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Dental Support Device in the Second Stage of Labor

NCT ID: NCT03138798

Last Updated: 2018-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

348 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-06

Study Completion Date

2017-11-07

Brief Summary

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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.

Detailed Description

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In an effort to reduce the rate of cesarean section, obstetric practices now allow for prolonged second stage of labor to accomplish vaginal delivery. However, this practice is not without risks and 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 maternal valsalva and lead to a shortened second stage of labor by allowing them to push more effectively. Previous studies have been underpowered to find statistically significant results.

The Icahn School of Medicine at Mount Sinai has a unique and heterogeneous inner-city population of laboring mothers with marked rates of maternal obesity. The objective is to conduct a randomized controlled trial in which nulliparous patients are asked to use the LaboraideTM, a DSD designed for laboring women, while pushing with contractions in the second stage of labor.

Conditions

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Labor

Keywords

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Labor Second stage Dental device

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will give consent in the first stage of labor. Randomization will then be performed using sealed envelopes at the time of pushing in the second stage of labor. Duration of the second stage and time spent pushing will be recorded for both groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laboraide TM dental support device

Receive Laboraide

Group Type EXPERIMENTAL

Laboraide TM dental support device

Intervention Type 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.

Control Group

Patients will give consent in the first stage of labor. Subsequently, randomization will be performed using sealed envelopes opened at the time of pushing in the second stage of labor. Women assigned to Group B will not receive a Laboraide TM dental support device. Duration of the second stage and time spent pushing will be recorded. Obstetric management will not be altered by group assignment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Dental Device Dental Support Device

Eligibility Criteria

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Inclusion Criteria

* Nulliparous women
* Non-anomalous fetus
* Singleton fetus
* Vertex presentation
* In the first phase of labor
* Full term gestation (\>=37w0d)
* Maternal age 18-64 years

Exclusion Criteria

* Multiparity
* History of prior uterine surgery such as cesarean section or myomectomy
* Unexplained vaginal bleeding
* Latex allergy
* Contraindication to vaginal delivery
* Pregestational or Gestational Diabetes
* Fetal growth restriction
* Fetus with suspected macrosomia
* Prematurity (\<37 weeks gestational age)
* Multiple gestation
* Refusal to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

Angela Bianco

OTHER

Sponsor Role lead

Responsible Party

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Angela Bianco

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Angela Bianco, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Eric Bergh, MD

Role: STUDY_DIRECTOR

Ichan School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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GCO 16-2121

Identifier Type: -

Identifier Source: org_study_id