NCT03138798

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 348 (actual)
• Sponsor: Angela Bianco · Academic / Other
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Labor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-06
• Primary completion: 2017-11-07
• Completion: 2017-11-07
• First posted: 2017-05-03
• Last updated: 2018-12-11
• Results posted: 2018-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study