Phase 3
N=116
Platelet Rich Plasma in Levator Ani Muscle Trauma
Pelvic Floor Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03021954 ↗Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Changes of Levator Hiatal Area During Valsava — 20.64; 20.35; 22.35; 21.41 Cm2 — p=0.086
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Platelet Rich Plasma (Biological)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
- Primary completion
- Jan 2019
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 |
Summary
Levator trauma (ballooning) often occurs after vaginal delivery. Platelet rich plasma injection after delivery showed reduced hiatal area and maintain levator muscle strength.
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.