Trial Outcomes & Findings for Platelet Rich Plasma in Levator Ani Muscle Trauma (NCT NCT03021954)
NCT ID: NCT03021954
Last Updated: 2024-01-29
Results Overview
Changes in lower hiatal area during valsalva in various measurements (compared to baseline value), measured using translabial 3D ultrasound. With the translabial technique at an angle of 70 degrees or more, the entire levator hiatus and surrounding muscles (pubococcygeus and puborectalis) can be visualized. It is hoped that ultrasound is more reproducible because axial measurements are easier with minimal dimensional images, at rest, valsalva, or contraction.
COMPLETED
PHASE2/PHASE3
116 participants
Baseline (third trimester), 40 days post-partum, 3 months post-partum
2024-01-29
Participant Flow
This study started in November 2016 until July 2019. We included all women who had a vaginal delivery in public health center (Puskesmas), and several referral hospitals. Minimal sampel size calculated for this study was 23 subjects each group, with 20 % additional for anticipating loss to follow up subjects. Therefore, minimal sample size was 29 each group.
We obtained 116 primigravid women. Fifty-three subjects were drop-out failed to finish the study. Five subjects were excluded from the study cause were detected having avulsion (macro trauma) injury at 40 days post-partum evaluation that was considered as severe degree of trauma and would made bias to the healing process. Finally, there were 58 subjects who successfully followed the examination until the end of the study.
Participant milestones
| Measure |
Platelet Rich Plasma
as many as 29 subjects were included in the intervention group. All of the subjects underwent PRP injection at levator ani muscle directly after vaginal delivery. Afterward, all of the subjects returned to control at 40 days post-partum for pelvic ultrasound examination assessing levator hiatal area and perineometry examination for assessing levator ani muscle strength. Then, the subject was asked to return at 3 months post-partum to perform a similar examination.
|
Lidocaine (Placebo)
as many as 29 subjects were included in the control group. All of the subjects underwent lidocaine 1% (placebo) injection at levator ani muscle directly after vaginal delivery. Afterward, all of the subjects returned to control at 40 days post-partum for pelvic ultrasound examination assessing levator hiatal area and perineometry examination for assessing levator ani muscle strength. Then, the subject was asked to return at 3 months post-partum to perform a similar examination.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
73
|
|
Overall Study
COMPLETED
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
14
|
44
|
Reasons for withdrawal
| Measure |
Platelet Rich Plasma
as many as 29 subjects were included in the intervention group. All of the subjects underwent PRP injection at levator ani muscle directly after vaginal delivery. Afterward, all of the subjects returned to control at 40 days post-partum for pelvic ultrasound examination assessing levator hiatal area and perineometry examination for assessing levator ani muscle strength. Then, the subject was asked to return at 3 months post-partum to perform a similar examination.
|
Lidocaine (Placebo)
as many as 29 subjects were included in the control group. All of the subjects underwent lidocaine 1% (placebo) injection at levator ani muscle directly after vaginal delivery. Afterward, all of the subjects returned to control at 40 days post-partum for pelvic ultrasound examination assessing levator hiatal area and perineometry examination for assessing levator ani muscle strength. Then, the subject was asked to return at 3 months post-partum to perform a similar examination.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
43
|
|
Overall Study
Subjects had avulsion trauma
|
4
|
1
|
Baseline Characteristics
Platelet Rich Plasma in Levator Ani Muscle Trauma
Baseline characteristics by cohort
| Measure |
Intervention
n=29 Participants
The intervention group receive a single dose of PRP that was produced from their own blood. We injected the PRP in the levator ani muscle when we did the perineorrhaphy procedure.
A baseline measurement was taken at the third trimester of pregnancy (when they come to do antenatal control). Then, we do a follow-up assessment at 40 weeks and three months post-partum.
|
Control
n=29 Participants
The control group only receive lidocaine (placebo) when we did the perineorrhaphy procedure.
A baseline measurement was taken at the third trimester of pregnancy (when they come to do antenatal control). Then, we do a follow-up assessment at 40 weeks and three months post-partum.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Levator Hiatal Area at Valsalva
|
20.64 cm2
n=93 Participants
|
20.35 cm2
n=4 Participants
|
20.37 cm2
n=27 Participants
|
|
Levator ani muscle strength
|
37.45 cmH2O
STANDARD_DEVIATION 13.89 • n=93 Participants
|
41.45 cmH2O
STANDARD_DEVIATION 18.05 • n=4 Participants
|
39.39 cmH2O
STANDARD_DEVIATION 16.09 • n=27 Participants
|
|
Baby birth weight
|
3042 gram
n=93 Participants
|
3100 gram
n=4 Participants
|
3100 gram
n=27 Participants
|
|
Age, Continuous
|
30.5 years
n=93 Participants
|
25 years
n=4 Participants
|
28.5 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
29 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline (third trimester), 40 days post-partum, 3 months post-partumChanges in lower hiatal area during valsalva in various measurements (compared to baseline value), measured using translabial 3D ultrasound. With the translabial technique at an angle of 70 degrees or more, the entire levator hiatus and surrounding muscles (pubococcygeus and puborectalis) can be visualized. It is hoped that ultrasound is more reproducible because axial measurements are easier with minimal dimensional images, at rest, valsalva, or contraction.
Outcome measures
| Measure |
Intervention
n=29 Participants
All intervention subjects underwent pelvic ultrasound examination for assessing levator hiatal area during valsalva at antenatal visit (baseline), 40 days post-partum, 3 months post-partum
|
Control
n=29 Participants
All control subjects underwent pelvic ultrasound examination for assessing levator hiatal area during valsalva at antenatal visit, 40 days post-partum, 3 months post-partum
|
|---|---|---|
|
Changes of Levator Hiatal Area During Valsava
Pre-intervention
|
20.64 Cm2
Interval 12.9 to 28.38
|
20.35 Cm2
Interval 14.78 to 25.92
|
|
Changes of Levator Hiatal Area During Valsava
40 days post-partum
|
22.35 Cm2
Interval 18.4 to 26.3
|
21.41 Cm2
Interval 15.14 to 27.68
|
|
Changes of Levator Hiatal Area During Valsava
3 months post-partum
|
17.57 Cm2
Interval 11.92 to 23.22
|
18.54 Cm2
Interval 9.56 to 27.5
|
PRIMARY outcome
Timeframe: Baseline (third trimester), 40 days post partum, and 3 months post partumChanges in pelvic floor muscle contraction in various measurements (compared to baseline), measured using perineometer
Outcome measures
| Measure |
Intervention
n=29 Participants
All intervention subjects underwent pelvic ultrasound examination for assessing levator hiatal area during valsalva at antenatal visit (baseline), 40 days post-partum, 3 months post-partum
|
Control
n=29 Participants
All control subjects underwent pelvic ultrasound examination for assessing levator hiatal area during valsalva at antenatal visit, 40 days post-partum, 3 months post-partum
|
|---|---|---|
|
Changes in Pelvic Floor Muscle Contraction
Pre-Intervention
|
37.45 CmH2O
Standard Deviation 13.89
|
41.45 CmH2O
Standard Deviation 18.05
|
|
Changes in Pelvic Floor Muscle Contraction
40 days post-partum
|
28.94 CmH2O
Standard Deviation 16.49
|
28.79 CmH2O
Standard Deviation 15.86
|
|
Changes in Pelvic Floor Muscle Contraction
3 months post-partum
|
35.84 CmH2O
Standard Deviation 18.81
|
30.88 CmH2O
Standard Deviation 18.33
|
Adverse Events
Intervention
Control
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