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

Официальное название

Nipple Stimulation Acceptability for Induction of Labor

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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).

Первичные конечные точки

• Total Duration of Labor [Срок оценки: From beginning of induction of labor to delivery of the baby (for each patient).]

Вторичные конечные точки (7)

• Average amount of Pitocin used [Срок оценки: From beginning of induction of labor to delivery of the baby (for each patient).]
• Average maximum concentration of Pitocin [Срок оценки: From beginning of induction of labor to delivery of the baby (for each patient).]
• Delivery method [Срок оценки: Time taken for delivery of newborn]
• Maternal adverse events [Срок оценки: From beginning of induction of labor to patient being discharged in postpartum period.]
• NICU admission [Срок оценки: From delivery of newborn to discharge from hospital.]
• APGAR score [Срок оценки: In the minutes directly after delivery]
• Acceptability of nipple stimulation as an induction of labor method [Срок оценки: From before patient participation to after all patients (48 total) have participated.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Kansas Medical Center — Kansas City

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT07588529 · STUDY00161207

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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