Stimulation Therapy to Induce Mothers (STIM): Protocol for a Multicenter Randomized Controlled Trial (Preprint)

Abstract

Over 1 million women have their labor induced in the United States each year, and synthetic oxytocin infusion 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 endogenous oxytocin hormone which is released in a pulsatile fashion in the brain, synthetic oxytocin is continuously infused intravenously, resulting in important limitations related to efficacy, safety, and cost. Akin to spontaneous labor contractions, infant suckling of the breast nipple is known to stimulate the pulsatile release of endogenous oxytocin from the posterior pituitary gland. Nipple stimulation therapy via electric breast pump similarly stimulates endogenous oxytocin release and may be a favorable inpatient method for patients undergoing labor induction.

To examine whether inpatient nipple stimulation therapy is an efficacious labor induction method that increases the likelihood of spontaneous vaginal delivery and sustained breastfeeding and determine whether it is a cost-effective approach.

This is a multicenter, pragmatic, open-label, parallel group randomized trial of nulliparous patients with singleton gestations 36 weeks undergoing labor induction. This trial compares inpatient nipple stimulation therapy via electric breast pump versus immediate synthetic oxytocin infusion without nipple stimulation. This trial of 988 nulliparas will provide adequate statistical power to detect clinically meaningful differences in delivery mode and breastmilk as the sole source of nutrition for newborns at hospital discharge or 72 hours of birth.

The project received pilot funding in 2021 and full funding in 2023. Enrollment began in November 2021 at a single site and is now being conducted at three recruiting sites. It is anticipated that enrollment will be completed in late 2026.

Successful completion of this trial will provide rigorous data to determine whether inpatient nipple stimulation therapy with an electric breast pump can improve the way we induce labor and positively impact breastfeeding success and early infant nutrition through lactation.

ClinicalTrials.gov NCT05079841