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Active Not Recruiting
NCT05079841
The Stimulation To Induce Mothers Study
Conditions: Oxytocin, Labor Pain, Induction of Labor Affected Fetus / Newborn, Physiologic Effects of Drugs
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 933
Sponsor: Yale University
Location: Yale New Haven Hospital New Haven Connecticut
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT05079841). StuddyBuddy aggregates publicly available trial information.