Dental Support Device in the Second Stage of Labor

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

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 Overview

• Status: Completed
• Conditions: Labor
• Intervention / Treatment: Device: Laboraide TM dental support device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 348
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laboraide TM dental support device; Receive Laboraide	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.; Other Names: Dental Device; Dental Support Device
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental Support Device Comfort and Patient Satisfaction	After delivery patients assigned to the intervention group completed a comfort and satisfaction survey which consisted of three questions and given choices from strongly disagree to strongly agree	Post-Op Day 1
Mode of Delivery	Delivery Outcomes: Mode of delivery	Day 1
Estimated Blood Loss	Estimated blood loss (EBL) during delivery	Day 1
Number of Participants With Post-partum Hemorrhage	Number of participants with post-partum hemorrhage caused by uterine atony which is a loss of tone in the uterine musculature.	Day 1
Number of Participants With Chorioamnionitis	Chorioamnionitis - an intra-amniotic infection (IAI) is an inflammation of the fetal membranes (amnion and chorion) due to a bacterial infection.	Day 1
Neonatal Birth Weight	Neonatal outcomes - birth weight	Day 1
Neonatal Sex	Neonatal outcomes - Number of male neonatal sex	Day 1
Number of NICU Admission	Neonatal outcomes: Number of neonatal intensive care unit (NICU) admissions	Day 1

Collaborators and Investigators

• Sponsor: Angela Bianco
• Collaborators: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Angela Bianco, MD, Icahn School of Medicine at Mount Sinai; Study Director: Eric Bergh, MD, Ichan School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2017
• Primary Completion (Actual): November 7, 2017
• Study Completion (Actual): November 7, 2017

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 29, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2018
• Last Update Submitted That Met QC Criteria: November 16, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Labor; Second stage; Dental device
• Other Study ID Numbers: GCO 16-2121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes