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Clinical Trial

The Stimulation To Induce Mothers Study

NCT: NCT05079841 · ACTIVE_NOT_RECRUITING

NCT IDNCT05079841
StatusACTIVE_NOT_RECRUITING
Start Date2021-11-15
Completion2029-03
SponsorYale University (OTHER)
First posted
Last updated

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.

Frequently Asked Questions

What is The Stimulation To Induce Mothers Study?

The Stimulation To Induce Mothers Study is a clinical trial registered under NCT05079841. Current status: ACTIVE_NOT_RECRUITING.

What is the status of NCT05079841?

The current status of NCT05079841 (The Stimulation To Induce Mothers Study) is: ACTIVE_NOT_RECRUITING.

When did The Stimulation To Induce Mothers Study start?

The Stimulation To Induce Mothers Study started on 2021-11-15.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.