About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old and ≤ 50 years old
≥37wga and ≤ 42wga
Intact amniotic membranes
English speaking Fetal
Disqualifiers
Inability to give informed consent
History of cesarean delivery or uterine myomectomy
History of uterine rupture
Intrahepatic cholestasis of pregnancy
Trial design
Parallel
Treatments tested in this trial
Electric breast pump for nipple stimulation
Other interventionSymphony 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.
induction of labor
Other interventionPatients 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).
Treatment groups
Trial outcomes
Primary outcomes
Total Duration of Labor
The investigators will measure the time between induction of labor initiation and delivery of the baby.
Secondary outcomes
Average amount of Pitocin used
Average Pitocin per patient used in the different study arms (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental).
Average maximum concentration of Pitocin
The investigators will measure the average maximum concentration of Pitocin needed for each study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental).
Delivery method
Delivery method (C-section, spontaneous vaginal, or operative vaginal) by percentage needed for each study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental).
Maternal adverse events
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).
Sponsors and contacts
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