Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Indonesia University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Levator trauma (ballooning) often occurs after vaginal delivery. Platelet rich plasma injection after delivery showed reduced hiatal area and maintain levator muscle strength.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Platelet rich plasma injected intramuscularly in pelvic floor muscle immediately following labor and before perineoraphy, simultaneously with the injection of local anesthesia |
|
| Control Group | No Intervention | No intervention given, patient will only get local anesthesia injection before perineoraphy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (third trimester), 40 days post-partum, 3 months post-partum |
| Changes in Pelvic Floor Muscle Contraction | Changes in pelvic floor muscle contraction in various measurements (compared to baseline), measured using perineometer | Baseline (third trimester), 40 days post partum, and 3 months post partum |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fernandi Moegni, MD,OBGYN(C) | FKUI/RSCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Care Centre | Jakarta Pusat | DKI Jakarta | Indonesia |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | Cm2 | Baseline (third trimester), 40 days post-partum, 3 months post-partum |
|
3 months
The intervention procedure in this study is platelet rich plasma injection at levator ani muscle during the during perineorraphy after childbirth which is a normal procedure of labor. Treatment was carried out according to the post-partum care protocol, so incidence of infection can be avoided.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | We collect adverse events by asking the subject and physical examination (especially site of injection) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| dr. Fernandi Moegni | Dr Cipto Mangunkusumo Hospital | +62-82298111778 | fernandi71@ui.ac.id |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 15, 2018 | Jul 25, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 15, 2018 | Jul 25, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 15, 2018 | Jul 25, 2022 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Levator Hiatal Area at Valsalva | Median | Inter-Quartile Range | cm2 |
|
| Levator ani muscle strength | Mean | Standard Deviation | cmH2O |
|
| Baby birth weight | Median | Inter-Quartile Range | gram |
|
| Control |
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 |
|
|
|
| Primary | Changes in Pelvic Floor Muscle Contraction | Changes in pelvic floor muscle contraction in various measurements (compared to baseline), measured using perineometer | Posted | Mean | Standard Deviation | CmH2O | Baseline (third trimester), 40 days post partum, and 3 months post partum |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Control | No different collection method with the intervention group | 0 | 29 | 0 | 29 | 0 | 29 |
Not provided
Not provided
| D052801 | Male Urogenital Diseases |
| 3 months post-partum |
|