Combined Nipple Stimulation and Foley Balloon for Cervical Ripening
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWestern Galilee Hospital-Nahariya
About this trial
Labor induction rates have increased substantially worldwide, and successful cervical ripening remains a key determinant of induction outcomes. Mechanical cervical ripening with a Foley balloon catheter is widely used and considered safe, while nipple stimulation promotes endogenous oxytocin release and represents a physiologic method for stimulating uterine contractions. However, the combined effect of nipple stimulation and balloon catheter use has not been systematically evaluated.
This prospective, randomized, double-blinded controlled trial will assess whether the addition of nipple stimulation to Foley balloon catheter cervical ripening improves Bishop score and shortens the induction-to-delivery interval compared with balloon catheter alone. Term pregnant patients (37-42 weeks' gestation) with a singleton, cephalic pregnancy and an unfavorable cervix (Bishop score \<6) requiring labor induction will be randomized to receive either Foley balloon catheter plus standardized nipple stimulation or Foley balloon catheter alone.
The primary outcomes are change in Bishop score after catheter removal and time from catheter insertion to delivery. Secondary outcomes include need for additional induction methods, mode of delivery, maternal and neonatal outcomes, pain, patient satisfaction, and breastfeeding rates. The study aims to evaluate the efficacy and safety of incorporating a physiologic intervention into standard mechanical cervical ripening.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant individuals aged ≥18 years
Singleton pregnancy
Term gestation (37-42 weeks)
Cephalic fetal presentation
Disqualifiers
Multiple gestation
Previous cesarean delivery or uterine surgery
Contraindication to vaginal delivery
Major fetal anomalies
Trial design
Design model
Parallel
Treatments tested in this trial
Foley balloon catheter with nipple stimulation
Procedure/SurgeryMechanical cervical ripening will be performed using a single-balloon Foley catheter inserted transcervically under sterile conditions. The catheter balloon will be positioned above the internal cervical os and inflated with 60 mL of sterile saline solution. The catheter will remain in place for up to 12 hours or until spontaneous expulsion, onset of active labor, rupture of membranes, uterine tachysystole, or non-reassuring fetal heart rate tracing, whichever occurs first. In participants randomized to the intervention arm, cervical ripening with the Foley catheter will be combined with nipple stimulation using an electric breast pump according to a standardized protocol, beginning one hour after catheter insertion. Participants in the control arm will undergo cervical ripening with the Foley catheter alone, without nipple stimulation. Cervical status will be assessed before catheter insertion and after catheter removal using the Bishop score. Subsequent labor management will follow
Mechanical cervical ripening with Foley catheter
Procedure/SurgeryMechanical cervical ripening will be performed using a single-balloon Foley catheter inserted transcervically under sterile conditions. The catheter balloon will be positioned above the internal cervical os and inflated with 60 mL of sterile saline solution. The catheter will remain in place for up to 12 hours or until spontaneous expulsion, onset of active labor, rupture of membranes, uterine tachysystole, or non-reassuring fetal heart rate tracing, whichever occurs first.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Foley Balloon Catheter Combined With Nipple StimulationExperimental treatment 1 intervention
Group B: Foley Balloon Catheter AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Induction-to-delivery interval
Defined as the time (in hours) from Foley balloon catheter insertion until delivery.
Time frame
From Foley balloon catheter insertion until delivery (up to 48 hours)2
Change in Bishop score
Defined as the difference between the Bishop score before Foley balloon catheter insertion and after catheter removal.
Time frame
From Foley balloon catheter insertion until catheter removal (up to 12 hours)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: