Trial Outcomes & Findings for Dental Support Device in the Second Stage of Labor (NCT NCT03138798)
NCT ID: NCT03138798
Last Updated: 2018-12-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
348 participants
Primary outcome timeframe
Up to 3 hours
Results posted on
2018-12-11
Participant Flow
Participant milestones
| Measure |
Laboraide TM Dental Support Device
Laboraide TM dental support device (a commercially available dental device made of soft plastic, 3 mm in thickness, which is inserted over the lower jaw with bite plates overlying the molar teeth) and were instructed to bite down on the dental support device (DSD) while pushing.
|
Control Group
no device
|
|---|---|---|
|
Overall Study
STARTED
|
173
|
175
|
|
Overall Study
Randomized But Did Not Meet Eligibility
|
6
|
4
|
|
Overall Study
COMPLETED
|
167
|
171
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only those participants who had an epidural were included
Baseline characteristics by cohort
| Measure |
Laboraide TM Dental Support Device
n=167 Participants
Laboraide TM dental support device
|
Control Group
n=171 Participants
No device
|
Total
n=338 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Maternal Age · 18-29 years
|
58 Participants
n=167 Participants
|
56 Participants
n=171 Participants
|
114 Participants
n=338 Participants
|
|
Age, Customized
Maternal Age · 30-34 years
|
73 Participants
n=167 Participants
|
83 Participants
n=171 Participants
|
156 Participants
n=338 Participants
|
|
Age, Customized
Maternal Age · 35-39 years
|
32 Participants
n=167 Participants
|
27 Participants
n=171 Participants
|
59 Participants
n=338 Participants
|
|
Age, Customized
Maternal Age · 40+ years
|
4 Participants
n=167 Participants
|
5 Participants
n=171 Participants
|
9 Participants
n=338 Participants
|
|
Age, Customized
Gestational Age at procedure · 37.0 - 38.9 weeks
|
31 Participants
n=167 Participants
|
34 Participants
n=171 Participants
|
65 Participants
n=338 Participants
|
|
Age, Customized
Gestational Age at procedure · 39.0 - 40.9 weeks
|
112 Participants
n=167 Participants
|
112 Participants
n=171 Participants
|
224 Participants
n=338 Participants
|
|
Age, Customized
Gestational Age at procedure · 41.0 - 41.9 weeks
|
24 Participants
n=167 Participants
|
25 Participants
n=171 Participants
|
49 Participants
n=338 Participants
|
|
Sex: Female, Male
Female
|
167 Participants
n=167 Participants
|
171 Participants
n=171 Participants
|
338 Participants
n=338 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=167 Participants
|
0 Participants
n=171 Participants
|
0 Participants
n=338 Participants
|
|
Race/Ethnicity, Customized
White
|
121 Participants
n=167 Participants
|
128 Participants
n=171 Participants
|
249 Participants
n=338 Participants
|
|
Race/Ethnicity, Customized
African American
|
8 Participants
n=167 Participants
|
7 Participants
n=171 Participants
|
15 Participants
n=338 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=167 Participants
|
14 Participants
n=171 Participants
|
24 Participants
n=338 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
18 Participants
n=167 Participants
|
19 Participants
n=171 Participants
|
37 Participants
n=338 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=167 Participants
|
3 Participants
n=171 Participants
|
13 Participants
n=338 Participants
|
|
BMI at delivery
18-29 kg/m2
|
126 Participants
n=167 Participants
|
127 Participants
n=171 Participants
|
253 Participants
n=338 Participants
|
|
BMI at delivery
30-39 kg/m2
|
35 Participants
n=167 Participants
|
43 Participants
n=171 Participants
|
78 Participants
n=338 Participants
|
|
BMI at delivery
40+ kg/m2
|
6 Participants
n=167 Participants
|
1 Participants
n=171 Participants
|
7 Participants
n=338 Participants
|
|
Preeclampsia with severe features on Magnesium
|
3 Participants
n=167 Participants
|
2 Participants
n=171 Participants
|
5 Participants
n=338 Participants
|
|
Indications for Admission
Labor induction (intact membranes)
|
42 Participants
n=167 Participants
|
43 Participants
n=171 Participants
|
85 Participants
n=338 Participants
|
|
Indications for Admission
Premature rupture of membranes (PROM)
|
31 Participants
n=167 Participants
|
31 Participants
n=171 Participants
|
62 Participants
n=338 Participants
|
|
Indications for Admission
Spontaneous Labor
|
94 Participants
n=167 Participants
|
97 Participants
n=171 Participants
|
191 Participants
n=338 Participants
|
|
Membrane Status
|
42 Participants
n=167 Participants
|
29 Participants
n=171 Participants
|
71 Participants
n=338 Participants
|
|
Meconium at ROM
|
20 Participants
n=167 Participants
|
30 Participants
n=171 Participants
|
50 Participants
n=338 Participants
|
|
Cervical dilation at admission >= 6 cm
|
12 Participants
n=167 Participants
|
7 Participants
n=171 Participants
|
19 Participants
n=338 Participants
|
|
Number of patients on pitocin in labor
|
110 Participants
n=167 Participants
|
122 Participants
n=171 Participants
|
232 Participants
n=338 Participants
|
|
Epidural
|
148 Participants
n=167 Participants
|
154 Participants
n=171 Participants
|
302 Participants
n=338 Participants
|
|
Number anesthetic boluses administered in 2nd stage
0
|
122 Participants
n=148 Participants • Only those participants who had an epidural were included
|
138 Participants
n=154 Participants • Only those participants who had an epidural were included
|
260 Participants
n=302 Participants • Only those participants who had an epidural were included
|
|
Number anesthetic boluses administered in 2nd stage
1
|
19 Participants
n=148 Participants • Only those participants who had an epidural were included
|
10 Participants
n=154 Participants • Only those participants who had an epidural were included
|
29 Participants
n=302 Participants • Only those participants who had an epidural were included
|
|
Number anesthetic boluses administered in 2nd stage
2
|
3 Participants
n=148 Participants • Only those participants who had an epidural were included
|
4 Participants
n=154 Participants • Only those participants who had an epidural were included
|
7 Participants
n=302 Participants • Only those participants who had an epidural were included
|
|
Number anesthetic boluses administered in 2nd stage
3
|
4 Participants
n=148 Participants • Only those participants who had an epidural were included
|
2 Participants
n=154 Participants • Only those participants who had an epidural were included
|
6 Participants
n=302 Participants • Only those participants who had an epidural were included
|
PRIMARY outcome
Timeframe: Up to 3 hoursPopulation: Only participants who delivered vaginally were included in the analysis
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.
Outcome measures
| Measure |
Laboraide TM Dental Support Device
n=161 Participants
Laboraide TM dental support device (a commercially available dental device made of soft plastic, 3 mm in thickness, which is inserted over the lower jaw with bite plates overlying the molar teeth) and were instructed to bite down on the DSD while pushing.
|
Control Group
n=161 Participants
No device
|
|---|---|---|
|
Dilation Duration of Second Stage of Labor Time
|
82 minutes
Interval 40.0 to 122.0
|
90 minutes
Interval 45.0 to 140.0
|
PRIMARY outcome
Timeframe: An average of 75 minutesPopulation: Only those participants who delivered vaginally were included in the analysis
The time from initiation of pushing until delivery during the second stage of labor. Intention to treat analysis will be performed.
Outcome measures
| Measure |
Laboraide TM Dental Support Device
n=161 Participants
Laboraide TM dental support device (a commercially available dental device made of soft plastic, 3 mm in thickness, which is inserted over the lower jaw with bite plates overlying the molar teeth) and were instructed to bite down on the DSD while pushing.
|
Control Group
n=161 Participants
No device
|
|---|---|---|
|
Delivery Time
|
46 minutes
Interval 23.0 to 80.0
|
53 minutes
Interval 26.0 to 86.0
|
SECONDARY outcome
Timeframe: Post-Op Day 1Population: Only those who participated in survey was included
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
Outcome measures
| Measure |
Laboraide TM Dental Support Device
n=124 Participants
Laboraide TM dental support device (a commercially available dental device made of soft plastic, 3 mm in thickness, which is inserted over the lower jaw with bite plates overlying the molar teeth) and were instructed to bite down on the DSD while pushing.
|
Control Group
No device
|
|---|---|---|
|
Dental Support Device Comfort and Patient Satisfaction
Was this device helpful? · Strongly disagree
|
10 Participants
|
—
|
|
Dental Support Device Comfort and Patient Satisfaction
Would you use the device again · Disagree
|
20 Participants
|
—
|
|
Dental Support Device Comfort and Patient Satisfaction
Was the device comfortable · Strongly disagree
|
11 Participants
|
—
|
|
Dental Support Device Comfort and Patient Satisfaction
Was the device comfortable · Disagree
|
15 Participants
|
—
|
|
Dental Support Device Comfort and Patient Satisfaction
Was the device comfortable · Neither agree nor disagree
|
15 Participants
|
—
|
|
Dental Support Device Comfort and Patient Satisfaction
Was the device comfortable · Agree
|
61 Participants
|
—
|
|
Dental Support Device Comfort and Patient Satisfaction
Was the device comfortable · Strongly agree
|
22 Participants
|
—
|
|
Dental Support Device Comfort and Patient Satisfaction
Was this device helpful? · Disagree
|
12 Participants
|
—
|
|
Dental Support Device Comfort and Patient Satisfaction
Was this device helpful? · Neither agree nor disagree
|
27 Participants
|
—
|
|
Dental Support Device Comfort and Patient Satisfaction
Was this device helpful? · Agree
|
46 Participants
|
—
|
|
Dental Support Device Comfort and Patient Satisfaction
Was this device helpful? · Strongly agree
|
29 Participants
|
—
|
|
Dental Support Device Comfort and Patient Satisfaction
Would you use the device again · Strongly disagree
|
10 Participants
|
—
|
|
Dental Support Device Comfort and Patient Satisfaction
Would you use the device again · Neither agree nor disagree
|
19 Participants
|
—
|
|
Dental Support Device Comfort and Patient Satisfaction
Would you use the device again · Agree
|
43 Participants
|
—
|
|
Dental Support Device Comfort and Patient Satisfaction
Would you use the device again · Strongly agree
|
32 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Delivery Outcomes: Mode of delivery
Outcome measures
| Measure |
Laboraide TM Dental Support Device
n=167 Participants
Laboraide TM dental support device (a commercially available dental device made of soft plastic, 3 mm in thickness, which is inserted over the lower jaw with bite plates overlying the molar teeth) and were instructed to bite down on the DSD while pushing.
|
Control Group
n=171 Participants
No device
|
|---|---|---|
|
Mode of Delivery
Normal spontaneous vaginal delivery (NSVD)
|
143 Participants
|
141 Participants
|
|
Mode of Delivery
Cesarean section
|
6 Participants
|
10 Participants
|
|
Mode of Delivery
Forcep delivery
|
11 Participants
|
13 Participants
|
|
Mode of Delivery
Vacuum delivery
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 1Estimated blood loss (EBL) during delivery
Outcome measures
| Measure |
Laboraide TM Dental Support Device
n=167 Participants
Laboraide TM dental support device (a commercially available dental device made of soft plastic, 3 mm in thickness, which is inserted over the lower jaw with bite plates overlying the molar teeth) and were instructed to bite down on the DSD while pushing.
|
Control Group
n=171 Participants
No device
|
|---|---|---|
|
Estimated Blood Loss
|
320 mL
Interval 221.0 to 400.0
|
350 mL
Interval 250.0 to 500.0
|
SECONDARY outcome
Timeframe: Day 1Number of participants with post-partum hemorrhage caused by uterine atony which is a loss of tone in the uterine musculature.
Outcome measures
| Measure |
Laboraide TM Dental Support Device
n=167 Participants
Laboraide TM dental support device (a commercially available dental device made of soft plastic, 3 mm in thickness, which is inserted over the lower jaw with bite plates overlying the molar teeth) and were instructed to bite down on the DSD while pushing.
|
Control Group
n=171 Participants
No device
|
|---|---|---|
|
Number of Participants With Post-partum Hemorrhage
|
19 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 1Chorioamnionitis - an intra-amniotic infection (IAI) is an inflammation of the fetal membranes (amnion and chorion) due to a bacterial infection.
Outcome measures
| Measure |
Laboraide TM Dental Support Device
n=167 Participants
Laboraide TM dental support device (a commercially available dental device made of soft plastic, 3 mm in thickness, which is inserted over the lower jaw with bite plates overlying the molar teeth) and were instructed to bite down on the DSD while pushing.
|
Control Group
n=171 Participants
No device
|
|---|---|---|
|
Number of Participants With Chorioamnionitis
|
8 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Day 1Neonatal outcomes - birth weight
Outcome measures
| Measure |
Laboraide TM Dental Support Device
n=167 Participants
Laboraide TM dental support device (a commercially available dental device made of soft plastic, 3 mm in thickness, which is inserted over the lower jaw with bite plates overlying the molar teeth) and were instructed to bite down on the DSD while pushing.
|
Control Group
n=171 Participants
No device
|
|---|---|---|
|
Neonatal Birth Weight
|
3343 grams
Standard Deviation 388
|
3286 grams
Standard Deviation 371
|
SECONDARY outcome
Timeframe: Day 1Neonatal outcomes - Number of male neonatal sex
Outcome measures
| Measure |
Laboraide TM Dental Support Device
n=167 Participants
Laboraide TM dental support device (a commercially available dental device made of soft plastic, 3 mm in thickness, which is inserted over the lower jaw with bite plates overlying the molar teeth) and were instructed to bite down on the DSD while pushing.
|
Control Group
n=171 Participants
No device
|
|---|---|---|
|
Neonatal Sex
|
85 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: Day 1Neonatal outcomes: Number of neonatal intensive care unit (NICU) admissions
Outcome measures
| Measure |
Laboraide TM Dental Support Device
n=167 Participants
Laboraide TM dental support device (a commercially available dental device made of soft plastic, 3 mm in thickness, which is inserted over the lower jaw with bite plates overlying the molar teeth) and were instructed to bite down on the DSD while pushing.
|
Control Group
n=171 Participants
No device
|
|---|---|---|
|
Number of NICU Admission
|
17 Participants
|
14 Participants
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Laboraide TM Dental Support Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place