Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05079841 · ClinicalTrials.gov registry record · Phase 4
The Stimulation To Induce Mothers Study
A Phase 4 study of Labor Pain and Oxytocin, sponsored by Yale University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 988
- Enrollment target
- 3
- Study locations
NCT05079841: Recruiting Phase 4 study of Labor Pain and Oxytocin, sponsored by Yale University.
NCT05079841 is a Phase 4 study of Labor Pain and Oxytocin that is actively recruiting participants, run by Yale University. The registered enrollment target is 988 participants, above the 133-participant average among 14 other Labor Pain trials with a reported enrollment target (643% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05079841, a Phase 4 study of Labor Pain and Oxytocin, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 988 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
Spontaneous vaginal delivery will be defined as delivery that occurs without the use of forceps, vacuum, or cesarean
Conditions Studied
Interventions
- DEVICE Electric breast pump
- DRUG Exogenous oxytocin intravenous infusion without nipple stimulation.
Study Locations (3)
Connecticut
- Yale New Haven Hospital - New Haven
Illinois
- Northwestern Memorial Hospital - Chicago
New York
- Weill Cornell Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 988 participants |
| Start Date | 2021-11-15 |
| Est. Completion | 2029-03 |
| Phase | Phase 4 |
What NCT05079841 shows while recruiting
NCT05079841 is an interventional study that assigns participants to a tested intervention. The registered 988 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 14 other Labor Pain trials with a reported enrollment target (643% higher).
The record links to 4 conditions, with Labor Pain appearing as the primary indexed condition, and to 2 interventions - of which Electric breast pump is the first listed.
NCT05079841 reports a single indexed study location in Connecticut, Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT05079841 about?
NCT05079841 is a clinical study titled "The Stimulation To Induce Mothers Study". 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...
What is the current status of trial NCT05079841?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 988 participants. The study started on 2021-11-15. Estimated completion is 2029-03.
What conditions does trial NCT05079841 study?
This clinical trial studies the following conditions: Labor Pain, Oxytocin, Induction of Labor Affected Fetus / Newborn, Physiologic Effects of Drugs.
What interventions are being tested in trial NCT05079841?
The interventions under investigation include: Electric breast pump (DEVICE), Exogenous oxytocin intravenous infusion without nipple stimulation. (DRUG).
Who is sponsoring clinical trial NCT05079841?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05079841 being conducted?
This trial has 3 study locations across Connecticut, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Labor Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05079841's enrollment target sits among peer trials
988 1st of 14 higher than 14 of 14 other Labor Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Labor Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
ED90 of Bupivacaine After Lidocaine Test Dose with DPE and EPL
RECRUITING · Phase 4
-
Comparison of PIEB vs CEI for Labor Analgesia
COMPLETED · Phase 4
-
DPE Technique in Labor Epidural for Morbidly Obese Women
COMPLETED · Phase 4
-
Optimal Bupivacaine Dose for Initiation of Labor Epidural Techniques
COMPLETED · Phase 4
-
Intracervical Balloon Placement With Nitrous Oxide Administration
RECRUITING · Phase 3
-
CSE v. Epidural for Postpartum Depression
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05441709 · 990 participants · NA
Furthering Equity Through Infant Feeding EDucation and Support
- NCT06340646 · 990 participants · NA
Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS)
- NCT06878261 · 990 participants · Phase 3
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
- NCT06883305 · 990 participants · Phase 3
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI