RecruitingPhase 4NCT05079841

The Stimulation To Induce Mothers Study

The Stimulation To Induce Mothers (STIM) Study: A Parallel Group Randomized Controlled Trial

Sponsor

Yale University

Enrollment

988 participants

Start Date

Nov 15, 2021

Study Type

INTERVENTIONAL

Conditions

Labor Pain Oxytocin Physiologic Effects of Drugs Induction of Labor Affected Fetus / Newborn

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether nipple stimulation using an electric breast pump can help start or speed up labor in women who are already receiving oxytocin (a hormone used to induce or strengthen contractions). The goal is to see if this addition can shorten labor time and reduce the amount of oxytocin needed. You may be eligible if... - You are at least 18 years old - This is your first pregnancy (nulliparous) - You are at least 36 weeks pregnant with a single baby - Your baby is in the head-down position - You are already planned to receive IV oxytocin to start or strengthen labor - Your water has broken or your cervix is favorably positioned for induction (Bishop score 5+) and dilated less than 6 cm You may NOT be eligible if... - You are carrying twins or multiples - You are scheduled for a planned cesarean section - You have an active genital herpes outbreak, placenta previa, or other condition that prevents vaginal delivery - You have HIV (nipple stimulation is discouraged for mothers who should not breastfeed) - You have had a mastectomy or cannot use a breast pump - You have signs of fetal distress (late decelerations, bradycardia) in the 30 minutes before enrollment - The baby has a major known abnormality requiring immediate intensive care Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEElectric breast pump

Participants randomized to the intrapartum nipple stimulation will use electric breast pump or nipple stimulate by hand (if preferred) (intervention) to induce labor for at least 2 hours

DRUGExogenous oxytocin intravenous infusion without nipple stimulation.

Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor as current standard of care