IRCT20220408054454N1
Recruiting
Phase 3
Investigating the effect of using autologous amniotic membranes and fluid on wound healing and complications of cesarean surgery: a factorial randomized clinical trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Cesarean surgical wound.
- Sponsor
- Tehran University of Medical Sciences
- Enrollment
- 224
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18\-45 years
- •Singleton pregnancy
- •Having a previous plan for cesarean section and elective cesarean section
- •Planned gestational age of at least 36 weeks at the time of delivery
- •Able to provide informed consent
- •Intention to be available for the entire research period and to complete all relevant study steps, including follow\-up visits and phone calls
- •Hemoglobin above 10 g/dL at the time of hospitalization
Exclusion Criteria
- •Body mass index greater than or equal to 40 at the time of entering the study
- •Placenta previa or placenta accreta
- •History of intestinal or urological surgery
- •Multiple pregnancy
- •Known or suspected impairment of immunological function, including infection with HIV, hepatitis B or C
- •Use of immunosuppressive drugs, chemotherapy, radiotherapy, or taking systemic corticosteroids in the 4 weeks before surgery.
- •Known tobacco or drug use
- •Any condition that, in the opinion of the investigator, may pose a risk to the health of the participant or interfere with the evaluation of the study objectives
- •History of keloid formation
- •Participation in another clinical trial in the last three months
Outcomes
Primary Outcomes
Not specified
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