The Stimulation To Induce Mothers Study

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorYale University

About 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, 2) Breastfeeding as the sole source of nutrition at time of maternal hospital discharge (Primary Aims); 3) Maximal percent newborn weight loss during the birth hospitalization within 72 hours of life, 4) Determine the effect of intrapartum nipple stimulation on the rate of adverse maternal and neonatal outcomes, 5) Determine the impact of intrapartum nipple stimulation on patient-centered outcomes and 6) In a sub-cohort of women who are enrolled in the trial, investigators will measure the change in oxytocin concentration from baseline to time at which patient achieves a regular contraction pattern.

Eligibility criteria

Qualifiers

Nulliparous

Gestational age 36 0/7 weeks and greater at enrollment

Singleton gestation

Planned to undergo initiation of exogenous oxytocin infusion by their maternity care provider

Disqualifiers

Unable to understand English or Spanish

Prior use of exogenous oxytocin or attempt at nipple stimulation during the current pregnancy

Presence of tachysystole (defined as more than 5 contractions in 10 minutes averaged over 30 minutes), recurrent variable or late fetal decelerations, and bradycardia in the prior 30 minutes before enrollment

Non-vertex presenting fetus at time of enrollment

Trial design

Treatments tested in this trial

  • Electric breast pump
  • Exogenous oxytocin intravenous infusion without nipple stimulation.

Treatment groups

988 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yale University

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator