CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 348 enrolled
Drug / intervention
Laboraide TM dental support devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03138798
NCT03138798N/ACompleted
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Dental Support Device in the Second Stage of Labor at a Major Tertiary Care Center; A Randomized Controlled Trial

Angela Bianco·interventional·Posted May 3, 2017·Updated Dec 11, 2018

In Brief

A clinical study evaluating Laboraide TM dental support device for Labor. Completed, enrolled 348 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLabor
CountriesUnited States
CollaboratorsIcahn School of Medicine at Mount Sinai

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 3, 2017
Enrollment StartJan 6, 2017
Primary CompletionNov 7, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.2 years ago

Interventions

Laboraide TM dental support devicedevice

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.