Cervical Ripening Balloon for 12 Hours vs. 1 Hour.

Rambam Health Care Campus

Status: Not yet enrolling

Conditions: Induction of Labor

Treatments: Device: cervical ripening balloon for one hour; Device: cervical ripening balloon for twelve hours

Study type: Interventional

Funder types: Other

Identifiers

NCT05922111

0602-21-RMB CTIL

Details and patient eligibility

About

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.

Full 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

Enrollment: 164 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

cervical ripening balloon for 1 hour

Experimental group

Description:

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 thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician

Treatment:

Device: cervical ripening balloon for one hour

cervical ripening balloon for 12 hours

Active Comparator group

Description:

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 12 hours in the control group and thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician

Treatment:

Device: cervical ripening balloon for twelve hours