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
Status
Recruiting
Phase
Phase 4
Enrollment
988
Locations
3
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Full detailed description
Primary Objectives 1. To determine whether intrapartum nipple stimulation therapy with or without synthetic oxytocin changes the likelihood of achieving a spontaneous vaginal delivery compared to receipt of synthetic oxytocin infusion without nipple stimulation to induce labor. 2. Breastfeeding as the sole source of nutrition at time of maternal hospital discharge Secondary Objectives (if applicable) The secondary objectives are as follows: 1. Determine whether intrapartum nipple stimulation therapy with or without synthetic oxytocin changes the likelihood of achieving a spontaneous vaginal delivery compared to receipt of synthetic oxytocin infusion without nipple stimulation to induce labor. 2. Determine if women who perform intrapartum nipple stimulation to induce labor have differences in other obstetric and maternal outcomes 3. Determine if women who perform intrapartum nipple stimulation report differences in pain scores during labor, labor agentry and satisfaction scores, postpartum depression scores, and breastfeeding success compared to women who receive only intrapartum exogenous oxytocin infusion. 4. Determine if women who perform intrapartum nipple stimulation to induce labor have similar fetal and neonatal outcomes compared to women who receive only intrapartum exogenous oxytocin infusion. 5. Maximal percent newborn weight loss during the birth hospitalization within 72 hours of life 6. At Yale, to measure the change in oxytocin concentration from baseline over the course of labor induction in patients undergoing induction of labor via intrapartum nipple stimulation versus continuous exogenous oxytocin infusion. 7. At Yale, to measure circulating plasma and urine concentrations of proteins, microRNA, and small molecules using unbiased "omics" approaches, comparing patients undergoing induction of labor via intrapartum nipple stimulation versus continuous exogenous oxytocin infusion, un-ripened/unlabored control patients, and patients in spontaneous labor.
Interventions
Treatment arms and agents.
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
Timeline
From registration to results.
First posted
Oct 15, 2021
Study start
Nov 15, 2021
Primary completion
Nov 2028
Study completion
Mar 2029
Results posted
Not reported
Registry updated
Mar 24, 2026
Outcomes
What the study measures.
Primary outcomes
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)
Secondary outcomes
Operative vaginal delivery
Time frame · At delivery
Delivery with the assistance of forceps or vacuum, and indication
Cesarean delivery
Time frame · At delivery
Delivery by cesarean section
Labor induction duration
Time frame · At delivery
Time interval from randomization to delivery
Number of Participants with Postpartum hemorrhage
Time frame · From delivery to 24 hours postpartum
Cumulative blood loss of ≥1,000 mL within 24 hours after the birth process
Number of Participants with Severe Postpartum hemorrhage
Time frame · From delivery to 24 hours postpartum
Transfusion; non-elective hysterectomy; use of ≥2 uterotonic medications other than oxytocin; other interventions such as uterine compression sutures, uterine artery ligation or embolization, hypogastric artery ligation, balloon tamponade
Number of participants with suspected infection
Time frame · 3-7 days postpartum
Suspected intraamniotic infection, intrapartum chorioamnionitis, or postpartum endometritis (defined as maternal fever ≥38° Fahrenheit with planned or initiated administration of therapeutic antibiotics) after randomization and prior to delivery hospitalization discharge
Lactational mastitis
Time frame · After delivery to 12 weeks postpartum
Subject-reported occurrence of lactational mastitis
Number of maternal deaths
Time frame · immediately prior to up to immediately post delivery
Incidence of maternal death prior to, during, or post delivery
Maternal Intensive Care Unit admission
Time frame · 3-7 days postpartum
Any admission to the Intensive Care Unit after delivery and prior to delivery hospitalization discharge
Neonatal Intensive Care Unit admission
Time frame · up to 28 days following birth
Any admission to the Neonatal Intensive Care Unit From birth to birth hospitalization discharge or 28 days after birth, whichever is earlier
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- FEMALE
- Healthy volunteers
- Yes
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)
Study locations
3 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Yale New Haven Hospital
New Haven, Connecticut, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Weill Cornell Medicine
New York, New York, United States
Publications
Results and literature.
Related trials
More studies on Oxytocin.
NCT IDStudyPhase / statusEnrollmentUpdated
Efficacy of Intravenous Oxytocin to Speed Recovery After THA
Wake Forest University Health Sciences · Total Hip Arthroplasty
Phase 2
Enrolling by invitation
80
2026-07
Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery
Yale University · Pain · Pituitary Surgery
Phase 2
Not yet recruiting
75
2026-07
Oxytocin to Enhance Integrated Treatment for AUD and PTSD
Medical University of South Carolina · PTSD · Alcohol Use Disorder
Phase 2
Completed
175
2026-07
Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening
University Hospital, Tours · Cervical Ripening · Unfavorable Cervix
Phase 3
Recruiting
1,494
2026-07
Different Medications to Induce Labor
Icahn School of Medicine at Mount Sinai · Pregnancy · Labor
Phase 3
Recruiting
281
2026-07
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Elizabeth Austen Lawson · Vasopressin Deficiency
Phase 1
Recruiting
40
2026-07
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
Massachusetts General Hospital · Arginine Vasopressin Deficiency · Oxytocin Deficiency
Early Phase 1
Recruiting
20
2026-07
Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction
Aalto University · Induction of Birth · Cervical Ripening
Not applicable
Recruiting
40
2026-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.