NCT03021954

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

January 29, 2024

Completed
Last Updated

January 29, 2024

Status Verified

July 1, 2023

Enrollment Period

2.2 years

First QC Date

January 11, 2017

Results QC Date

March 22, 2022

Last Update Submit

July 6, 2023

Conditions

Pelvic Floor Disorders

Keywords

platelet rich plasmalevator ani musclepost-partum traumaballooning traumalevator ani muscle strength

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    Baseline (third trimester), 40 days post partum, and 3 months post partum

Study Arms (2)

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

Biological: Platelet Rich Plasma

Control Group

NO INTERVENTION

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

Interventions

Platelet Rich PlasmaBIOLOGICAL

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.

Also known as: PRP
Intervention Group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Care Centre

Jakarta Pusat, DKI Jakarta, Indonesia

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Results Point of Contact

Title
dr. Fernandi Moegni
Organization
Dr Cipto Mangunkusumo Hospital
fernandi71@ui.ac.id
+62-82298111778

Study Officials

  • Fernandi Moegni, MD,OBGYN(C)

    FKUI/RSCM

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Obstetric and gynaecologist, Urogynaecologist

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 16, 2017

Study Start

November 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

January 29, 2024

Results First Posted

January 29, 2024

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)