The Stimulation To Induce Mothers Study

Summary

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.

Conditions

• Oxytocin
• Labor Pain
• Induction of Labor Affected Fetus / Newborn
• Physiologic Effects of Drugs

Interventions

DEVICE

Electric breast pump

Participants randomized to the intrapartum nipple stimulation will use electric breast pump or nipple stimulate by hand (if preferred) (intervention) to induce labor for at least 2 hours

DRUG

Exogenous oxytocin intravenous infusion without nipple stimulation.

Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor as current standard of care

Sponsors & Collaborators

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

  collaborator NIH

• Yale University

  lead OTHER

Principal Investigators

• Molly McAdow, MD, PhD · Yale University

• Bethany Stetson, MD · Northwestern University

• Moeun Son, MD, MSCI · Weill Medical College of Cornell University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-11-15

Primary Completion

2028-11-30

Completion

2029-03-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations