Dental Support Device in the Second Stage of Labor

Angela Bianco

Status: Completed

Conditions: Labor

Treatments: Device: Laboraide TM dental support device

Study type: Interventional

Funder types: Other

Identifiers

NCT03138798

GCO 16-2121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 348 patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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348 participants in 2 patient groups

Laboraide TM dental support device

Experimental group

Description:

Receive Laboraide

Treatment:

Device: Laboraide TM dental support device

Control Group

No Intervention group

Description:

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.