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Recruiting Phase 4 NCT05079841

The Stimulation To Induce Mothers Study

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Plain-language summary for patients

Trial Parameters

Condition Oxytocin
Sponsor Yale University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 988
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2021-11-15
Completion 2028-11
Interventions
Electric breast pumpExogenous oxytocin intravenous infusion without nipple stimulation.

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Brief 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 \<6 cm within one hour of enrollment * Ability to give informed consent Exclusion Criteria: * Unable to understand English or Spanish * Prior use of exogenous oxytocin or attempt at nipple stimulation during the current pregnancy * Presence of tachysystole (defined as more than 5 contractions in 10 minutes averaged over 30 minutes), recurrent variable or late fetal decelerations, and bradycardia in the prior 30 minutes before enrollment * Non-vertex presenting fetus at time of enrollment * Planned for cesarean delivery or contraindication to labor by institutional policy (e.g., placenta previa, vasa previa, active genital herpes infection, previous transmural myomectomy) * Multi-

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