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Completed

NCT Number: NCT03021954

Platelet Rich Plasma in 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.

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Key information

Conditions

Pelvic Floor Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pregnancy Complications Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Primary Care Centre

Jakarta Pusat, DKI Jakarta, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet rich plasma

Biological

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

Primary outcomes

  1. Changes of Levator Hiatal Area During Valsava

    Time frame: 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.

  2. Changes in Pelvic Floor Muscle Contraction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Dr Cipto Mangunkusumo General Hospital

Other

Collaborators

  • Indonesia University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jan 16, 2017
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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