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Dental Support Device in the Second Stage of Labor

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ClinicalTrials.gov Identifier: NCT03138798
Recruitment Status : Completed
First Posted : May 3, 2017
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Angela Bianco, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Labor Device: Laboraide TM dental support device Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dental Support Device in the Second Stage of Labor at a Major Tertiary Care Center; A Randomized Controlled Trial
Actual Study Start Date : January 6, 2017
Actual Primary Completion Date : November 7, 2017
Actual Study Completion Date : November 7, 2017

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.



Primary Outcome Measures :
  1. Dilation Duration of Second Stage of Labor Time [ Time Frame: Up to 3 hours ]
    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.

  2. Delivery Time [ Time Frame: An average of 75 minutes ]
    The time from initiation of pushing until delivery during the second stage of labor. Intention to treat analysis will be performed.


Secondary Outcome Measures :
  1. Dental Support Device Comfort and Patient Satisfaction [ Time Frame: Post-Op Day 1 ]
    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

  2. Mode of Delivery [ Time Frame: Day 1 ]
    Delivery Outcomes: Mode of delivery

  3. Estimated Blood Loss [ Time Frame: Day 1 ]
    Estimated blood loss (EBL) during delivery

  4. Number of Participants With Post-partum Hemorrhage [ Time Frame: Day 1 ]
    Number of participants with post-partum hemorrhage caused by uterine atony which is a loss of tone in the uterine musculature.

  5. Number of Participants With Chorioamnionitis [ Time Frame: Day 1 ]
    Chorioamnionitis - an intra-amniotic infection (IAI) is an inflammation of the fetal membranes (amnion and chorion) due to a bacterial infection.

  6. Neonatal Birth Weight [ Time Frame: Day 1 ]
    Neonatal outcomes - birth weight

  7. Neonatal Sex [ Time Frame: Day 1 ]
    Neonatal outcomes - Number of male neonatal sex

  8. Number of NICU Admission [ Time Frame: Day 1 ]
    Neonatal outcomes: Number of neonatal intensive care unit (NICU) admissions



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138798


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Angela Bianco
Icahn School of Medicine at Mount Sinai
Investigators
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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 Documents (Full-Text)

Documents provided by Angela Bianco, Icahn School of Medicine at Mount Sinai:

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Responsible Party: Angela Bianco, Director, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03138798     History of Changes
Other Study ID Numbers: GCO 16-2121
First Posted: May 3, 2017    Key Record Dates
Results First Posted: December 11, 2018
Last Update Posted: December 11, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Angela Bianco, Icahn School of Medicine at Mount Sinai:
Labor
Second stage
Dental device