The Stimulation To Induce Mothers Study (STIM)
Pregnancy, Childbirth and the Puerperium
What is the purpose of this trial?
The investigators propose a parallel group randomized clinical trial of intrapartum nipple stimulation versus exogenous oxytocin infusion for nulliparous women undergoing induction of labor near term. The central hypothesis is that intrapartum nipple stimulation to induce labor increases spontaneous vaginal delivery, improves patient-centered outcomes such as childbirth satisfaction, labor agentry, and pain scores, and reduces adverse neonatal and maternal outcomes in nulliparous women. The investigators will pursue the following specific aims: 1) Assess the effectiveness of intrapartum nipple stimulation on the rate of spontaneous vaginal delivery in nulliparous women (Primary Aim), 2) Determine the effect of intrapartum nipple stimulation on the rate of adverse maternal and neonatal outcomes (Secondary Aim #1), 3) Determine the impact of intrapartum nipple stimulation on patient-centered outcomes (Secondary Aim #2) and 4) In a sub-cohort of women who are enrolled in the trial, to measure the change in oxytocin concentration from baseline to time at which patient achieves a regular contraction pattern, and to measure correlation between salivary and serum oxytocin concentrations in patients undergoing induction of labor via intrapartum nipple stimulation versus continuous exogenous oxytocin infusion. The investigators estimate that randomizing a total of 562 women will provide adequate statistical power to detect meaningful differences in the primary outcome.
- Ages18 years and older
- GenderFemale only
- Trial withColumbia University
- Start Date11/15/2021
- End Date11/30/2023
- Last Updated12/19/2021
- Study HIC#2000031338