Dental Support Device in the Second Stage of Labor

Labor Clinical Trial

Official title:

Dental Support Device in the Second Stage of Labor at a Major Tertiary Care Center; A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138798
• Other study ID #: GCO 16-2121
• Status: Completed
• Phase: N/A
• Start date: January 6, 2017
• Est. completion date: November 7, 2017

Study information

• Verified date: November 2018
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: November 7, 2017
• Est. primary completion date: November 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor

Intervention

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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Angela Bianco	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 3 hours
Primary	Delivery Time	The time from initiation of pushing until delivery during the second stage of labor. Intention to treat analysis will be performed.	An average of 75 minutes
Secondary	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	Post-Op Day 1
Secondary	Mode of Delivery	Delivery Outcomes: Mode of delivery	Day 1
Secondary	Estimated Blood Loss	Estimated blood loss (EBL) during delivery	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	Neonatal Birth Weight	Neonatal outcomes - birth weight	Day 1
Secondary	Neonatal Sex	Neonatal outcomes - Number of male neonatal sex	Day 1
Secondary	Number of NICU Admission	Neonatal outcomes: Number of neonatal intensive care unit (NICU) admissions	Day 1