Nipple stimulation versus oxytocin for inducing labor in first-time mothers
The Stimulation To Induce Mothers (STIM) Study: A Parallel Group Randomized Controlled Trial
This study tests whether nipple stimulation can help first-time moms have their babies more easily compared to using oxytocin.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 988 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Yale University Academic / other |
| Locations | 3 sites (New Haven, Connecticut and 2 other locations) |
| Trial ID | NCT05079841 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of intrapartum nipple stimulation to exogenous oxytocin infusion for inducing labor in nulliparous women. The study aims to determine if nipple stimulation can increase the rate of spontaneous vaginal deliveries and improve maternal and neonatal outcomes. Participants will be randomly assigned to receive either nipple stimulation or oxytocin infusion, and various outcomes such as childbirth satisfaction, pain scores, and breastfeeding success will be assessed. The trial is designed to provide insights into patient-centered outcomes and the physiological effects of these interventions.
Who should consider this trial
Good fit: Ideal candidates are nulliparous women at 36 weeks gestation or greater who are planning to undergo labor induction.
Not a fit: Patients who have had prior use of oxytocin or nipple stimulation during the current pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to higher rates of spontaneous vaginal delivery and improved maternal and neonatal health outcomes.
How similar studies have performed: Other studies have explored similar methods, but this specific approach of nipple stimulation versus oxytocin infusion is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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) * Multi-fetal gestation (e.g., twins, triplets, and higher-order multiples) * Intrauterine fetal death * Major fetal anomaly suspected prenatally (defined as a fetal anomaly with anticipated neonatal intensive care unit admission) * Suspected alloimmunization (given the increased likelihood for anticipated neonatal intensive care unit admission) * Known severe fetal growth restriction (estimated fetal weight \<3rd percentile) or abnormal umbilical artery Doppler studies (given the increased likelihood for anticipated neonatal intensive care unit admission) * HIV infection (nipple stimulation is not encouraged given the recommendation for these mothers not to breastfeed) * Participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality * History of mastectomy or other contraindication to use of electronic breast pump * Known allergic reactions to components of the electronic breast pump or to synthetic oxytocin intravenous solution * Significantly impaired consciousness or executive function (e.g., intubated or sedated)
Where this trial is running
New Haven, Connecticut and 2 other locations
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Active_not_recruiting)
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Molly McAdow, MD, PhD — Yale University
- Study coordinator: Moeun Son, MD, MSCI
- Email: mos7003@med.cornell.edu
- Phone: (212) 746-2106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.