Heated Saline in Cervical Balloon for Labor Induction, a RCT (NCT05864326) | Clinical Trial Compass
CompletedNot Applicable
Heated Saline in Cervical Balloon for Labor Induction, a RCT
Switzerland290 participantsStarted 2023-10-16
Plain-language summary
This study is a single-center, randomized, two-arm, controlled trial, including women requiring cervical ripening during the process Induction of Labor using Balloon catheter (BC). The primary objective of the study is to determine if the use of heated saline in the BC used for cervical ripening reduces the length of BC duration.
Participants will be allocated to :
* Intervention or warm group: the BC will be filled with heated saline water up to 40° C
* Standard or room temperature group: the BC will be filled with saline water at room temperature.
Who can participate
Age range
16 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Gestational age at or over 35 weeks
* Singleton pregnancy
* Alive fetus
* Cephalic presentation
* Maternal age ≥ 16 years
Exclusion Criteria:
* Active labor (dilated cervix with spontaneous uterine contractions)
* Prelabor rupture of membranes
* \>1 Previous cesarean delivery
* Fetal malformation leading to a possible obstruction of labor (e.g., hydrocephaly, exteriorized fetal tumors, etc.)
* Maternal or fetal disease with indication to accelerate labor (start oxytocin stimulation within 6 hours after insertion of the BC (e.g., pre-eclampsia, chorioamnionitis, etc.)\]
* Counterindication to vaginal delivery
* Impossibility to give consent to participation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine if the use of heated saline in the Balloon Catheter (BC), used for cervical ripening, reduces the length of BC duration, defined as the time from the insertion to spontaneous expulsion or artificial removal of the BC.
Timeframe: Through study completion, an average of 1.5 years