Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
The goal of this clinical trial is to learn if a shorter duration of cervical ripeningballoon (CRB) placement can reduce the time to delivery in pregnant women undergoinginduction of labor.The main questions it aims to answer are:Does placing the cervical ripening balloon for 3 hours or less result in a shorterinterval from insertion to delivery compared to the standard 12‐hour placement?Does a shorter 3‐hour balloon placement lead to better pregnancy outcomes, fewercomplications, and lower maternal discomfort?Researchers will compare a group of participants who have the balloon removed after 3hours to a control group who have the balloon removed after 12 hours to see if theshorter duration decreases the overall time to delivery.Participants will:Sign an informed consent and be randomized into one of the two groups (3 hours vs. 12hours).Undergo the standard procedure of a double‐lumen Cook cervical ripening ballooninsertion.Have the balloon removed after approximately 3 hours or 12 hours depending on theirassigned group.Proceed with amniotomy or Pitocin use at the discretion of the labor and deliveryphysician.Complete a Birth Satisfaction Scale questionnaire and have their maternal and neonatalhealth outcomes tracked from the hospital's database.
Epistemonikos ID: 6093602b21128f884040cb3b071e3a01a8d7a158
First added on: Jul 09, 2026