CompletedPhase 2/3

Platelet Rich Plasma in Levator Ani Muscle Trauma

Indonesia116 participantsStarted 2016-11

Plain-language summary

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

Who can participate

Age range20 Years – 40 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Changes of Levator Hiatal Area During Valsava

Timeframe: Baseline (third trimester), 40 days post-partum, 3 months post-partum

Changes in Pelvic Floor Muscle Contraction

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

Trial details

NCT IDNCT03021954

SponsorDr Cipto Mangunkusumo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01

Results submitted2022-03-22

View on ClinicalTrials.gov More Pelvic Floor Disorders trials