Coronavirus disease in pregnancy. Other viral diseases complicating pregnancy, childbirth and the puerperium
Conditions
Interventions
Intervention 1: The intervention group (Probiotics+standard care treatment)will receive Lactofem synbiotic capsules (prepared by Zist-takhmir Company) twice daily after meals for at least 7 days until
Sponsors
Rasht University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: Pregnant women with mild / moderate COVID-19 hospitalization in Al-Zahra Hospital in Rasht Diagnosis based on a positive PCR or antigen test results Hospitalization on the day of admission Onset of Covid symptoms up to 5 days before admission to the study Gestational age>12 weeks Age= 16 years fever (oral temperature =37.2 ° C) Having at least one of the criteria of respiratory rate=24 per minute or oxygen saturation < 93 (without oxygen) Pa2 / Fi2 Completion of informed consent form
Exclusion criteria
Exclusion criteria: Existence of any obstetric problems such as premature rupture of the amniotic membrane, placental abruption History of receiving probiotic supplement for up to one week before enrollment Presence of underlying diseases and gastrointestinal disorders such as IBD Presence chronic diseases under treatment (such as asthma and allergies, heart failure) and acquired or congenital immunodeficiencies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration from the start of the study until the improvement of clinical symptoms. Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: Clinical examination (using patient record).;Duration from the start of the study until the improvement of paraclinical symptoms. Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: using patient record. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood Oxygen Saturation Percentage (SPO2). Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: Pulse oximeter device.;Body temperature. Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: Thermometer.;Pulse rate. Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: Clinical evaluation.;Respiratory rate. Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: Clinical evaluation.;Radiological changes. Timepoint: The day of discharge from the corona ward or earlier at the discretion of the research team. Method of measurement: Percentage of lung involvement in plain or CT scan of the chest.;Cough. Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: Clinical evaluation by a specialist physician member of the research team.;Duration of hospitalization. Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: Patients' records.;Blood pressure. Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: Patients' records.;Serious side effects. Timepoint: At any time from the start of the study until the day of discharge from the corona. Method of measurement: Clinical evaluation.;Mortality. Timepoint: At any time, based on the Patients' records. Method of measurement: Number, based on hospital records. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Seyedeh Hajar sharami
Rasht University of Medical Sciences
Outcome results
None listed