Dental Support Device in the Second Stage of Labor

NCT03138798 | Completed Results FDA Device

• 1 other identifier: GCO 16-2121
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Labor; Second stage; Dental device

Outcome Measures

Primary Outcomes (2)

• Dilation Duration of Second Stage of Labor Time

  At the time of pushing in the second stage of labor, the time from full dilation to delivery during the second stage of labor in patients with vaginal delivery (spontaneous, vacuum, forceps included). Intention to treat analysis.

  Up to 3 hours

• Delivery Time

  The time from initiation of pushing until delivery during the second stage of labor. Intention to treat analysis will be performed.

  An average of 75 minutes

Secondary Outcomes (8)

• Dental Support Device Comfort and Patient Satisfaction

  Post-Op Day 1

• Mode of Delivery

  Day 1

• Estimated Blood Loss

  Day 1

• Number of Participants With Post-partum Hemorrhage

  Day 1

• Number of Participants With Chorioamnionitis

  Day 1

Study Arms (2)

Laboraide TM dental support device

EXPERIMENTAL

Receive Laboraide

Device: Laboraide TM dental support device

Control Group

NO INTERVENTION

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.

Interventions

Laboraide TM dental support device 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.

Also known as: Dental Device, Dental Support Device

Laboraide TM dental support device

Eligibility Criteria

• Age: 18 Years - 64 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Angela Bianco: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Interventions

Occlusal Splints

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Dr. Eric Bergh
• Organization: Icahn School of Medicine at Mount Sinai

eric.bergh@mssm.edu

908-625-8148

Study Officials

• Angela Bianco, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Eric Bergh, MD

  Ichan School of Medicine at Mount Sinai

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: May 3, 2017
• Study Start: January 6, 2017
• Primary Completion: November 7, 2017
• Study Completion: November 7, 2017
• Last Updated: December 11, 2018
• Results First Posted: December 11, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)