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Dental Support Device in the Second Stage of Labor

NCT03138798 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2018-12-11

Study results available
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Summary

Obstetric practices now allow for prolonged second stage of labor to accomplish vaginal delivery. However, this practice may lead to either operative delivery (vacuum or forceps assisted delivery) or cesarean section with significant maternal/neonatal morbidity. Limited evidence suggests that dental support devices (DSD) may improve lead to shortened labor by allowing patients to push more effectively.

Conditions

  • Labor

Interventions

DEVICE

Laboraide TM dental support device

Patients will give consent in the first stage of labor. Subsequently a randomization will be performed using sealed envelopes opened at the time of pushing in the second stage of labor. Women assigned to Group A will received a sealed Laboraide TM package. Duration of the second stage and time spent pushing will be recorded. Obstetric management will not be altered by group assignment. Following delivery, patients assigned to Group A will complete a patient satisfaction survey.

Sponsors & Collaborators

Principal Investigators

  • Angela Bianco, MD · Icahn School of Medicine at Mount Sinai

  • Eric Bergh, MD · Ichan School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-06
Primary Completion
2017-11-07
Completion
2017-11-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03138798 on ClinicalTrials.gov