Platelet Rich Plasma in Levator Ani Muscle Trauma

Phase 2

Completed

• Conditions: Pelvic Floor Disorders
• Interventions: Biological: Platelet Rich Plasma

• Registration Number: NCT03021954
• Lead Sponsor: Dr Cipto Mangunkusumo General Hospital

Brief Summary

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

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 Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-16
• Primary Completion: 2019-01
• Study Completion: 2020-01
• Results First Submitted: 2022-03-22
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-06
• Last Update Submitted: 2023-07-06
• Results First Posted: 2024-01-29
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 116

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	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

Primary Outcome Measures

Name	Time	Method
Changes of Levator Hiatal Area During Valsava	Baseline (third trimester), 40 days post-partum, 3 months post-partum	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.
Changes in Pelvic Floor Muscle Contraction	Baseline (third trimester), 40 days post partum, and 3 months post partum	Changes in pelvic floor muscle contraction in various measurements (compared to baseline), measured using perineometer

Trial Locations

Locations (1)

Primary Care Centre; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia