The Stimulation To Induce Mothers Study

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05079841
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Electric breast pump — DEVICE
    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
  • Exogenous oxytocin intravenous infusion without nipple stimulation. — DRUG
    Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor as current standard of care

Study Details

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.

Key Dates

Start date
Nov 15, 2021
Status verified
Mar 2026
Primary completion
Nov 30, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
988 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Intrapartum nipple stimulation
    Participants randomized to the intrapartum nipple stimulation will use electric breast pump or stimulate by hand (intervention) to induce labor.
  • Active Comparator: Exogenous oxytocin intravenous infusion
    Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor.

Primary Outcome Measure

Spontaneous vaginal delivery [ Time Frame: At delivery ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06510-
Northwestern Memorial HospitalChicagoIllinois60611-
Weill Cornell MedicineNew YorkNew York10065-

Find similar trials in New Haven, CT

By research site
Yale New Haven Hospital· New Haven, CTNorthwestern Memorial Hospital· Chicago, ILWeill Cornell Medicine· New York, NY

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