Inflammation Markers in Fluid Aspirate From a Scarred Uterine vs. a Normal Uterine Cavity

Cesarean Section Complications Clinical Trial

Official title:

Inflammation Markers in Fluid Aspirate From a Scarred Uterine vs. a Normal Uterine Cavity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06322498
• Other study ID #: INFLAM.UTERUS-HMO-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Hadassah Medical Organization
• Contact: Chana Adler, MD
• Phone: 972-50-8779068
• Email: chanaa[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective study that will take place in the hydrosonography clinic, comparing patients with an intact uterus to those who had a caesarean section. Eligible patients will preform a transvaginal ultrasound for evaluation of presence of a niche. After fixation of the transcervical catheter, we will flush 2 ml sterile NaCl 0.9% into the uterine cavity and aspirate the fluid. After collecting all samples, the samples will be snap frozen and stored at -80o C, until they undergo an immunological analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Patients suffering from infertility and assigned for a hydrosonography exam for assessment of the integrity of the uterus and fallopian tubes.

Exclusion Criteria:

1. Patients with hydrosalpinx/pyosalpinx/sactosalpinx

2. Patients who went through surgical correction of a niche

3. Hormonal treatment- estrogens or progestins.

4. Immunosuppressive/immunomodulating medication

Related Conditions & MeSH terms

• Cesarean Section Complications
• Infertility
• Infertility Due to Nonimplantation
• Infertility Secondary
• Inflammation

Intervention

Diagnostic Test:
• Uterine lavage
Infusion of 2ml 0.9%NACL into the uterine cavity and aspiration of the fluid

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory cell population	The wash samples are processed, supernatant discarded and RBCs removed. Cells are then washed with FACS buffer ,subjected to antibody staining and examined by flow cytometry. Antibodies include: CD45,UV,CD3,CD19,CD66B,CD88, CD89, CD14,CD16,CD314,HLA-DR in order to identify monocytes, dendritic cells, T cells, B cells, NK and Neutrophil populations	Through study completion, an average of 1 year