Combined Nipple Stimulation and Foley Balloon for Cervical Ripening

NCT07317674 | Not Yet Recruiting

• 1 other identifier: NHR-0186-25
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Induction of Labor; Cervical Ripening

Outcome Measures

Primary Outcomes (2)

• Induction-to-delivery interval

  Defined as the time (in hours) from Foley balloon catheter insertion until delivery.

  From Foley balloon catheter insertion until delivery (up to 48 hours)

• Change in Bishop score

  Defined as the difference between the Bishop score before Foley balloon catheter insertion and after catheter removal.

  From Foley balloon catheter insertion until catheter removal (up to 12 hours)

Study Arms (2)

Foley Balloon Catheter Combined With Nipple Stimulation

EXPERIMENTAL

Participants in this arm will undergo cervical ripening using a single-balloon Foley catheter. One hour after catheter insertion, nipple stimulation will be initiated using a breast pump according to a standardized protocol (15 minutes per breast, alternating with 15-minute rest periods, for up to 6 hours or until active labor, membrane rupture, uterine tachysystole, or non-reassuring fetal heart rate occurs).

Procedure: Foley balloon catheter with nipple stimulation

Foley Balloon Catheter Alone

ACTIVE COMPARATOR

Participants in this arm will undergo cervical ripening using a single-balloon Foley catheter alone, without nipple stimulation. Labor management following catheter insertion and removal will follow standard institutional protocols.

Procedure: Mechanical cervical ripening with Foley catheter

Interventions

Foley balloon catheter with nipple stimulation PROCEDURE

Mechanical 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

Foley Balloon Catheter Combined With Nipple Stimulation

Mechanical cervical ripening with Foley catheter PROCEDURE

Mechanical 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.

Foley Balloon Catheter Alone

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is open to individuals who self-identify as female and are pregnant.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant individuals aged ≥18 years
• Singleton pregnancy
• Term gestation (37-42 weeks)
• Cephalic fetal presentation
• Intact membranes
• Bishop score \<6 at enrollment
• Medical indication for labor induction

You may not qualify if:

• Multiple gestation
• Previous cesarean delivery or uterine surgery
• Contraindication to vaginal delivery
• Major fetal anomalies
• Active labor at enrollment
• Unstable fetal lie or presentation
• Contraindication to Foley balloon catheter insertion
• Conditions precluding nipple stimulation (e.g., local breast infection, prior breast surgery involving the nipple)

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Related Publications (3)

• Kavanagh J, Kelly AJ, Thomas J. Breast stimulation for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD003392. doi: 10.1002/14651858.CD003392.pub2.

  PMID: 16034897 RESULT

• Abu Shqara R, Goldinfeld G, Assulyn T, Sgayer I, Ganem N, Lowenstein L, Frank Wolf M. Breast stimulation vs low dose oxytocin for labor augmentation in women with a previous cesarean delivery, a randomized controlled trial. Am J Obstet Gynecol MFM. 2025 May;7(5):101658. doi: 10.1016/j.ajogmf.2025.101658. Epub 2025 Mar 5.

  PMID: 40054666 RESULT

• de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2019 Oct 18;10(10):CD001233. doi: 10.1002/14651858.CD001233.pub3.

  PMID: 31623014 RESULT

Study Officials

• Maya Frank Wolf, Prof.

  Galilee Medical Center

  STUDY CHAIR

Central Study Contacts

Maya Frank Wolf Frank Wolf, Prof.

CONTACT

+9729107723; mayaw@gmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of MFMU

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share