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Mouth Guard Use in the Second Stage of Labor
NCT03520530 · View on ClinicalTrials.gov ↗
Study Summary
Shortening the second stage of labor, the time spent pushing the baby out, is important for positive mother and infant's outcomes. Lack of progress of labor for any reason is the most common reason for cesarean section in women having their first baby and the second most common reason for cesarean section in women who have already had a baby. In 2014, a large study done across the United States showed increases in complications in both mother and infant when pushing was prolonged, including uterine infection, postpartum hemorrhage, more extensive vaginal tearing, shoulder dystocia, 5 minute Apgar score less than 4, infant admission to Neonatal Intensive Care Unit and neonatal infections. Therefore, the challenge is to consider alternative practices in order to maximize a mother's chance of a vaginal delivery and minimize these associated risks to both mother and baby. Mouth guards are used primarily in contact sports, and have been demonstrated to reduce or prevent injury to the teeth. Additionally, it has been proposed that wearing a mouth guard increases the strength of different muscle groups. A recent randomized controlled pilot study including women with their first pregnancy using a dental support device (DSD) during the second stage of labor evaluated the length of the second stage and outcomes. They found a significant decrease of 38% in the length of pushing time in the group that used a DSD. Additionally, there was a decreased rate of cesarean section in this group, however a p-value was not reported. This study only included 64 patients. A second, larger trial did not find a significant difference in pushing time, however the rate of interventions such as a vacuum or forceps-assisted vaginal delivery and cesarean section were much higher in the control group due to prolonged pushing. The results of the second study are contradictory in nature, yet the researchers do not provide hypotheses into why this may be. It is clear from the previously mentioned s
Conditions Studied
Interventions
- DEVICE Mouth Guard
Study Locations (1)
Delaware
- Christiana Care Health System — Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2018-05-09 |
| Est. Completion | 2019-12-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03520530
The ClinicalTrials.gov registry entry for NCT03520530 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Christiana Care Health Services, which has 50 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Labor Long appearing as the primary indexed condition, and to 1 intervention — of which Mouth Guard is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03520530 reports 1 study location spanning 1 distinct geographic area — top geographies include Delaware. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03520530 about?
NCT03520530 is a clinical study titled "Mouth Guard Use in the Second Stage of Labor". Shortening the second stage of labor, the time spent pushing the baby out, is important for positive mother and infant's outcomes. Lack of progress of labor for any reason is the most common reason for cesarean section in women having their first baby and the second most common reason for cesarean s...
What is the current status of trial NCT03520530?
This trial is currently completed. It is a NA study. The enrollment target is 154 participants. The study started on 2018-05-09. Estimated completion is 2019-12-01.
What conditions does trial NCT03520530 study?
This clinical trial studies the following conditions: Labor Long, Dystocia; Fetal, Cesarean Section, Affecting Fetus or Newborn. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03520530?
The interventions under investigation include: Mouth Guard (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03520530?
This trial is sponsored by Christiana Care Health Services, which has 50 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03520530 being conducted?
This trial has 1 study location across Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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