NCT05079841 · Yale University
The Stimulation To Induce Mothers Study
(STIM)
What this study is about
The investigators propose a parallel group randomly assigned clinical trial of intrapartum nipple stimulation versus exogenous oxytocin infusion for nulliparous women undergoing induction of labor near term.
View original scientific description
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.
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
Primary outcome measures
Spontaneous vaginal delivery
Time frame: At delivery
Spontaneous vaginal delivery will be defined as delivery that occurs without the use of forceps, vacuum, or cesarean
Breastfeeding as the sole source of nutrition (BSSN)
Time frame: up to 72 hours following delivery
Number of participants using breastfeeding as the sole source of nutrition (BSSN) at time of maternal discharge or 72 hours of life (whichever is sooner)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Spontaneous rupture of membranes or if membranes intact, modified Bishop score ≥5 and cervix dilated \<6 cm within one hour of enrollment
- Ability to give informed consent
Exclusion criteria
- 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
- Planned for cesarean delivery or contraindication to labor by institutional policy (e.g., placenta previa, vasa previa, active genital herpes infection, previous transmural myomectomy)
Where
- New Haven, Connecticut
- Chicago, Illinois
- New York, New York
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 24, 2026 · Source of record for eligibility and locations