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The Stimulation To Induce Mothers Study

Study acronym: STIM
StatusActive, Not Recruiting
PhasePhase 4
Started2021-11-15
View on ClinicalTrials.gov ↗

Amendment history

2026-08-13
notable
Study Status, Study Design, Contacts/Locations v13
Enrollment closed, study ongoing
Enrollment targetestimated 988→confirmed 933
Study sitesdetails revised at 3 of 3 sites
2026-03-19
minor
3 amendments v10-v12
3 re-verifications since 2025-04-11, no change to tracked fields
2025-04-07
minor
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 3 sites
2024-08-02
minor
Study Status v8
Re-verified, no change to tracked fields
2024-01-18
minor
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Arms and Interventions, Outcome Measures, Contacts/Locations v7
Primary completion date2023-11→2028-11
Completion date2024-04→2029-03
Study sites1→3
Secondary endpoints9 to 14 entries
Number of Participants with Postpartum hemorrhage Number of Participants with Severe Postpartum hemorrhage Number of participants with suspected infection Number of maternal deaths Maternal Intensive Care Unit admission Percent newborn weight loss
Primary endpoints1 to 2 entries
Breastfeeding as the sole source of nutrition (BSSN)
Study description+1,974 characters
Primary Objectives 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. Breastfeeding as the sol [...]
Collaborators+87 characters
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Show 6 earlier versions
2023-05-22
minor
Study Status, Study Design, Arms and Interventions v6
Enrollment target562→988
InterventionsElectric breast pump (Device), Exogenous oxytocin intravenous infusion (Drug)→Electric breast pump (Device), Exogenous oxytocin intravenous infusion without nipple stimulation. (Drug)
2023-05-09
minor
2 amendments v4-v5
2 re-verifications since 2023-02-22, no change to tracked fields
2022-01-24
minor
Study Status, Eligibility v3
Eligibility criteria+11 characters
[...] med consent Exclusion Criteria: Unable to understand English or Spanish Prior use of exogenous oxytocin or attempt at nipple stimul [...]
2021-11-15
notable
Not Yet Recruiting→Recruiting Study Status, Oversight, Study Design, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
PhaseNot applicable→Phase 4
Start dateestimated 2021-11→confirmed 2021-11-15
Study sites0→1
2021-11-01
minor
Study Status, Outcome Measures v1
Primary completion date2023-10→2023-11
Start date2021-10→2021-11
Secondary endpoints8 to 9 entries
Lactational mastitis
2021-10-14
minor
Original filing
487 trials monitored
See 35 trials at risk
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.
Trial Details
NCT Number NCT05079841
Lead Sponsor Yale University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Oxytocin, Labor Pain, Induction of Labor Affected Fetus / Newborn, Physiologic Effects of Drugs
Enrollment 933 participants
Start Date 2021-11-15
Primary Completion 2028-11 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-17