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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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 Summary: 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.
Sponsor: Dr Cipto Mangunkusumo General Hospital

Current Primary Outcome:

  • Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 7 days post partum [ Time Frame: Third trimester and 7 days post partum ]
    Assessed using pelvic floor USG
  • Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 40 days post partum [ Time Frame: Third trimester and 40 days post partum ]
    Assessed using pelvic floor USG
  • Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 3 months post partum [ Time Frame: Third trimester and 3 months post partum ]
    Assessed using pelvic floor USG
  • Change from baseline (third trimester) lower hiatal area measured using pelvic floor USG during valsava at 7 days post partum [ Time Frame: Third trimester and 7 days post partum ]
    Assessed using pelvic floor USG
  • Change from baseline (third trimester) lower hiatal area during valsava measured using pelvic floor USG at 40 days post partum [ Time Frame: Third trimester and 40 days post partum ]
    Assessed using pelvic floor USG
  • Change from baseline (third trimester) lower hiatal area during valsava measured using pelvic floor USG at 3 months post partum [ Time Frame: Third trimester and 3 months post partum ]
    Assessed using pelvic floor USG


  • Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Creatine Kinase [ Time Frame: before labor, 24-48 hour post partum, and 7 days post partum ]
      Assessed using appropriate reagent
    • IGF-1 [ Time Frame: before labor, 24-48 hour post partum ]
      Assessed using ELISA
    • myoD [ Time Frame: 7 days post partum ]
      Assessed using ELISA
    • Pain [ Time Frame: before labor, 7 days post partum, 40 days post partum, and 3 months post partum ]
      assessed using VAS


    Original Secondary Outcome: Same as current

    Information By: Dr Cipto Mangunkusumo General Hospital

    Dates:
    Date Received: January 11, 2017
    Date Started: November 2016
    Date Completion: December 2017
    Last Updated: January 12, 2017
    Last Verified: January 2017