Pelvic Floor DisordersPhase 2/3NCT03021954
Platelet Rich Plasma in Levator Ani Muscle Trauma
A Phase 2/3 study testing Platelet Rich Plasma in people with Pelvic Floor Disorders, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial summary
Levator trauma (ballooning) often occurs after vaginal delivery. Platelet rich plasma injection after delivery showed reduced hiatal area and maintain levator muscle strength. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Platelet Rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteIndonesia
- Study dates
- Nov 2016to Jan 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- sepsis
- infection on perineum
- corticosteroid intake within last 2 weeks
- smoking
- hematopoetic or bone cancer
- delivery by c-section
- no perineoraphy after birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Platelet Rich Plasma in Supporting the Recovery of Post-partum Levator Ani Muscle Trauma
Levator trauma (ballooning) often occurs after vaginal delivery. Platelet rich plasma injection after delivery showed reduced hiatal area and maintain levator muscle strength.
Read the detailed 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.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Platelet Rich Plasma
- Keywords
- platelet rich plasma, levator ani muscle, post-partum trauma, ballooning trauma, levator ani muscle strength
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaBiological
Also called PRP
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Platelet rich plasma injected intramuscularly in pelvic floor muscle immediately following labor and before perineoraphy, simultaneously with the injection of local anesthesia Receives: Biological: Platelet Rich Plasma |
| Control Group | No intervention | No intervention given, patient will only get local anesthesia injection before perineoraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Levator Hiatal Area During Valsava
Changes in lower hiatal area during valsalva in various measurements (compared to baseline value), measured using translabial 3D ultrasound. With the translabial technique at an angle of 70 degrees or more, the entire levator hiatus and surrounding muscles (pubococcygeus and puborectalis) can be visualized. It is hoped that ultrasound is more reproducible because axial measurements are easier with minimal dimensional images, at rest, valsalva, or contraction.
Measured: Baseline (third trimester), 40 days post-partum, 3 months post-partum
Changes in Pelvic Floor Muscle Contraction
Changes in pelvic floor muscle contraction in various measurements (compared to baseline), measured using perineometer
Measured: Baseline (third trimester), 40 days post partum, and 3 months post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionJan 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Indonesia
- Responsible party
- Principal investigator, Fernandi Moegni, Dr Cipto Mangunkusumo General Hospital
- Investigators
- Fernandi Moegni, MD,OBGYN(C), Principal investigator, FKUI/RSCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021954
- Sponsor's protocol ID
- DCiptoMGHFMoegni
- Status last verified
- Jul 2023
- First submitted
- 11 Jan 2017
- Last updated
- 29 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Platelet Rich Plasma in Supporting the Recovery of Post-partum Levator Ani Muscle Trauma
- ClinicalTrials.gov ID
- NCT03021954
- Acronym / sponsor ID
- DCiptoMGHFMoegni
- Conditions
- Pelvic Floor Disorders
- Keywords
- platelet rich plasma, levator ani muscle, post-partum trauma, ballooning trauma, levator ani muscle strength
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Collaborators
- Universitas Indonesia
- Study start
- Nov 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Posted 29 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Levator trauma (ballooning) often occurs after vaginal delivery. Platelet rich plasma injection after delivery showed reduced hiatal area and maintain levator muscle strength.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Biological: Platelet Rich PlasmaPlatelet rich plasma injected intramuscularly in pelvic floor muscle immediately following labor and before perineoraphy, simultaneously with the injection of local anesthesia |
| Control Group | No intervention | –No intervention given, patient will only get local anesthesia injection before perineoraphy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- history of pelvic floor disorder before pregnancy
- history of pelvic surgery
- avulsion of levator ani muscle (seen in USG)
- unstable hemodynamic
- trombocytopenia (< 150,000)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich PlasmaAlso: PRPPlatelet 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. | Biological | Intervention Group |
Primary outcome
Changes of Levator Hiatal Area During Valsava
Time frame: Baseline (third trimester), 40 days post-partum, 3 months post-partum
Changes in lower hiatal area during valsalva in various measurements (compared to baseline value), measured using translabial 3D ultrasound. With the translabial technique at an angle of 70 degrees or more, the entire levator hiatus and surrounding muscles (pubococcygeus and puborectalis) can be visualized. It is hoped that ultrasound is more reproducible because axial measurements are easier with minimal dimensional images, at rest, valsalva, or contraction.
Changes in Pelvic Floor Muscle Contraction
Time frame: Baseline (third trimester), 40 days post partum, and 3 months post partum
Changes in pelvic floor muscle contraction in various measurements (compared to baseline), measured using perineometer
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernandi Moegni, MD,OBGYN(C) principal investigator
FKUI/RSCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Platelet Rich Plasma in people with Pelvic Floor Disorders, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Levator Hiatal Area During Valsava (time frame: Baseline (third trimester), 40 days post-partum, 3 months post-partum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.