N/A
N=348
Dental Support Device in the Second Stage of Labor
Labor
Bottom Line
View on ClinicalTrials.gov: NCT03138798 ↗Enrolled (actual)
348
Serious AEs
—
Results posted
Dec 2018
Primary outcome: Primary: Dilation Duration of Second Stage of Labor Time — 82; 90 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laboraide TM dental support device (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Angela Bianco
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dilation Duration of Second Stage of Labor Time |
82; 90 | — |
| PRIMARY Delivery Time |
46; 53 | — |
| SECONDARY Dental Support Device Comfort and Patient Satisfaction |
11; 15; 15; 61; 22; 10 | — |
| SECONDARY Mode of Delivery |
143; 141; 11; 13; 7; 7 | — |
| SECONDARY Estimated Blood Loss |
320; 350 | — |
| SECONDARY Number of Participants With Post-partum Hemorrhage |
19; 12 | — |
| SECONDARY Number of Participants With Chorioamnionitis |
8; 16 | — |
| SECONDARY Neonatal Birth Weight |
3343; 3286 | — |
| SECONDARY Neonatal Sex |
85; 85 | — |
| SECONDARY Number of NICU Admission |
17; 14 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03138798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.