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

8 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

48

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Kansas
      • Kansas City, Kansas, Stati Uniti, 66103
        • University of Kansas Medical Center
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: 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).
Sperimentale: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total Duration of Labor
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Average amount of Pitocin used
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Kansas Medical Center

Investigatori

  • Cattedra di studio: Brian Brost, MD, Vice Chair of Education and Innovation in the Department of Obstetrics and Gynecology at the University of Kansas School of Medicine
  • Investigatore principale: Rachel DiTeresi, MD, Clerkship Director for Obstetrics and Gynecology Department at KUMC

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 dicembre 2027

Completamento dello studio (Stimato)

1 dicembre 2028

Date di iscrizione allo studio

Primo inviato

17 dicembre 2024

Primo inviato che soddisfa i criteri di controllo qualità

8 maggio 2026

Primo Inserito (Effettivo)

14 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY00161207

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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