Dental Support Device in the Second Stage of Labor

Completed · Not applicable

Conditions studied: Labor

In brief

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.

Key facts

Study ID

NCT03138798

Run by

Angela Bianco

People needed

348

Starts

2017-01-06

Expected to finish

2017-11-07

Last updated by the study team

2018-12-11

Who can join

Age: 18 and older, up to 64. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Nulliparous women
• Non-anomalous fetus
• Singleton fetus
• Vertex presentation
• In the first phase of labor
• Full term gestation (>=37w0d)
• Maternal age 18-64 years

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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