The Role of Platelet Rich Plasma Towards the Repair of Pelvic Floor Muscle Damage in Primipara

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03021954
• Date of registration: 11/01/2017
• Prospective Registration: No
• Primary sponsor: Dr Cipto Mangunkusumo General Hospital
• Public title: The Role of Platelet Rich Plasma Towards the Repair of Pelvic Floor Muscle Damage in Primipara
• Scientific title: The Role of Platelet Rich Plasma Towards the Repair of Pelvic Floor Muscle Damage in Primipara
• Date of first enrolment: November 2016
• Target sample size: 90
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03021954
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Indonesia

Contacts

• Name: Fernandi Moegni

• Name: Fernandi Moegni, MD,OBGYN(C)
• Affiliation: FKUI/RSCM

• Name: Fernandi Moegni, MD,OBGYN(C)

Key inclusion & exclusion criteria

Inclusion Criteria:

- primigravida, in third trimester pregnancy

- plan to do vaginal birth

- 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



Age minimum: 20 Years
Age maximum: 35 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Pelvic Floor Disorders

Intervention(s)

Biological: Platelet Rich Plasma

Primary Outcome(s)

Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 40 days post partum [Time Frame: Third trimester and 40 days post partum]

Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 7 days post partum [Time Frame: Third trimester and 7 days post partum]

Change from baseline (third trimester) lower hiatal area during valsava measured using pelvic floor USG at 40 days post partum [Time Frame: Third trimester and 40 days post partum]

Change from baseline (third trimester) lower hiatal area measured using pelvic floor USG during valsava at 7 days post partum [Time Frame: Third trimester and 7 days post partum]

Change from baseline (third trimester) lower hiatal area during valsava measured using pelvic floor USG at 3 months post partum [Time Frame: Third trimester and 3 months post partum]

Pelvic Floor Muscle Contraction [Time Frame: Third trimester and 40 days post partum]

Pelvic Floor Muscle Contraction [Time Frame: Third trimester and 3 months post partum]

Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 3 months post partum [Time Frame: Third trimester and 3 months post partum]

Pelvic Floor Muscle Contraction [Time Frame: Third trimester and 7 days post partum]

Secondary Outcome(s)

Creatine Kinase [Time Frame: before labor, 24-48 hour post partum, and 7 days post partum]

IGF-1 [Time Frame: before labor, 24-48 hour post partum]

Pain [Time Frame: before labor, 7 days post partum, 40 days post partum, and 3 months post partum]

myoD [Time Frame: 7 days post partum]

Secondary ID(s)

DCiptoMGHFMoegni

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Indonesia University