LAS VEGAS — There was no difference in median pushing time for nulliparous women randomized to receive a dental support device, or a mouth-plate women could bite down on while pushing, in the second stage of labor, a researcher said here.
In an intention-to-treat analysis, the difference in median pushing time during second stage of labor between the group randomized to receive the device (LaboraideTM) and the control group was non-significant (84 minutes vs 92 minutes, P=0.11), reported Patricia Rekawek, MD, of Icahn School of Medicine at Mount Sinai in New York City.
At a presentation at the Society for Maternal-Fetal Medicine annual meeting, Rekawek noted prior research that found prolonged second stage of labor is associated with multiple maternal and neonatal complications, including increased rates of chorioamnionitis, third and fourth degree lacerations, and shoulder dystocia.
Co-author Angela Bianco, MD, also of Icahn, told MedPage Today that dental support devices are routinely used in other industries that require athletic performance, from professional athletes to people training on their own.
“There’s data from the exercise/physiology world that using a mouth-plate increases isometric force, and the work you can do,” she said.
Rekawek said at the presentation that previous studies using a dental support device to reduce the duration of labor in the second stage showed mixed results, with one pilot study from 2009 suggesting a significantly shorter second stage of labor with a dental support device, but “interpretation of results are limited by the small sample size.”
Researchers undertook a larger randomized trial, Dental Support Device in the Second Stage of Labor, with the goal of detecting a 20% difference in the duration of the second stage of labor in nulliparous women. Inclusion criteria included nulliparous women, non-anomalous fetus, singleton ≥37 weeks gestation and not yet in the second stage of labor.
Patients were considered enrolled when they reached full dilation, and those who consented to the trial had a sealed envelope containing randomization information placed in their room and opened immediately prior to pushing.
Overall, 346 patients reached full dilation, with 173 randomized to the intervention and 173 randomized to the control group. A large majority of both groups of patients were ages 18-34, and three-quarters were white. There were no differences between groups in other maternal factors, such as hypertensive disorders in labor, indications for admission or cervical dilation at admission.
There was no significant difference in median pushing time in the second stage for the intervention group versus controls, and there was also no difference between passive descent (median 14 minutes vs 13 minutes, respectively, P=0.22) and active pushing (50 vs 55, respectively, P=0.29) or other maternal or neonatal outcomes.
When examining the device usage time in the intervention group, 27% of patients said they used the device <50% of the time, and 6% said they used it 50%-100% of the time.
Bianco noted that 30% of women did not use the device 100% of the time, and said that future research could, “try and control for the amount of time the device was used, and try to achieve close to 100% usage in the second stage.”
She also noted that this study did not include multiparous women, so it would be interesting to examine usage of the device in this population in another study.
Limitations to the data included that patients and providers were not blinded to the intervention during pushing, and that the results may not be generalizable to a larger population of women outside this specific study criteria.
Finally, Rekawek presented this research on behalf of the first author, Eric Bergh, MD, also of Icahn, who had to leave the meeting when his wife went into labor the previous night.
“Her labor curve was phenomenal,” Rekawek said, but noted that Bergh’s wife did not use a dental support device.
The authors disclosed no relevant relationships with industry.