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RECRUITING Phase 4

The Stimulation To Induce Mothers Study

NCT05079841 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 988 participants
Start Date 2021-11-15
Est. Completion 2029-03
Phase Phase 4

Sponsor

Yale University

1,283 total trials

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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 988 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,283 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05079841 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Connecticut, Illinois, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05079841?

This trial is sponsored by Yale University, which has 1,283 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial