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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Kansas Medical Center

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 volunteers

Qualifiers

≥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

Design model

Parallel

Treatments tested in this trial

  • Electric breast pump for nipple stimulation

    Other intervention

    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.

  • induction of labor

    Other intervention

    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).

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: Nipple StimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total Duration of Labor

The investigators will measure the time between induction of labor initiation and delivery of the baby.

Time frame
From beginning of induction of labor to delivery of the baby (for each patient).

Secondary outcomes

1

Average amount of Pitocin used

Average Pitocin per patient used in the different study arms (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental).

Time frame
From beginning of induction of labor to delivery of the baby (for each patient).
2

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).

Time frame
From beginning of induction of labor to delivery of the baby (for each patient).
3

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).

Time frame
Time taken for delivery of newborn
4

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).

Time frame
From beginning of induction of labor to patient being discharged in postpartum period.

Other outcomes

Sponsors and contacts

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