Platelet Rich Plasma in Levator Ani Muscle Trauma

Phase 3CompletedNCT03021954

Dr Cipto Mangunkusumo General Hospital116 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

116

Conditions

Pelvic Floor Disorders

Interventions

Platelet Rich PlasmaBIOLOGICAL

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.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Primary Care Centre

Jakarta Pusat, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: Baseline (third trimester), 40 days post partum, and 3 months post partum

Data from ClinicalTrials.gov

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