Clinical trial NCT03138798: Dental Support Device in the Second Stage of Labor
Official title: Dental Support Device in the Second Stage of Labor at a Major Tertiary Care Center; A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor
Keywords: Labor
Second stage
Dental device
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2017-05-03
Enrollment: 348
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Dilation Duration of Second Stage of Labor Time
timeFrame: Up to 3 hours
measure: Delivery Time
timeFrame: An average of 75 minutes
Secondary outcomes:
measure: Dental Support Device Comfort and Patient Satisfaction
timeFrame: Post-Op Day 1
measure: Mode of Delivery
timeFrame: Day 1
measure: Estimated Blood Loss
timeFrame: Day 1
measure: Number of Participants With Post-partum Hemorrhage
timeFrame: Day 1
measure: Number of Participants With Chorioamnionitis
timeFrame: Day 1
measure: Neonatal Birth Weight
timeFrame: Day 1
measure: Neonatal Sex
timeFrame: Day 1
measure: Number of NICU Admission
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Angela Bianco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ichan School of Medicine at Mount Sinai
name: Eric Bergh, MD
role: STUDY_DIRECTOR
References: