- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07588529
Is Nipple Stimulation Effective for Inducing Labor and Acceptable to Patients, Nurses, and Providers? (NSAIL)
Nipple Stimulation Acceptability for Induction of Labor
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
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
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
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
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Kansas
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Kansas City, Kansas, Estados Unidos, 66103
- University of Kansas Medical Center
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Contacto:
- Rachel Diteresi, MD
- Número de teléfono: 913-588-6200
- Correo electrónico: rditeresi@kumc.edu
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Contacto:
- Brian Brost, MD
- Número de teléfono: 913-588-6259
- Correo electrónico: bbrost@kumc.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
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
¿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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total Duration of Labor
Periodo de tiempo: From beginning of induction of labor to delivery of the baby (for each patient).
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The investigators will measure the time between induction of labor initiation and delivery of the baby.
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From beginning of induction of labor to delivery of the baby (for each patient).
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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).
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From beginning of induction of labor to delivery of the baby (for each patient).
|
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Average maximum concentration of Pitocin
Periodo de tiempo: From beginning of induction of labor to delivery of the baby (for each patient).
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The investigators will measure the average maximum concentration of Pitocin needed for each study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental).
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From beginning of induction of labor to delivery of the baby (for each patient).
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Delivery method
Periodo de tiempo: Time taken for delivery of newborn
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Delivery method (C-section, spontaneous vaginal, or operative vaginal) by percentage needed for each study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental).
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Time taken for delivery of newborn
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Maternal adverse events
Periodo de tiempo: From beginning of induction of labor to patient being discharged in postpartum period.
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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).
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From beginning of induction of labor to patient being discharged in postpartum period.
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NICU admission
Periodo de tiempo: From delivery of newborn to discharge from hospital.
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Percentage of newborns requiring NICU admission per study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental).
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From delivery of newborn to discharge from hospital.
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APGAR score
Periodo de tiempo: In the minutes directly after delivery
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Average APGAR score of newborns in each study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental).
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In the minutes directly after delivery
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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.
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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.
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From before patient participation to after all patients (48 total) have participated.
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Colaboradores e Investigadores
Patrocinador
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
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00161207
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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