Cervical Ripening Balloon for 12 Hours vs. 1 Hour.

Launched by RAMBAM HEALTH CARE CAMPUS · Jun 18, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how long a special device called a cervical ripening balloon should be left in place to help women prepare for labor. The researchers want to compare the effects of leaving the balloon in for one hour versus twelve hours to see which option leads to a quicker delivery. Women who are getting ready to give birth and are admitted for labor induction may have the chance to participate in this study.

To be eligible, participants should be between the ages of 18 and 45 and at least 37 weeks pregnant. They can be first-time mothers or have had children before. However, women with certain conditions, like those who cannot have a vaginal delivery or are expecting multiple babies, will not be included. If you decide to join the trial, after the balloon is removed, the doctors will decide how to manage the delivery based on their professional judgment. This study is not yet recruiting, but it's an opportunity to contribute to important research on labor induction.

Gender

FEMALE

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