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

NCT07588529 | Not Yet Recruiting DMC

• 1 other identifier: STUDY00161207
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy; Induction of Labor

Keywords

nipple stimulation; breast stimulation; induction; labor; induction of labor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Average amount of Pitocin used

  From beginning of induction of labor to delivery of the baby (for each patient).

• Average maximum concentration of Pitocin

  From beginning of induction of labor to delivery of the baby (for each patient).

• Delivery method

  Time taken for delivery of newborn

• Maternal adverse events

  From beginning of induction of labor to patient being discharged in postpartum period.

• NICU admission

  From delivery of newborn to discharge from hospital.

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Nipple Stimulation

EXPERIMENTAL

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

Interventions

Electric breast pump for nipple stimulation OTHER

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.

Nipple Stimulation

induction of labor OTHER

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).

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

Location

Related Publications (3)

• Chayen B, Tejani N, Verma U. Induction of labor with an electric breast pump. J Reprod Med. 1986 Feb;31(2):116-8.

  PMID: 3959016 BACKGROUND

• 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.

  PMID: 35042047 BACKGROUND

• 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.

  PMID: 7839936 BACKGROUND

MeSH Terms

Interventions

Labor, Induced

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Brian Brost, MD

  Vice Chair of Education and Innovation in the Department of Obstetrics and Gynecology at the University of Kansas School of Medicine

  STUDY CHAIR

• Rachel DiTeresi, MD

  Clerkship Director for Obstetrics and Gynecology Department at KUMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bethany Snyder

CONTACT

9135233650; bsnyder3@kumc.edu

Rachel DiTeresi, MD

CONTACT

913-588-6200; rditeresi@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Obstetrics and Gynecology

Model Details: Pilot randomized controlled trial comparing induction of labor with Pitocin (control) against the standard protocol with the addition of nipple stimulation (experimental). Surveys to evaluate patient experience, nursing acceptability, and provider acceptability. Nulliparous (has never delivered before) and multiparous (has delivered at least one child previously) patients will each be randomized into experimental and control sections. 48 patients total to be enrolled, with 24 in each group.

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: May 14, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)