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

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ClinicalTrials.gov Identifier: NCT03021954
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : January 16, 2017
Sponsor:
Collaborator:
Indonesia University
Information provided by (Responsible Party):
Fernandi Moegni, Dr Cipto Mangunkusumo General Hospital

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.

Condition or disease Intervention/treatment Phase
Pelvic Floor Disorders Biological: Platelet Rich Plasma Phase 2 Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Role of Platelet Rich Plasma Towards the Repair of Pelvic Floor Muscle Damage in Primipara
Study Start Date : November 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Platelet rich plasma
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
Platelet rich plasma is produced by obtaining patient's whole blood and processed by centrifugation and activation by CaCl2.
Other Name: PRP

No Intervention: Control
No intervention given, patient will only get local anesthesia injection before perineoraphy



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Pelvic Floor Muscle Contraction [ Time Frame: Third trimester and 7 days post partum ]
    assessed using perineometry

  8. Pelvic Floor Muscle Contraction [ Time Frame: Third trimester and 40 days post partum ]
    assessed using perineometry

  9. Pelvic Floor Muscle Contraction [ Time Frame: Third trimester and 3 months post partum ]
    assessed using perineometry


Secondary Outcome Measures :
  1. Creatine Kinase [ Time Frame: before labor, 24-48 hour post partum, and 7 days post partum ]
    Assessed using appropriate reagent

  2. IGF-1 [ Time Frame: before labor, 24-48 hour post partum ]
    Assessed using ELISA

  3. myoD [ Time Frame: 7 days post partum ]
    Assessed using ELISA

  4. Pain [ Time Frame: before labor, 7 days post partum, 40 days post partum, and 3 months post partum ]
    assessed using VAS



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021954


Contacts
Contact: Fernandi Moegni, MD,OBGYN(C) +6282298111778 fmoegni@yahoo.com

Locations
Indonesia
Primary Care Centre Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia
Contact: Fernandi Moegni    +6282298111778    fmoegni@yahoo.com   
Sponsors and Collaborators
Dr Cipto Mangunkusumo General Hospital
Indonesia University
Investigators
Principal Investigator: Fernandi Moegni, MD,OBGYN(C) FKUI/RSCM

Responsible Party: Fernandi Moegni, M.D., SpOG(K), Dr Cipto Mangunkusumo General Hospital
ClinicalTrials.gov Identifier: NCT03021954     History of Changes
Other Study ID Numbers: DCiptoMGHFMoegni
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fernandi Moegni, Dr Cipto Mangunkusumo General Hospital:
platelet rich plasma
pelvic floor disorders
primipara

Additional relevant MeSH terms:
Pelvic Floor Disorders
Pregnancy Complications