Pelvic Floor Disorders
Conditions
Keywords
platelet rich plasma, levator ani muscle, post-partum trauma, ballooning trauma, levator ani muscle strength
Brief summary
Levator trauma (ballooning) often occurs after vaginal delivery. Platelet rich plasma injection after delivery showed reduced hiatal area and maintain levator muscle strength.
Detailed description
This study aims to see if PRP has a beneficial effect on the repair of pelvic floor muscle damage in primipara. Therefore, this single-blinded randomized clinical trial compares the pelvic floor muscle repair in primipara following labor between the interventional group who received intramuscular PRP injection in levator ani muscle and the control group, as assessed by ultrasonography, perineometry. The ultrasonography outcome measures include lower hiatal area during Valsalva. The assessments are performed at multiple time points, which are before labor, 24-48 hours post-labor, 40 days post-labor, and 3 months post-labor.
Interventions
BIOLOGICALPlatelet Rich Plasma
Platelet rich plasma is an autologous blood with high amount of platelet. It produced by obtaining patient's whole blood and processed by centrifugation and activation by CaCl2.
Sponsors
Indonesia University
Dr Cipto Mangunkusumo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* primigravida, in third trimester pregnancy * plan to do vaginal birth * have a clear address and telephone number that can be contacted * consent to participate in this study
Exclusion criteria
* history of pelvic floor disorder before pregnancy * history of pelvic surgery * avulsion of levator ani muscle (seen in USG) * unstable hemodynamic * trombocytopenia (\< 150,000) * anemia (Hb\< 10) * sepsis * infection on perineum * corticosteroid intake within last 2 weeks * smoking * hematopoetic or bone cancer * delivery by c-section * no perineoraphy after birth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Levator Hiatal Area During Valsava | Baseline (third trimester), 40 days post-partum, 3 months post-partum | 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. |
| Changes in Pelvic Floor Muscle Contraction | Baseline (third trimester), 40 days post partum, and 3 months post partum | Changes in pelvic floor muscle contraction in various measurements (compared to baseline), measured using perineometer |
Countries
Indonesia
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention 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. | 29 |
| Control 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. | 29 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 43 |
| Overall Study | Subjects had avulsion trauma | 4 | 1 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 30.5 years | 25 years | 28.5 years |
| Baby birth weight | 3042 gram | 3100 gram | 3100 gram |
| Levator ani muscle strength | 37.45 cmH2O STANDARD_DEVIATION 13.89 | 41.45 cmH2O STANDARD_DEVIATION 18.05 | 39.39 cmH2O STANDARD_DEVIATION 16.09 |
| Levator Hiatal Area at Valsalva | 20.64 cm2 | 20.35 cm2 | 20.37 cm2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 29 Participants | 29 Participants | 58 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 29 Participants | 29 Participants | 58 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
Primary
Changes in Pelvic Floor Muscle Contraction
Changes in pelvic floor muscle contraction in various measurements (compared to baseline), measured using perineometer
Time frame: Baseline (third trimester), 40 days post partum, and 3 months post partum
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Changes in Pelvic Floor Muscle Contraction | 40 days post-partum | 28.94 CmH2O | Standard Deviation 16.49 |
| Intervention | Changes in Pelvic Floor Muscle Contraction | Pre-Intervention | 37.45 CmH2O | Standard Deviation 13.89 |
| Intervention | Changes in Pelvic Floor Muscle Contraction | 3 months post-partum | 35.84 CmH2O | Standard Deviation 18.81 |
| Control | Changes in Pelvic Floor Muscle Contraction | 40 days post-partum | 28.79 CmH2O | Standard Deviation 15.86 |
| Control | Changes in Pelvic Floor Muscle Contraction | Pre-Intervention | 41.45 CmH2O | Standard Deviation 18.05 |
| Control | Changes in Pelvic Floor Muscle Contraction | 3 months post-partum | 30.88 CmH2O | Standard Deviation 18.33 |
Comparison: The null hypothesis is platelet rich plasma can maintain or increase levator ani muscle contractions post-partump-value: 0.29Wilcoxon (Mann-Whitney)
Primary
Changes of Levator Hiatal Area During Valsava
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.
Time frame: Baseline (third trimester), 40 days post-partum, 3 months post-partum
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Changes of Levator Hiatal Area During Valsava | Pre-intervention | 20.64 Cm2 |
| Intervention | Changes of Levator Hiatal Area During Valsava | 40 days post-partum | 22.35 Cm2 |
| Intervention | Changes of Levator Hiatal Area During Valsava | 3 months post-partum | 17.57 Cm2 |
| Control | Changes of Levator Hiatal Area During Valsava | Pre-intervention | 20.35 Cm2 |
| Control | Changes of Levator Hiatal Area During Valsava | 40 days post-partum | 21.41 Cm2 |
| Control | Changes of Levator Hiatal Area During Valsava | 3 months post-partum | 18.54 Cm2 |
Comparison: The null hypothesis is in the intervention group, we expect a decrease in the area of the levator hiatus at 40 days and 3 months post-partum. Power 90 % confidence interval β = 0.10, α = 0.05p-value: 0.086Wilcoxon (Mann-Whitney)