MedPath

Effect of amniotic membranes and fluid on cesarean surgery wound healing

Phase 3
Recruiting
Conditions
Cesarean surgical wound.
Infection of obstetric surgical wound
O86.0
Registration Number
IRCT20220408054454N1
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
224
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
Any serious cardiovascular, pulmonary, hepatic, renal, digestive, hematologic, endocrine, metabolic, neurological and psychological diseases
Frequent vaginal examinations
Emergency cesarean section
Chorioamnionitis or other systemic infections at the time of presentation for caesarean section, including evidence of subabdominal skin infection (e.g. fungal infection)

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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