Induction of LaborNCT07317674
Combined Nipple Stimulation and Foley Balloon for Cervical Ripening
A study testing Foley balloon catheter with nipple stimulation and Mechanical cervical ripening with Foley catheter in people with Induction of Labor and Cervical Ripening, run by Western Galilee Hospital-Nahariya.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor, Cervical Ripening
- What is being tested?
- Foley balloon catheter with nipple stimulation and Mechanical cervical ripening with Foley catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Nipple Stimulation Combined With Foley Balloon Catheter on Bishop Score and Induction-to-delivery Interval: a Prospective Randomized 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.
Read the detailed description
Rates of labor induction have increased substantially in recent decades in Israel and worldwide. Cervical ripening is a critical component of successful labor induction, and an unfavorable cervix, as reflected by a low Bishop score, is associated with prolonged induction, increased need for additional interventions, and higher rates of operative delivery. Mechanical methods, particularly the Foley balloon catheter, are commonly used for cervical ripening due to their effectiveness and favorable safety profile, including a lower risk of uterine tachysystole compared with pharmacologic agents.
Nipple stimulation is a non-pharmacologic, physiologic method that promotes endogenous oxytocin release and uterine contractions, mimicking spontaneous labor. Prior studies have suggested that nipple stimulation may reduce the need for exogenous oxytocin and lower the incidence of uterine hyperstimulation, while achieving comparable maternal and neonatal outcomes. However, the combined use of nipple stimulation with mechanical cervical ripening has not been systematically evaluated.
This study is a prospective, randomized, double-blinded controlled trial designed to evaluate whether the addition of nipple stimulation to Foley balloon catheter cervical ripening improves cervical readiness and shortens the induction-to-delivery interval compared with Foley balloon catheter alone. Eligible participants are term pregnant patients (37-42 weeks' gestation) with singleton, cephalic pregnancies, intact membranes, and an unfavorable cervix (Bishop score <6) who require labor induction for standard obstetric indications.
Participants will be randomized in a 1:1 ratio to one of two study groups. The intervention group will undergo cervical ripening with a Foley balloon catheter in combination with a standardized nipple stimulation protocol using a breast pump. Nipple stimulation will begin one hour after catheter insertion and will consist of alternating stimulation of each breast for 15 minutes with 15-minute rest intervals, for up to six hours, at the maximum tolerable intensity. The control group will receive cervical ripening with a Foley balloon catheter alone, with standard obstetric management.
Fetal heart rate monitoring will be performed at regular intervals according to institutional protocols, with increased monitoring as clinically indicated. The balloon catheter will be removed after 12 hours, earlier if spontaneous labor ensues, membranes rupture, uterine tachysystole occurs, or non-reassuring fetal status is suspected.
Primary outcomes include the change in Bishop score following catheter removal and the induction-to-delivery interval. Secondary outcomes include the need for additional induction methods (e.g., oxytocin or prostaglandins), time to active labor, mode of delivery, maternal complications (including intrapartum fever, chorioamnionitis, postpartum hemorrhage, and uterine tachysystole), neonatal outcomes (Apgar scores, umbilical cord pH, NICU admission), maternal pain and satisfaction scores, and breastfeeding rates.
The findings of this study will provide evidence regarding the efficacy and safety of integrating a physiologic intervention with mechanical cervical ripening and may inform future strategies to optimize labor induction while minimizing pharmacologic exposure.
- Conditions
- Induction of Labor, Cervical Ripening
- Being tested
- Foley balloon catheter with nipple stimulation, Mechanical cervical ripening with Foley catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley balloon catheter with nipple stimulationProcedure or surgery
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
Mechanical cervical ripening with Foley catheterProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: Mechanical cervical ripening with Foley catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction-to-delivery interval
Defined as the time (in hours) from Foley balloon catheter insertion until delivery.
Measured: 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.
Measured: From Foley balloon catheter insertion until catheter removal (up to 12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Induction of LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Raneen Abu Shqara, Western Galilee Hospital-Nahariya
- Investigators
- Maya Frank Wolf, Prof., Study chair, Galilee Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317674
- Sponsor's protocol ID
- NHR-0186-25
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. De-identified aggregate data may be presented in scientific publications and presentations in accordance with institutional policies and ethical approvals.
Publications
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.
PubMed 16034897Abu 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.
PubMed 40054666de 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.
PubMed 31623014
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nipple Stimulation Combined With Foley Balloon Catheter on Bishop Score and Induction-to-delivery Interval: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07317674
- Acronym / sponsor ID
- NHR-0186-25
- Conditions
- Induction of Labor, Cervical Ripening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rates of labor induction have increased substantially in recent decades in Israel and worldwide. Cervical ripening is a critical component of successful labor induction, and an unfavorable cervix, as reflected by a low Bishop score, is associated with prolonged induction, increased need for additional interventions, and higher rates of operative delivery. Mechanical methods, particularly the Foley balloon catheter, are commonly used for cervical ripening due to their effectiveness and favorable safety profile, including a lower risk of uterine tachysystole compared with pharmacologic agents.
Nipple stimulation is a non-pharmacologic, physiologic method that promotes endogenous oxytocin release and uterine contractions, mimicking spontaneous labor. Prior studies have suggested that nipple stimulation may reduce the need for exogenous oxytocin and lower the incidence of uterine hyperstimulation, while achieving comparable maternal and neonatal outcomes. However, the combined use of nipple stimulation with mechanical cervical ripening has not been systematically evaluated.
This study is a prospective, randomized, double-blinded controlled trial designed to evaluate whether the addition of nipple stimulation to Foley balloon catheter cervical ripening improves cervical readiness and shortens the induction-to-delivery interval compared with Foley balloon catheter alone. Eligible participants are term pregnant patients (37-42 weeks' gestation) with singleton, cephalic pregnancies, intact membranes, and an unfavorable cervix (Bishop score <6) who require labor induction for standard obstetric indications.
Participants will be randomized in a 1:1 ratio to one of two study groups. The intervention group will undergo cervical ripening with a Foley balloon catheter in combination with a standardized nipple stimulation protocol using a breast pump. Nipple stimulation will begin one hour after catheter insertion and will consist of alternating stimulation of each breast for 15 minutes with 15-minute rest intervals, for up to six hours, at the maximum tolerable intensity. The control group will receive cervical ripening with a Foley balloon catheter alone, with standard obstetric management.
Fetal heart rate monitoring will be performed at regular intervals according to institutional protocols, with increased monitoring as clinically indicated. The balloon catheter will be removed after 12 hours, earlier if spontaneous labor ensues, membranes rupture, uterine tachysystole occurs, or non-reassuring fetal status is suspected.
Primary outcomes include the change in Bishop score following catheter removal and the induction-to-delivery interval. Secondary outcomes include the need for additional induction methods (e.g., oxytocin or prostaglandins), time to active labor, mode of delivery, maternal complications (including intrapartum fever, chorioamnionitis, postpartum hemorrhage, and uterine tachysystole), neonatal outcomes (Apgar scores, umbilical cord pH, NICU admission), maternal pain and satisfaction scores, and breastfeeding rates.
The findings of this study will provide evidence regarding the efficacy and safety of integrating a physiologic intervention with mechanical cervical ripening and may inform future strategies to optimize labor induction while minimizing pharmacologic exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foley Balloon Catheter Combined With Nipple Stimulation | Experimental | Procedure: Foley balloon catheter with nipple stimulationParticipants 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). |
| Foley Balloon Catheter Alone | Active comparator | Procedure: Mechanical cervical ripening with Foley catheterParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant individuals aged ≥18 years
- Singleton pregnancy
- Term gestation (37-42 weeks)
- Cephalic fetal presentation
- Intact membranes
Key exclusion criteria (8 listed)
- Multiple gestation
- Previous cesarean delivery or uterine surgery
- Contraindication to vaginal delivery
- Major fetal anomalies
- Active labor at enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foley balloon catheter with nipple stimulationMechanical 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 | Procedure or surgery | Foley Balloon Catheter Combined With Nipple Stimulation |
| Mechanical cervical ripening with Foley catheterMechanical 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. | Procedure or surgery | Foley Balloon Catheter Alone |
Primary outcome
Induction-to-delivery interval
Time frame: From Foley balloon catheter insertion until delivery (up to 48 hours)
Defined as the time (in hours) from Foley balloon catheter insertion until delivery.
Change in Bishop score
Time frame: From Foley balloon catheter insertion until catheter removal (up to 12 hours)
Defined as the difference between the Bishop score before Foley balloon catheter insertion and after catheter removal.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Results publication: PubMed 16034897Kavanagh 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.
- Results publication: PubMed 40054666Abu 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.
- Results publication: PubMed 31623014de 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. De-identified aggregate data may be presented in scientific publications and presentations in accordance with institutional policies and ethical approvals.
Related trials for Induction of Labor
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maya Frank Wolf, Prof. study chair
Galilee Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Foley balloon catheter with nipple stimulation and Mechanical cervical ripening with Foley catheter in people with Induction of Labor and Cervical Ripening, run by Western Galilee Hospital-Nahariya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Frank Wolf Frank Wolf, Prof. (+9729107723, mayaw@gmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction-to-delivery interval (time frame: From Foley balloon catheter insertion until delivery (up to 48 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07317674, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.