Stimulation Therapy to Induce Mothers: Protocol for a Multicenter Randomized Controlled Trial

Background: More than 1 million women have their labor induced in the United States each year, and synthetic oxytocininfusion is the most common method used. However, compared to spontaneous labor, medical induction is resource intensive,has increased obstetric risks, and is associated with less successful breastfeeding. In contrast to the endogenous oxytocin hormone,which is released in a pulsatile fashion in the brain, synthetic oxytocin is continuously infused intravenously, resulting in importantlimitations related to efficacy, safety, and cost. Akin to spontaneous labor contractions, infant suckling of the breast nipple isknown to stimulate the pulsatile release of endogenous oxytocin from the posterior pituitary gland. Nipple stimulation therapyvia an electric breast pump similarly stimulates endogenous oxytocin release and may be a favorable inpatient method for patientsundergoing labor induction.Objective: This study aims to examine whether inpatient nipple stimulation therapy is an efficacious labor induction methodthat increases the likelihood of spontaneous vaginal delivery and sustained breastfeeding and determine whether it is a cost-effectiveapproach.Methods: This is a multicenter, pragmatic, open-label, parallel-group randomized controlled trial of nulliparous patients withsingleton gestations >= 36 weeks undergoing labor induction. This trial compares inpatient nipple stimulation therapy via an electricbreast pump versus immediate synthetic oxytocin infusion without nipple stimulation. This trial including 988 nulliparas willprovide adequate statistical power to detect clinically meaningful differences in delivery mode and breast milk as the sole sourceof nutrition for newborns at hospital discharge or 72 hours after birth.Results: The project received pilot funding in 2021 and full funding in 2023. Enrollment for this study began in November2021 at a single site, and as of May 2024, recruitment is underway at 3 study sites. It is anticipated that enrollment will becompleted by late 2026.Conclusions: Successful completion of this trial will provide rigorous data to determine whether inpatient nipple stimulationtherapy with an electric breast pump can improve the way we induce labor and positively impact breastfeeding success and earlyinfant nutrition through lactation.