Uterine Scar
Conditions
Keywords
Mesenchymal Stem Cells, Cesarean Section, Uterine Scar
Brief summary
The purpose of this study is to evaluate the safety of umbilical cord mesenchymal stem cell local intramuscular injection for treatment of uterine scars by a prospective, single-center, open, and single-arm clinical trial.
Interventions
OTHERUmbilical cord MSCs
Participants will receive direct local intramuscular injection of 1\*10\^7 MSCs (in 1ml of 0.9% saline) in the uterine incision.
Sponsors
Maternal and Child Health Hospital of Foshan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Primiparous women receiving cesarean delivery * Ages between 21-35 years * Gestation ages ≥ 37 weeks and \< 42 weeks * Willing to comply with study dosing and completed the entire course of the study * Willing to give and sign an informed consent form and a photographic release form
Exclusion criteria
* Fibroids * Placenta previa * Placenta abruption * Multiple gestation * Antepartum hemorrhage * Preeclampsia/Eclampsia * Hepatic or renal dysfunction * Any systemic uncontrolled disease * Inability to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation through vital signs, the results of clinical lab tests and adverse events | 6 months post treatment | Safety evaluation through vital signs, the results of clinical lab tests and adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of uterine scar thickness | 6 weeks, 3 and 6 months post treatment | The scar thickness be measured using a transvaginal utrasonography |
| Change of uterine scar area | 6 weeks, 3 and 6 months post treatment | The scar area will be measured using a transvaginal utrasonography |
| Number of participants with endometritis | 6 months post treatment | Endometritis is defined as the presence of at least two of the following signs with no other recognized cause: fever (temperature of at least 38℃), abdominal pain, uterine tenderness, or purulent drainage from the uterus. |
| Number of participants with uterine niche | 6 months post treatment | The niche is defined as a triangular anechoic area at the presumed site of incision in the uterus by transvaginal utrasonography. |
| Immunoglobulin concentrations in breast milk and serum | 6 weeks, 3 and 6 months post treatment | Breast milk and serum immunoglobulin (IgG, IgA, IgM) and the complement (C3, C4) are detected by transmission immune turbidity method using automatic biochemical analyzer. |
| Adverse events occurrence | 6 months post treatment | Adverse events will be evaluated since the baseline visit until 6 months after the end of the treatment. |
| Number of participants with wound infection | 6 months post treatment | Wound infection is defined as the presence of either superficial or deep incisional surgical-site infection characterized by cellulitis or erythema and induration around the incision or purulent discharge from the incision site with or without fever and included necrotizing fasciitis. |
Countries
China
Outcome results
None listed