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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
348
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.
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Dilation Duration of Second Stage of Labor Time
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.
Time frame: Up to 3 hours
Delivery Time
The time from initiation of pushing until delivery during the second stage of labor. Intention to treat analysis will be performed.
Time frame: An average of 75 minutes
Dental Support Device Comfort and Patient Satisfaction
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
Time frame: Post-Op Day 1
Mode of Delivery
Delivery Outcomes: Mode of delivery
Time frame: Day 1
Estimated Blood Loss
Estimated blood loss (EBL) during delivery
Time frame: Day 1
Number of Participants With Post-partum Hemorrhage
Number of participants with post-partum hemorrhage caused by uterine atony which is a loss of tone in the uterine musculature.
Time frame: Day 1
Number of Participants With Chorioamnionitis
Chorioamnionitis - an intra-amniotic infection (IAI) is an inflammation of the fetal membranes (amnion and chorion) due to a bacterial infection.
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Time frame: Day 1
Neonatal Birth Weight
Neonatal outcomes - birth weight
Time frame: Day 1
Neonatal Sex
Neonatal outcomes - Number of male neonatal sex
Time frame: Day 1
Number of NICU Admission
Neonatal outcomes: Number of neonatal intensive care unit (NICU) admissions
Time frame: Day 1