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

University of Kansas

Status: Begins enrollment in 1 month

Conditions: Induction of Labor; Pregnancy

Treatments: Other: induction of labor; Other: Electric breast pump for nipple stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07588529

STUDY00161207

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Control

Active Comparator group

Description:

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.

Treatment:

Other: induction of labor

Nipple Stimulation

Experimental group

Description:

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.

Treatment:

Other: Electric breast pump for nipple stimulation