NCT05224726

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress27%
Jul 2025Jul 2028

First Submitted

Initial submission to the registry

January 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
3.5 years until next milestone

Study Start

First participant enrolled

July 19, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

January 25, 2022

Last Update Submit

August 24, 2025

Conditions

Cesarean Section ComplicationsUterine BleedingPelvic PainMenstrual Irregularity

Keywords

uterine scar defectcesarean deliverypelvic painspottingnichecesarean section complicationuterine scarPlatelet Rich Plasma (PRP)

Outcome Measures

Primary Outcomes (1)

  • Depth of the uterine scar (mm)

    Depth of the uterine scar evaluated by transvaginal ultrasound

    At 6 weeks, 3 months, and 6 months after the cesarean delivery

Secondary Outcomes (3)

  • Residual myometrial thickness/Adjacent myometrial thickness

    At 6 weeks, 3 months, and 6 months after the cesarean delivery

  • Niche length

    At 6 weeks, 3 months, and 6 months after the cesarean delivery

  • Niche width

    At 6 weeks, 3 months, and 6 months after the cesarean delivery

Study Arms (2)

PRP Treatment

EXPERIMENTAL

PRP preparation will be injected to the myometrium around the uterine incision after closure of the first layer.

Other: Platelet Rich Plasma

Placebo

PLACEBO COMPARATOR

0.9% of Normal Saline will be injected to the myometrium around the uterine incision after closure of the first layer.

Other: Placebo

Interventions

Platelet Rich PlasmaOTHER

Injection of 5cc of PRP preparation at the myometrium around the uterine incision after it has been sutured.

PRP Treatment
PlaceboOTHER

Injection of 5cc of 0.9% Normal Saline at the myometrium around the uterine incision after it has been sutured.

Placebo

Eligibility Criteria

Age18 Years - 52 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women undergoing elective cesarean delivery
  • Term pregnancy (≥37 weeks of gestation)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Center, 55030, Israel

RECRUITING

Related Publications (11)

  • Dhurat R, Sukesh M. Principles and Methods of Preparation of Platelet-Rich Plasma: A Review and Author's Perspective. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):189-97. doi: 10.4103/0974-2077.150734.

    PMID: 25722595RESULT

  • Schilephake H. Bone growth factors in maxillofacial skeletal reconstruction. Int J Oral Maxillofac Surg. 2002 Oct;31(5):469-84. doi: 10.1054/ijom.2002.0244.

    PMID: 12418561RESULT

  • Sanchez AR, Sheridan PJ, Kupp LI. Is platelet-rich plasma the perfect enhancement factor? A current review. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):93-103.

    PMID: 12608674RESULT

  • Sharara FI, Lelea LL, Rahman S, Klebanoff JS, Moawad GN. A narrative review of platelet-rich plasma (PRP) in reproductive medicine. J Assist Reprod Genet. 2021 May;38(5):1003-1012. doi: 10.1007/s10815-021-02146-9. Epub 2021 Mar 15.

    PMID: 33723748RESULT

  • Goncalves NJN, Frantz N, de Oliveira RM. Platelet-rich plasma (PRP) therapy: An approach in reproductive medicine based on successful animal models. Anim Reprod. 2020 May 22;16(1):93-98. doi: 10.21451/1984-3143-AR2018-093.

    PMID: 33299482RESULT

  • 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.

    PMID: 34733236RESULT

  • 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.

    PMID: 34415119RESULT

  • Petryk N, Petryk M. Ovarian Rejuvenation Through Platelet-Rich Autologous Plasma (PRP)-a Chance to Have a Baby Without Donor Eggs, Improving the Life Quality of Women Suffering from Early Menopause Without Synthetic Hormonal Treatment. Reprod Sci. 2020 Nov;27(11):1975-1982. doi: 10.1007/s43032-020-00266-8. Epub 2020 Jul 22.

    PMID: 32700285RESULT

  • Wang CB, Chiu WW, Lee CY, Sun YL, Lin YH, Tseng CJ. Cesarean scar defect: correlation between Cesarean section number, defect size, clinical symptoms and uterine position. Ultrasound Obstet Gynecol. 2009 Jul;34(1):85-9. doi: 10.1002/uog.6405.

    PMID: 19565535RESULT

  • Tulandi T, Cohen A. Emerging Manifestations of Cesarean Scar Defect in Reproductive-aged Women. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):893-902. doi: 10.1016/j.jmig.2016.06.020. Epub 2016 Jul 5.

    PMID: 27393285RESULT

  • Semenova LS, Evlashko IuP, Sorkina NS. [Concentration of lead and several components of porphyrin metabolism in the blood and urine of persons with no industrial contact with lead]. Lab Delo. 1987;(2):11-4. No abstract available. Russian.

    PMID: 2437359RESULT

MeSH Terms

Conditions

Uterine HemorrhagePelvic PainMenstruation DisturbancesMetrorrhagia

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Aya A Mohr-Sasson, M.D

CONTACT

3462704682mohraya@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized control study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

January 25, 2022

First Posted

February 4, 2022

Study Start

July 19, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

August 26, 2025

Record last verified: 2025-08

Locations

IL(1)