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Stimulation Therapy for Inducing Mothers

NCT04756089 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-09-05

No results posted yet for this study

Summary

This is a pilot feasibility and acceptability study of a randomized clinical trial of pregnant women at 36 weeks of gestation and greater randomized to one of two arms at Yale New Haven Hospital: (1) Breast stimulation by hand or with an electronic breast pump (intervention) compared to (2) Exogenous oxytocin intravenous infusion (current standard of care, control). The pilot study will be randomized since one of the goals is to evaluate whether the idea of randomization would be acceptable to patients.

Conditions

  • Induced; Birth
  • Labor Long
  • Labor Pain
  • Breast Pumping
  • Lactation Induced

Interventions

DEVICE

Electronic breast pump

Participants randomized to the breast stimulation will use breast stimulation by hand or with an electronic breast pump (intervention) to stimulate labor.

OTHER

Exogenous oxytocin intravenous infusion

Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to stimulate labor.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-13
Primary Completion
2021-06-23
Completion
2021-06-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04756089 on ClinicalTrials.gov