Trial Outcomes & Findings for Use of an Occlusal Support Device During the Second Stage of Labor (NCT NCT02807493)

NCT ID: NCT02807493

Last Updated: 2022-09-21

Results Overview

Determine if an Occlusal Support Device (OSD) can reduce the duration of the second stage of labor

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 347 participants
• Primary outcome timeframe: Duration of labor
• Results posted on: 2022-09-21

Participant Flow

Participant milestones

Measure	Occlusal Support Device Support device for women in labor Occlusal Support Device: Bite plate	Control No device given for women in labor Control: Control group
Overall Study STARTED	174	173
Overall Study COMPLETED	87	121
Overall Study NOT COMPLETED	87	52

Reasons for withdrawal

Measure	Occlusal Support Device Support device for women in labor Occlusal Support Device: Bite plate	Control No device given for women in labor Control: Control group
Overall Study Adverse Event	5	2
Overall Study Lost to Follow-up	6	0
Overall Study Physician Decision	4	1
Overall Study Protocol Violation	7	0
Overall Study Withdrawal by Subject	17	10
Overall Study Other withdrawal	17	0
Overall Study C-Section Prior to Stage 2 of Labor	31	39

Baseline Characteristics

Use of an Occlusal Support Device During the Second Stage of Labor

Baseline characteristics by cohort

Measure	Occlusal Support Device n=174 Participants Support device for women in labor Occlusal Support Device: Bite plate	Control n=173 Participants No device given for women in labor Control: Control group	Total n=347 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	174 Participants n=5 Participants	173 Participants n=7 Participants	347 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	174 Participants n=5 Participants	173 Participants n=7 Participants	347 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	134 Participants n=5 Participants	126 Participants n=7 Participants	260 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	16 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: Duration of labor

Determine if an Occlusal Support Device (OSD) can reduce the duration of the second stage of labor

Outcome measures

Measure	Occlusal Support Device n=75 Participants Support device for women in labor Occlusal Support Device: Bite plate	Control n=106 Participants No device given for women in labor Control: Control group
Stage 2 Duration of Labor	120.2 minutes Standard Deviation 88.2	107 minutes Standard Deviation 83.9

PRIMARY outcome

Timeframe: Baseline

Determine if an OSD can reduce the incidence of labor complications including Caesarian Sections

Outcome measures

Measure	Occlusal Support Device n=87 Participants Support device for women in labor Occlusal Support Device: Bite plate	Control n=121 Participants No device given for women in labor Control: Control group
Number of Participants With a Cesarian Section	12 participants	13 participants

PRIMARY outcome

Timeframe: at minute 1 and minute 5

Determine if the use of an OSD can improve Apgar scores in newborns. The Apgar test is done by a doctor, midwife, or nurse. The provider examines the baby's:

Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition. Higher scores are better. Scores are added for a total ranging from 0-10.

Outcome measures

Measure	Occlusal Support Device n=87 Participants Support device for women in labor Occlusal Support Device: Bite plate	Control n=121 Participants No device given for women in labor Control: Control group
Average Apgar Score APGAR at min 5	8.8 score on a scale Standard Deviation 0.5	8.8 score on a scale Standard Deviation 0.7
Average Apgar Score APGAR at min 1	7.8 score on a scale Standard Deviation 1.6	7.9 score on a scale Standard Deviation 1.4

Adverse Events

Occlusal Support Device

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Occlusal Support Device n=174 participants at risk Support device for women in labor Occlusal Support Device: Bite plate	Control n=173 participants at risk No device given for women in labor Control: Control group
Pregnancy, puerperium and perinatal conditions Miscarriage	2.9% 5/174 • Number of events 5 • Duration of labor	1.2% 2/173 • Number of events 2 • Duration of labor

Additional Information

James Gambucci

University of Minnesota

Phone: 612-625-7448

Email: gambu001@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place