Trial Outcomes & Findings for Safe Delivery Using a Belt on the Belly of Pregnant Woman (NCT NCT01566331)
NCT ID: NCT01566331
Last Updated: 2016-12-12
Results Overview
The following types of lacerations were recorded during delivery: cervical laceration; mild perineal lacerations (defined as 1-2 lacerations); severe perineal lacerations (defined as 3-4 lacerations)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
after delivery
Results posted on
2016-12-12
Participant Flow
Participant milestones
| Measure |
Baby-guardTM
Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes
Baby-guardTM: Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes
|
Baby-guardTM Minimal Inflation
Baby-guardTM with minimal inflation who expected natural delivery
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safe Delivery Using a Belt on the Belly of Pregnant Woman
Baseline characteristics by cohort
| Measure |
Baby-guardTM
n=40 Participants
Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes
|
Baby-guardTM With Minimal Inflation
n=40 Participants
Baby-guardTM system, with minimal inflation in women who expected natural delivery
|
Total
n=80 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
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.97 years
STANDARD_DEVIATION 5.16 • n=5 Participants
|
31.45 years
STANDARD_DEVIATION 1.2 • n=7 Participants
|
31.1 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after deliveryPopulation: intervention in normal pregnancies at term during labor and delivery
The following types of lacerations were recorded during delivery: cervical laceration; mild perineal lacerations (defined as 1-2 lacerations); severe perineal lacerations (defined as 3-4 lacerations)
Outcome measures
| Measure |
Baby Belt Device Group
n=40 Participants
|
Baby-guardTM With Minimal Inflation
n=40 Participants
|
|---|---|---|
|
Partecipant With Perineal Laceration
|
3 participants
|
31 participants
|
Adverse Events
Baby Birth
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Baby Birth With Minimal Inflation
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