Platelet Rich Plasma in Levator Ani Muscle Trauma

Pelvic Floor Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021954
• Other study ID #: DCiptoMGHFMoegni
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2016
• Est. completion date: January 2020

Study information

• Verified date: July 2023
• Source: Dr Cipto Mangunkusumo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: January 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor Disorders

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Primary Care Centre	Jakarta Pusat	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Dr Cipto Mangunkusumo General Hospital	Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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