Platelet Rich Plasma for Uterine Scar
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-52
SponsorThe University of Texas Health Science Center, Houston
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women undergoing elective cesarean delivery
Term pregnancy (≥37 weeks of gestation)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Platelet Rich Plasma
Other interventionInjection of 5cc of PRP preparation at the myometrium around the uterine incision after it has been sutured.
Placebo
Other interventionInjection of 5cc of 0.9% Normal Saline at the myometrium around the uterine incision after it has been sutured.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: PRP TreatmentExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Depth of the uterine scar (mm)
Depth of the uterine scar evaluated by transvaginal ultrasound
Time frame
At 6 weeks, 3 months, and 6 months after the cesarean deliverySecondary outcomes
1
Residual myometrial thickness/Adjacent myometrial thickness
Ratio between adjacent and residual myometrial thickness
Time frame
At 6 weeks, 3 months, and 6 months after the cesarean delivery2
Niche length
Niche length (mm)
Time frame
At 6 weeks, 3 months, and 6 months after the cesarean delivery3
Niche width
Niche width evaluated by transvaginal ultrasound
Time frame
At 6 weeks, 3 months, and 6 months after the cesarean deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center, Houston
Lead sponsor
Sheba Medical Center
Collaborator
Source ClinicalTrials.gov