Platelet Rich Plasma in Levator Ani Muscle Trauma

The Role of Platelet Rich Plasma in Supporting the Recovery of Post-partum Levator Ani Muscle Trauma

Levator trauma (ballooning) often occurs after vaginal delivery. Platelet rich plasma injection after delivery showed reduced hiatal area and maintain levator muscle strength.

Study Overview

• Status: Completed
• Conditions: Pelvic Floor Disorders
• Intervention / Treatment: Biological: Platelet Rich Plasma

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Fernandi Moegni, MD,OBGYN(C); Phone Number: +6282298111778; Email: fmoegni@yahoo.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia
      • Primary Care centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• primigravida, in third trimester pregnancy
• plan to do vaginal birth
• have a clear address and telephone number that can be contacted
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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 an autologous blood with high amount of platelet. It produced by obtaining patient's whole blood and processed by centrifugation and activation by CaCl2.; Other Names: PRP
No Intervention: Control Group; No intervention given, patient will only get local anesthesia injection before perineoraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

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

Collaborators and Investigators

• Sponsor: Dr Cipto Mangunkusumo General Hospital
• Collaborators: Indonesia University
• Investigators: Principal Investigator: Fernandi Moegni, MD,OBGYN(C), FKUI/RSCM

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimated): January 16, 2017

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: platelet rich plasma; levator ani muscle strength; levator ani muscle; post-partum trauma; ballooning trauma
• Additional Relevant MeSH Terms: Pregnancy Complications; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pelvic Floor Disorders
• Other Study ID Numbers: DCiptoMGHFMoegni

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO