Phase 3
Completed N=116
Platelet Rich Plasma in Levator Ani Muscle Trauma
Pelvic Floor Disorders
Source: ClinicalTrials.gov NCT03021954 ↗
Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Changes of Levator Hiatal Area During Valsava — 20.64; 20.35; 22.35; 21.41 Cm2 — p=0.086
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Levator trauma (ballooning) often occurs after vaginal delivery. Platelet rich plasma injection after delivery showed reduced hiatal area and maintain levator muscle strength.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes of Levator Hiatal Area During Valsava |
20.64; 20.35; 22.35; 21.41; 17.57; 18.54 | 0.086 |
| PRIMARY Changes in Pelvic Floor Muscle Contraction |
37.45; 41.45; 28.94; 28.79; 35.84; 30.88 | 0.29 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03021954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.