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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05079841
The ClinicalTrials.gov registry entry for NCT05079841 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 988 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 133-participant average among 14 other Labor Pain trials with a reported enrollment target (643% higher). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.
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Related
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