Actively Recruiting

Phase Not Applicable
Age: 18Years - 52Years
FEMALE
Healthy Volunteers
ID05224726

Platelet Rich Plasma for the Treatment of Uterine Scar to Improve Healing After Cesarean Delivery

Led by The University of Texas Health Science Center, Houston · Updated on 2025-08-26

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

T

The University of Texas Health Science Center, Houston

Lead Sponsor

S

Sheba Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of platelet-rich plasma (PRP) to improve healing of uterine scars in women undergoing elective cesarean delivery. PRP contains growth factors that support wound healing and inflammation control. The study aims to understand whether PRP can reduce complications associated with uterine scar defects, such as pelvic pain, irregular bleeding, and fertility issues, which have increased with the rising rate of cesarean deliveries. Participants will be randomly assigned to receive an injection of either PRP or a placebo (normal saline) into the myometrium around the uterine incision after the first layer of suturing during cesarean delivery. Blood will be drawn prior to surgery to prepare the PRP for those randomized to that group. The study is double-blinded, so participants will not know their assigned treatment. Follow-up visits will occur at six weeks, three months, and six months after delivery. During follow-up, participants will undergo trans-vaginal ultrasound scans to measure characteristics of the uterine scar, including depth, residual myometrial thickness, and scar dimensions. Researchers will also collect reports of symptoms like heavy bleeding, spotting, and pelvic pain. Operative and postoperative data will be recorded, including complications and recovery details. The primary outcome is the depth of the uterine scar measured at each follow-up visit.

CONDITIONS

Brief Title

Platelet Rich Plasma for Uterine Scar

Who Can Participate

Age: 18Years - 52Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women undergoing elective cesarean delivery
  • Term pregnancy (≥37 weeks of gestation)
  • Female gender
  • Age between 18 and 52 years
Not Eligible

You will not qualify if you...

  • Platelet count less than 70,000 (thrombocytopenia)
  • Connective tissue disease
  • Uterine scars from surgeries other than cesarean delivery (e.g., myomectomy, cornual resection)
  • Malformed uterus (unicornuate, bicornuate, didelphic)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of cesarean delivery

Participants undergo elective cesarean delivery. During the operation, a blood sample is drawn for platelet count and preparation of platelet rich plasma (PRP) or placebo injection around the uterine incision after closure of the first layer.

1 visit (in-person)

Post-operative Follow-up

Duration - 6 months

Participants attend gynecologic clinic visits for trans-vaginal sonographic evaluation of the uterine scar and report on uterine scar symptoms such as heavy menstrual bleeding, intermenstrual spotting, and pelvic pain.

3 visits (at 6 weeks, 3 months, and 6 months post-operation, in-person)

Trial Site Locations

Total: 1 location

1

Sheba Medical Center

Ramat Gan, Center, Israel, 55030

Actively Recruiting

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Research Team

A

Aya A Mohr-Sasson, M.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Platelet-rich plasma (PRP) therapy: An approach in reproductive medicine based on successful animal models.

Natalia Juliana Nardelli Gonçalves, Nilo Frantz, Ricardo Manuel de Oliveira

https://pubmed.ncbi.nlm.nih.gov/33299482

Evaluation of the Effects of Platelet-Rich Plasma on Follicular and Endometrial Growth: A Literature Review.

Adrielli Riboldi Ferrari, Sylvia Cortrezzi, Edson Borges...

https://pubmed.ncbi.nlm.nih.gov/34415119

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.

Nataliia Petryk, Mykhailo Petryk

https://pubmed.ncbi.nlm.nih.gov/32700285