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Completed

NCT Number: NCT03138798

Dental Support Device in the Second Stage of Labor

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.

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Key information

Conditions

Labor

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Dental Device, Dental Support Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Angela Bianco

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 3, 2017
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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