The Role of Platelet Rich Plasma Towards the Repair of Pelvic Floor Muscle Damage in Primipara

Study Overview
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Brief Summary
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This study aims to see if platelet rich plasma (PRP) have beneficial effect on the repair of pelvic floor muscle damage in primipara. Therefore, this double 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, and biomarker assessments.

Detailed Description
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This study aims to see if platelet rich plasma (PRP) has beneficial effect on the repair of pelvic floor muscle damage in primipara. Therefore, this double 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, and biomarker assessments. The ultrasonography outcome measures include lower hiatal area during contraction and during valsava. Menawhile, the biomarker assessments include Creatine Kinae, MyoD, and IGF-1. The assessments are performed at multiple time points, which are before labor, 24-48 hours post labor, 7 days post labor, 40 days post labor and 3 months post labor.

Official Title
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The Role of Platelet Rich Plasma Towards the Repair of Pelvic Floor Muscle Damage in Primipara

Conditions
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Pelvic Floor Disorders

Intervention / Treatment
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* Biological: Platelet Rich Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primigravida, in third trimester pregnancy plan to do vaginal birth 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet rich plasma<br>Platelet rich plasma injected intramuscularly in pelvic floor muscle immediately following labor and before perineoraphy, simultaneously with the injection of local anesthesia | Biological: Platelet Rich Plasma<br>* Platelet rich plasma is produced by obtaining patient's whole blood and processed by centrifugation and activation by CaCl2.<br>* Other names: PRP;|
| No Intervention: Control<br>No intervention given, patient will only get local anesthesia injection before perineoraphy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 7 days post partum | Assessed using pelvic floor USG | Third trimester and 7 days post partum | 
| Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 40 days post partum | Assessed using pelvic floor USG | Third trimester and 40 days post partum | 
| Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 3 months post partum | Assessed using pelvic floor USG | Third trimester and 3 months post partum | 
| Change from baseline (third trimester) lower hiatal area measured using pelvic floor USG during valsava at 7 days post partum | Assessed using pelvic floor USG | Third trimester and 7 days post partum | 
| Change from baseline (third trimester) lower hiatal area during valsava measured using pelvic floor USG at 40 days post partum | Assessed using pelvic floor USG | Third trimester and 40 days post partum | 
| Change from baseline (third trimester) lower hiatal area during valsava measured using pelvic floor USG at 3 months post partum | Assessed using pelvic floor USG | Third trimester and 3 months post partum | 
| Pelvic Floor Muscle Contraction | assessed using perineometry | Third trimester and 7 days post partum | 
| Pelvic Floor Muscle Contraction | assessed using perineometry | Third trimester and 40 days post partum | 
| Pelvic Floor Muscle Contraction | assessed using perineometry | Third trimester and 3 months post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatine Kinase | Assessed using appropriate reagent | before labor, 24-48 hour post partum, and 7 days post partum | 
| IGF-1 | Assessed using ELISA | before labor, 24-48 hour post partum | 
| myoD | Assessed using ELISA | 7 days post partum | 
| Pain | assessed using VAS | before labor, 7 days post partum, 40 days post partum, and 3 months post partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet rich plasma, pelvic floor disorders, primipara