secondary	to compare the mode of delivery	Mode of delivery	From date of balloon insertion until the date of delivery, assessed up to 4 days
Secondary	to compare the time to active and second stage of labor	Time to active and second stage of labor	From date of balloon insertion until the date of delivery, assessed up to 4 days
Secondary	to compare the rate of chorioamnionitis	Rate of chorioamnionitis	From date of balloon insertion until the date of discharge, assessed up to 8 days
Secondary	to compare the rate of post-partum hemorrhage	Rate of post-partum hemorrhage and need for blood transfusion	From date of balloon insertion until the date of discharge, assessed up to 8 days
Secondary	to compare the need for blood transfusion	the need for blood transfusion	From date of balloon insertion until the date of discharge, assessed up to 8 days
Secondary	to compare the rate of anal sphincter injuries	Rate of obstetric anal sphincter injuries	From date of balloon insertion until the date of discharge, assessed up to 8 days
Secondary	To compare the length of maternal hospital stay	Length of maternal hospital stay	From date of balloon insertion until the date of discharge, assessed up to 8 days
Secondary	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.	From date of balloon insertion until the date of discharge, assessed up to 8 days
Secondary	To compare the Apgar score between the groups	Apgar score - higher score means better outcome. Minimal score is 0, maximal Apgar score is 10.	at the date of delivery
Secondary	To compare the rate of neonatal acidemia between the groups	Neonatal acidemia	From date of delivery until the date of neonate discharge, assessed up to 14 days
Secondary	To compare the rate of admission to neonatal intensive care unit between the groups	Admission to neonatal intensive care unit	From date of delivery until the date of neonate discharge, assessed up to 14 days
Secondary	To compare the rate of Respiratory complications between the groups	Respiratory complications	From date of delivery until the date of neonate discharge, assessed up to 14 days
Secondary	To compare the rate of neonatal sepsis between the groups	Neonatal sepsis	From date of delivery until the date of neonate discharge, assessed up to 14 days
Secondary	To compare the rate of birthweightbetween the groups	Birthweight in grams	at the date of delivery