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

8 de mayo de 2026 actualizado por: Rachel DiTeresi, University of Kansas Medical Center

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

48

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Bethany Snyder
  • Número de teléfono: 9135233650
  • Correo electrónico: bsnyder3@kumc.edu

Copia de seguridad de contactos de estudio

  • Nombre: Rachel Diteresi, MD
  • Número de teléfono: 913-588-6200
  • Correo electrónico: rditeresi@kumc.edu

Ubicaciones de estudio

    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66103
        • University of Kansas Medical Center
        • Contacto:
          • Rachel Diteresi, MD
          • Número de teléfono: 913-588-6200
          • Correo electrónico: rditeresi@kumc.edu
        • Contacto:
          • Brian Brost, MD
          • Número de teléfono: 913-588-6259
          • Correo electrónico: bbrost@kumc.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.
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.

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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Total Duration of Labor
Periodo de tiempo: From beginning of induction of labor to delivery of the baby (for each patient).
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).

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Average amount of Pitocin used
Periodo de tiempo: From beginning of induction of labor to delivery of the baby (for each patient).
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
Periodo de tiempo: From beginning of induction of labor to delivery of the baby (for each patient).
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
Periodo de tiempo: Time taken for delivery of newborn
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
Periodo de tiempo: From beginning of induction of labor to patient being discharged in postpartum period.
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
Periodo de tiempo: From delivery of newborn to discharge from hospital.
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
Periodo de tiempo: In the minutes directly after delivery
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
Periodo de tiempo: From before patient participation to after all patients (48 total) have participated.
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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: Brian Brost, MD, Vice Chair of Education and Innovation in the Department of Obstetrics and Gynecology at the University of Kansas School of Medicine
  • Investigador principal: Rachel DiTeresi, MD, Clerkship Director for Obstetrics and Gynecology Department at KUMC

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de diciembre de 2027

Finalización del estudio (Estimado)

1 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

17 de diciembre de 2024

Primero enviado que cumplió con los criterios de control de calidad

8 de mayo de 2026

Publicado por primera vez (Actual)

14 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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