Actively Recruiting
The Stimulation To Induce Mothers Study
Led by Yale University · Updated on 2026-03-24
988
Participants Needed
3
Research Sites
380 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Stimulation To Induce Mothers Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Nulliparous women
- At least 36 weeks gestation at enrollment
- Single fetus pregnancy
- Planned initiation of oxytocin infusion for labor induction
- Spontaneous rupture of membranes or if intact, cervical readiness score 5 or higher and dilation less than 6 cm within 1 hour of enrollment
- Ability to provide informed consent
You will not qualify if you...
- Unable to understand English or Spanish
- Prior use of oxytocin or nipple stimulation during this pregnancy
- Excessive contractions or abnormal fetal heart rate patterns within 30 minutes before enrollment
- Fetus not in head-down position at enrollment
- Planned cesarean or medical reasons preventing labor
- Multiple pregnancies (twins or more)
- Fetal death or major fetal abnormalities
- Suspected immune complications affecting newborn care
- Severe fetal growth restriction or abnormal blood flow in umbilical artery
- HIV infection
- Participation in another labor-related interventional study
- History of breast surgery or contraindication to breast pump use
- Allergies to breast pump parts or oxytocin solution
- Severe impaired consciousness or sedation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Active, Not Recruiting
3
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
Research Team
M
Moeun Son, MD, MSCI
CONTACT
M
Molly McAdow, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here