Platelet Rich Plasma in Levator Ani Muscle Trauma

Dr Cipto Mangunkusumo General Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pelvic Floor Disorders

Treatments: Biological: Platelet Rich Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT03021954

DCiptoMGHFMoegni

Details and patient eligibility

About

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

Full 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.

Enrollment: 116 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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116 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Platelet rich plasma injected intramuscularly in pelvic floor muscle immediately following labor and before perineoraphy, simultaneously with the injection of local anesthesia

Treatment:

Biological: Platelet Rich Plasma

Control Group

No Intervention group

Description:

No intervention given, patient will only get local anesthesia injection before perineoraphy