Platelet Rich Plasma for Uterine Scar (AA-PRP)
Primary Purpose
Cesarean Section Complications, Uterine Bleeding, Pelvic Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Platelet Rich Plasma
Sponsored by
About this trial
This is an interventional prevention trial for Cesarean Section Complications focused on measuring uterine scar defect, cesarean delivery, pelvic pain, spotting, niche, cesarean section complication, uterine scar, Platelet Rich Plasma (PRP)
Eligibility Criteria
Inclusion criteria:
Study group A:
- Women undergoing elective cesarean delivery
- Term pregnancy (≥37 weeks of gestation)
- Singleton pregnancy
Study group B:
- Women undergoing niche (uterine scar defect) repair
Exclusion criteria:
- Thrombocytopenia (CBC Platelet count <70,000)
- Connective tissue disease
- Uterine scars other than cesarean (s/p myomectomy, s/p cornual resection)
- Malformed uterus (unicornuate, bicornuate, didelphic)
- Pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PRP Treatment
Control
Arm Description
PRP preparation will be applied on uterine incision after its closure.
Normal Cesarean delivery stages.
Outcomes
Primary Outcome Measures
Residual myometrial thickness
Residual myometrial thickness at the uterine scar (mm)
Secondary Outcome Measures
Residual myometrial thickness/Adjacent myometrial thickness
Ratio between adjacent and residual myometrial thickness
Niche depth
Niche depth (mm)
Niche length
Niche length (mm)
Full Information
NCT ID
NCT05224726
First Posted
January 25, 2022
Last Updated
May 18, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT05224726
Brief Title
Platelet Rich Plasma for Uterine Scar
Acronym
AA-PRP
Official Title
Platelet Rich Plasma for the Treatment of Uterine Scar
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
When vessel wall injury occurs, platelets become activated, releasing more than 30 bioactive proteins, many of which have a fundamental role in hemostasis, inflammation and ultimate wound healing. Platelet-rich plasma (PRP), a modification of fibrin glue made from autologous blood, is being used to deliver growth factors in high concentration to sites requiring wound healing. PRP is obtained from a sample of patients' blood drawn at the time of treatment. As the rate of cesarean deliveries has been rising, long-term adverse sequelae due to uterine scar defects have been increasing. PRP might be a simple preventive treatment that potentially can reduce morbidity following cesarean deliveries.
Detailed Description
Introduction Platelets are cytoplasmic fragments of megakaryocytes, formed in the marrow and approximately 2 μm in diameter. When vessel wall injury occurs, they become activated, releasing more than 30 bioactive proteins, many of which have a fundamental role in hemostasis, inflammation and ultimate wound healing. Growth factors released from the platelets include platelet-derived growth factor, transforming growth factor beta, platelet-derived epidermal growth factor, platelet-derived angiogenesis factor, insulin-like growth factor 1, and platelet factor 4. These factors signal the local mesenchymal and epithelial cells to migrate, divide, and increase collagen and matrix synthesis.
Platelet-rich plasma (PRP), a modification of fibrin glue made from autologous blood, is being used to deliver growth factors in high concentration to sites requiring wound healing. Its clinical uses have dramatically increased in the last decade in various fields of medicine including orthopedics, cardiothoracic surgery, plastic surgery, dermatology, dentistry, and diabetic wound healing. Recently, its positive effects in promoting endometrial and follicular growth and gestation in assisted reproduction cycles have also been demonstrated.
PRP is obtained from a sample of patients' blood drawn at the time of treatment. A 30cc venous blood draw will yield 3-5 cc of PRP depending on the baseline platelet count of an individual, the device used, and the technique employed. The blood draw occurs with the addition of an anticoagulant, such as citrate dextrose A to prevent platelet activation prior to its use. The preparation process is known as differential centrifugation. An initial centrifugation to separate red blood cells (RBC) is followed by a second centrifugation to concentrate platelets, which are suspended in the smallest final plasma volume. The upper 2/3 portion of the volume that is composed mostly of platelet-poor plasma (PPP) is removed. Pellets are homogenized in lower 1/3rd (5 ml of plasma) to create the Platelet-Rich Plasma (PRP). A count of 1 million /mL has become the working definition for therapeutic PRP. Activation of the platelets before their application is not required as there is no consensus for better results.
Caesarean delivery is the commonest operation performed on women worldwide with progressively rising incidence. Consequently, long-term adverse sequelae due to uterine scar defect have been increasing. Common gynecological complains include chronic pelvic pain, dyspareunia, dysmenorrhea and postmenstrual spotting and infertility. Obstetric sequelae seem to be increasing such as cesarean scar ectopic pregnancy, placenta previa, and placenta accrete, all associated with major maternal morbidity and even mortality. Given the association between uterine scar defect and gynecological symptoms, obstetric complications and potentially subfertility, it is important to develop preventive strategies.
To the best of knowledge studies using PRP for uterine scars treatment have not been published. Due to the aforementioned, the aim of our study is to learn the effect of PRP use on uterine scar healing.
Material and Methods This is a prospective randomized single blinded study that will be conducted in a single tertiary medical center. Study population will include: A. women planned to undergo elective cesarean delivery at term with singleton pregnancy; and B. women undergoing uterine scar repair due to uterine scar defect following cesarean delivery. Women meeting inclusion criteria will be offered to participate in the study. After signing informed consent, block randomization will be separately completed for each study population for one of two groups: A- administration of PRP following uterine incision repair, B - no administration of PRP on the uterine incision. Women will be blinded to the group they have been randomized to. Blood will be drawn to all women 30 minutes before operation for platelet count and preparation of PRP (in case randomization was for group A). All operations will be performed by highly skilled surgeons of the same team. All other stages of operations will be similar in both of the groups. Operative and post-operative data will be collected from the medical files including: operation duration, estimated blood loss, operation complications (hypotension, bladder gut or vascular perforation), post-operative complications (hemorrhage, endometritis, vascular - thromboembolic event, ileus). All women will be invited to the gynecologic clinics six months post operation for trans-vaginal sonographic evaluation of the uterine scar. Measurement will include uterine scar residual myometrial thickness (RMT), adjacent myometrial thickness (AMT), depth, length, and RMT/AMT ratio.
Women's reports regarding possibility of uterine scar defect symptoms (heavy menstrual bleeding, intermenstrual spotting, pelvic pain) will additionally be collected on follow-up visit
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications, Uterine Bleeding, Pelvic Pain, Menstrual Irregularity
Keywords
uterine scar defect, cesarean delivery, pelvic pain, spotting, niche, cesarean section complication, uterine scar, Platelet Rich Plasma (PRP)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control study
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRP Treatment
Arm Type
Experimental
Arm Description
PRP preparation will be applied on uterine incision after its closure.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Normal Cesarean delivery stages.
Intervention Type
Other
Intervention Name(s)
Platelet Rich Plasma
Intervention Description
Applying 5cc of PRP preparation on uterine incision after it has been sutured.
Primary Outcome Measure Information:
Title
Residual myometrial thickness
Description
Residual myometrial thickness at the uterine scar (mm)
Time Frame
6 months after cesarean delivery
Secondary Outcome Measure Information:
Title
Residual myometrial thickness/Adjacent myometrial thickness
Description
Ratio between adjacent and residual myometrial thickness
Time Frame
6 months after cesarean delivery
Title
Niche depth
Description
Niche depth (mm)
Time Frame
6 months after cesarean delivery
Title
Niche length
Description
Niche length (mm)
Time Frame
6 months after cesarean delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Study group A:
Women undergoing elective cesarean delivery
Term pregnancy (≥37 weeks of gestation)
Singleton pregnancy
Study group B:
- Women undergoing niche (uterine scar defect) repair
Exclusion criteria:
Thrombocytopenia (CBC Platelet count <70,000)
Connective tissue disease
Uterine scars other than cesarean (s/p myomectomy, s/p cornual resection)
Malformed uterus (unicornuate, bicornuate, didelphic)
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aya Mohr-Sasson, M.D
Phone
3462704682
Email
aya.mohrsasson@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25722595
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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PubMed Identifier
33723748
Citation
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Results Reference
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PubMed Identifier
33299482
Citation
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Results Reference
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PubMed Identifier
34733236
Citation
Lin Y, Qi J, Sun Y. Platelet-Rich Plasma as a Potential New Strategy in the Endometrium Treatment in Assisted Reproductive Technology. Front Endocrinol (Lausanne). 2021 Oct 18;12:707584. doi: 10.3389/fendo.2021.707584. eCollection 2021.
Results Reference
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PubMed Identifier
34415119
Citation
Ferrari AR, Cortrezzi S, Borges E Junior, Braga D, Souza MDCB, Antunes RA. Evaluation of the Effects of Platelet-Rich Plasma on Follicular and Endometrial Growth: A Literature Review. JBRA Assist Reprod. 2021 Oct 4;25(4):601-607. doi: 10.5935/1518-0557.20210036.
Results Reference
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PubMed Identifier
32700285
Citation
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Citation
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Citation
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Citation
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Results Reference
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Platelet Rich Plasma for Uterine Scar
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