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Platelet Rich Plasma in Levator Ani Muscle Trauma

NCT03021954 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2024-01-29

Study results available
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Summary

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

Conditions

  • Pelvic Floor Disorders

Interventions

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.

Sponsors & Collaborators

  • Indonesia University

    collaborator OTHER

  • Dr Cipto Mangunkusumo General Hospital

    lead OTHER

Principal Investigators

  • Fernandi Moegni, MD,OBGYN(C) · FKUI/RSCM

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-01-31
Completion
2020-01-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03021954 on ClinicalTrials.gov