The Role of Platelet Rich Plasma Towards the Repair of Pelvic Floor Muscle Damage in Primipara
Primary Purpose
Pelvic Floor Disorders
Status
Unknown status
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
Platelet Rich Plasma
Sponsored by
About this trial
This is an interventional prevention trial for Pelvic Floor Disorders focused on measuring platelet rich plasma, pelvic floor disorders, primipara
Eligibility 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
Sites / Locations
- Primary Care CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Platelet rich plasma
Control
Arm Description
Platelet rich plasma injected intramuscularly in pelvic floor muscle immediately following labor and before perineoraphy, simultaneously with the injection of local anesthesia
No intervention given, patient will only get local anesthesia injection before perineoraphy
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
Pelvic Floor Muscle Contraction
assessed using perineometry
Pelvic Floor Muscle Contraction
assessed using perineometry
Pelvic Floor Muscle Contraction
assessed using perineometry
Secondary Outcome Measures
Creatine Kinase
Assessed using appropriate reagent
IGF-1
Assessed using ELISA
myoD
Assessed using ELISA
Pain
assessed using VAS
Full Information
NCT ID
NCT03021954
First Posted
January 11, 2017
Last Updated
January 12, 2017
Sponsor
Dr Cipto Mangunkusumo General Hospital
Collaborators
Indonesia University
1. Study Identification
Unique Protocol Identification Number
NCT03021954
Brief Title
The Role of Platelet Rich Plasma Towards the Repair of Pelvic Floor Muscle Damage in Primipara
Official Title
The Role of Platelet Rich Plasma Towards the Repair of Pelvic Floor Muscle Damage in Primipara
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr Cipto Mangunkusumo General Hospital
Collaborators
Indonesia University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders
Keywords
platelet rich plasma, pelvic floor disorders, primipara
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Platelet rich plasma
Arm Type
Experimental
Arm Description
Platelet rich plasma injected intramuscularly in pelvic floor muscle immediately following labor and before perineoraphy, simultaneously with the injection of local anesthesia
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention given, patient will only get local anesthesia injection before perineoraphy
Intervention Type
Biological
Intervention Name(s)
Platelet Rich Plasma
Other Intervention Name(s)
PRP
Intervention Description
Platelet rich plasma is produced by obtaining patient's whole blood and processed by centrifugation and activation by CaCl2.
Primary Outcome Measure Information:
Title
Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 7 days post partum
Description
Assessed using pelvic floor USG
Time Frame
Third trimester and 7 days post partum
Title
Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 40 days post partum
Description
Assessed using pelvic floor USG
Time Frame
Third trimester and 40 days post partum
Title
Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 3 months post partum
Description
Assessed using pelvic floor USG
Time Frame
Third trimester and 3 months post partum
Title
Change from baseline (third trimester) lower hiatal area measured using pelvic floor USG during valsava at 7 days post partum
Description
Assessed using pelvic floor USG
Time Frame
Third trimester and 7 days post partum
Title
Change from baseline (third trimester) lower hiatal area during valsava measured using pelvic floor USG at 40 days post partum
Description
Assessed using pelvic floor USG
Time Frame
Third trimester and 40 days post partum
Title
Change from baseline (third trimester) lower hiatal area during valsava measured using pelvic floor USG at 3 months post partum
Description
Assessed using pelvic floor USG
Time Frame
Third trimester and 3 months post partum
Title
Pelvic Floor Muscle Contraction
Description
assessed using perineometry
Time Frame
Third trimester and 7 days post partum
Title
Pelvic Floor Muscle Contraction
Description
assessed using perineometry
Time Frame
Third trimester and 40 days post partum
Title
Pelvic Floor Muscle Contraction
Description
assessed using perineometry
Time Frame
Third trimester and 3 months post partum
Secondary Outcome Measure Information:
Title
Creatine Kinase
Description
Assessed using appropriate reagent
Time Frame
before labor, 24-48 hour post partum, and 7 days post partum
Title
IGF-1
Description
Assessed using ELISA
Time Frame
before labor, 24-48 hour post partum
Title
myoD
Description
Assessed using ELISA
Time Frame
7 days post partum
Title
Pain
Description
assessed using VAS
Time Frame
before labor, 7 days post partum, 40 days post partum, and 3 months post partum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernandi Moegni, MD,OBGYN(C)
Phone
+6282298111778
Email
fmoegni@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernandi Moegni, MD,OBGYN(C)
Organizational Affiliation
FKUI/RSCM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Care Centre
City
Jakarta Pusat
State/Province
DKI Jakarta
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernandi Moegni
Phone
+6282298111778
Email
fmoegni@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
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The Role of Platelet Rich Plasma Towards the Repair of Pelvic Floor Muscle Damage in Primipara
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