Platelet Rich Plasma in Levator Ani Muscle Trauma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pelvic Floor Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

Platelet Rich Plasma

Intervention Type BIOLOGICAL

Platelet rich plasma is an autologous blood with high amount of platelet. It produced by obtaining patient's whole blood and processed by centrifugation and activation by CaCl2.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Platelet Rich Plasma

Platelet rich plasma is an autologous blood with high amount of platelet. It produced by obtaining patient's whole blood and processed by centrifugation and activation by CaCl2.

Intervention Type BIOLOGICAL

Other Intervention Names

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PRP

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes