Is Nipple Stimulation Effective for Inducing Labor and Acceptable to Patients, Nurses, and Providers? (NSAIL)

Nipple Stimulation Acceptability for Induction of Labor

In this study the investigators will be testing the use of the Symphony PLUS® breast pump for nipple stimulation. Typically, breast pumps are used to start breast milk production and collect breast milk in patients after delivering their baby. The device uses cup-shaped pieces called flanges that are placed over the patient's nipples and then a gentle vacuum or suction is applied. The mechanical effect of the suction on the nipple is thought to cause the release of a substance called oxytocin in one's body, which encourages labor and contractions to begin. Some reasons why nipple stimulation might be better than other induction of labor methods are that it allows the patient to have more control over their induction process, it uses the patient's own oxytocin instead of synthetic (or factory-produced) oxytocin, and it may shorten the time that it takes to deliver the baby.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy; Induction of Labor
• Intervention / Treatment: Other: induction of labor; Other: Electric breast pump for nipple stimulation

Detailed Description

Patients will be randomly assigned (like rolling the dice) to one of 2 groups.

• Group 1 will follow the standard induction of labor protocol at KUMC. In other words, their induction process will not look any different than if they were not a participant in this study. Their induction process may include, but is not limited to, medications and/or devices to make the body more ready to deliver the baby, medications to increase the uterus muscle contractions, medications to decrease the pain associated with labor, etc. Group 1 will not use nipple stimulation at all as part of their labor.
• Group 2 will follow the standard induction of labor protocol with the addition of nipple stimulation using the Symphony PLUS® breast pump for a 2-hour time period. At the time in their labor when the medical team would normally deem them appropriate to initiate synthetic oxytocin (Pitocin), nipple stimulation will be started instead. The breast pump will be placed over one nipple at a time and put on its default vacuum settings. Every 15 minutes, the patient will switch to stimulating the alternate nipple with no breaks of time in between. Depending on how fast the contractions are, the research team may increase or decrease the strength of the breast pump. This will continue for 2 hours, after which they will stop doing nipple stimulation. They will then resume normal induction of labor care as deemed appropriate by the nurses and doctors.

Patients will have a 1 in 2 chance (50%) of being randomized to either Group 1 or Group 2. Group assignments will be chosen by a randomization tool. Patients and the study team will be aware of which treatment they are under.

After delivering the baby, both groups will take a survey about their induction experience while they are in the hospital. After the survey is collected, patients have completed participation in this study. Patients will continue to receive standard care with their primary physician team.

The investigators will take information about the patients and their medical care from the electronic medical record for research purposes. The investigators will be analyzing things such as how long it took from the beginning of induction to the delivery of the baby, if there were any unexpected events, how much synthetic oxytocin was used, and other information about the induction and the health of the baby. The investigators will also analyze the results of the surveys completed.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bethany Snyder; Phone Number: 9135233650; Email: bsnyder3@kumc.edu
• Study Contact Backup: Name: Rachel Diteresi, MD; Phone Number: 913-588-6200; Email: rditeresi@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • University of Kansas Medical Center
      • Contact: Rachel Diteresi, MD; Phone Number: 913-588-6200; Email: rditeresi@kumc.edu
      • Contact: Brian Brost, MD; Phone Number: 913-588-6259; Email: bbrost@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

All patients presenting to KUMC labor & delivery for IOL will be considered for this study.

Maternal

• ≥18 years old and ≤ 50 years old
• ≥37wga and ≤ 42wga
• Intact amniotic membranes
• English speaking Fetal
• Cephalic presentation

Exclusion Criteria:

Maternal

• Inability to give informed consent
• History of cesarean delivery or uterine myomectomy
• History of uterine rupture
• Intrahepatic cholestasis of pregnancy
• Maternal life-threatening conditions
• Active HSV
• Gestational hypertension, Preeclampsia (severe or w/o severe features), HELLP, chronic hypertension on medications

Placental

• Placenta previa, vasa previa
• Suspicion for abnormally adherent placenta
• Chorioamnionitis
• Placental abruption

Fetal

• Multifetal gestation
• category 2 or 3 fetal heart tracing upon presentation (does not include isolated variable deceleration)
• EFW > 5000 grams in mother with diabetes
• EFW > 4500 grams in mother without diabetes
• Fetal demise
• Fetal growth restriction <10th centile
• Any other contraindication for vaginal birth or anticipation of need for NICU for care of baby

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Patients randomized to the control group will follow standard induction of labor protocol, which may include, but is not limited to, misoprostol, Foley catheter, and synthetic oxytocin (Pitocin). In other words, their induction will be the same as if they were not enrolled in the study.	Other: induction of labor; Patients randomized to the control group will follow standard induction of labor protocol, which may include, but is not limited to, misoprostol, Foley catheter, and synthetic oxytocin (Pitocin).
Experimental: Nipple Stimulation; Patients randomized to the experimental group will undergo standard IOL protocol with the addition of nipple stimulation. At the time when the labor and delivery team deems a patient suitable for Pitocin initiation, patients will begin using a Symphony PLUS® breast pump for nipple stimulation. The breast pump will be turned on and placed on one breast (around the nipple) for 15 minutes, alternating breasts every 15 minutes. The default pump vacuum settings will be utilized. Contraction pattern and pump settings will be assessed every 30 minutes and adjusted if needed to maintain uterine contractions at a rate between 3 and 5 contractions per 10 minutes averaged over 30 minutes. Patients will perform nipple stimulation for no greater and no less than 2 hours. They will then resume normal care.	Other: Electric breast pump for nipple stimulation; Symphony PLUS® breast pump. What distinguishes this induction of labor nipple stimulation study is how we will be applying the nipple stimulation. Many other studies exist, but they apply the stimulation in an uneven or inconsistent manner. They often do not specify how they interpret active and latent labor. Our study will be using nipple stimulation only for 2 hours per experimental participant so that we can better quantify the effect that nipple stimulation has on the labor process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Duration of Labor	The investigators will measure the time between induction of labor initiation and delivery of the baby.	From beginning of induction of labor to delivery of the baby (for each patient).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average amount of Pitocin used	Average Pitocin per patient used in the different study arms (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental).	From beginning of induction of labor to delivery of the baby (for each patient).
Average maximum concentration of Pitocin	The investigators will measure the average maximum concentration of Pitocin needed for each study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental).	From beginning of induction of labor to delivery of the baby (for each patient).
Delivery method	Delivery method (C-section, spontaneous vaginal, or operative vaginal) by percentage needed for each study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental).	Time taken for delivery of newborn
Maternal adverse events	Adverse events (uterine tachysystole, postpartum hemorrhage, any other adverse event) by percentage that occur in each study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental).	From beginning of induction of labor to patient being discharged in postpartum period.
NICU admission	Percentage of newborns requiring NICU admission per study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental).	From delivery of newborn to discharge from hospital.
APGAR score	Average APGAR score of newborns in each study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental).	In the minutes directly after delivery
Acceptability of nipple stimulation as an induction of labor method	Surveys will be administered to patients in their postpartum period, labor and delivery nurses after the patient portion of the study has been completed, and OBGYN providers Pre and Post patient portion of the study. These surveys will ask about familiarity with nipple stimulation, how they liked using it, and if they would use it again for induction of labor.	From before patient participation to after all patients (48 total) have participated.

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Study Chair: Brian Brost, MD, Vice Chair of Education and Innovation in the Department of Obstetrics and Gynecology at the University of Kansas School of Medicine; Principal Investigator: Rachel DiTeresi, MD, Clerkship Director for Obstetrics and Gynecology Department at KUMC

Publications and helpful links

General Publications

• Adewole IF, Franklin O, Matiluko AA. Cervical ripening and induction of labour by breast stimulation. Afr J Med Med Sci. 1993 Dec;22(4):81-5.
• Chayen B, Tejani N, Verma U. Induction of labor with an electric breast pump. J Reprod Med. 1986 Feb;31(2):116-8.
• Stark EL, Athens ZG, Son M. Intrapartum nipple stimulation therapy for labor induction: a randomized controlled external pilot study of acceptability and feasibility. Am J Obstet Gynecol MFM. 2022 Mar;4(2):100575. doi: 10.1016/j.ajogmf.2022.100575. Epub 2022 Jan 15.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: labor; induction; induction of labor; nipple stimulation; breast stimulation
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Delivery, Obstetric; Obstetric Surgical Procedures; Labor, Induced
• Other Study ID Numbers: STUDY00161207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No