Method
This study is a prospective cohort study conducted in Arash women’s
hospital, a university hospital affiliated with Tehran University of
Medical Sciences.
This study has been approved by the Ethics Committee of Tehran
University of Medical Sciences (IR.TUMS.VCR.REC.1398.1057).Written
consent was obtained from all participants.
In this study, all pregnant women who were hospitalized in Arash
Hospital from March 1 to April 20 2020 were evaluated in terms of
inclusion and exclusion criteria. Inclusion criteria were all pregnant
women who had been hospitalized in our hospital during the study period
and were willing to participate in the study.
Based on the presence or absence of clinical signs or symptoms of
covid-19 infection, women were divided into two general categories: One
group whose participants had clinical signs and symptoms of the virus
and the other group who did not show any clinical signs and symptoms.
Clinical symptoms have included fever, dry and progressive cough,
tachypnea , shortness of breath, decreased oxygen saturation and
fatigue. Reverse transcriptase–polymerase chain reaction for Covid-19
nucleic acid (Covid-19 PCR) test of nasopharyngeal swabs and Chest
Computed Tomography (CT) scan were performed for the group with clinical
symptoms. Women with positive Covid-19 PCR test were classified as
confirmed group. In cases with negative Covid-19 PCR test, if they had
very typical clinical symptoms verified by an infectious disease
specialist, considering the false negative probability of Covid-19 PCR
test and high diagnostic sensitivity of CT scan finding(6, 7), positive
findings of CT scan have been considered as a criterion utilized as a
tool to confirm the infection. These findings in chest CT scan included
ground-glass opacity, consolidation, reticulation/thickened interlobular
septa and nodules(6).
Women with negative results of both CT scan and Covid-19 PCR test who
had typical clinical symptoms were considered as a potentially infected
(probable group) if they had two or more of the laboratory findings
including: leukocytosis (white blood cell count
>11×109/L), lymphopenia(lymphocyte count
<1.0×109/L;),thrombocytopenia , increased
C-reactive protein (CRP)(≥10 mg/d).Women with clinical symptoms were
excluded from the study in case Covid-19 PCR test and CT scans finding
were negative and no laboratory findings were found. Women who did not
have any clinical signs or symptom of infection were considered as a
control group.
The exclusion criteria for confirmed group were positive CT scan finding
in women with mild or transient symptoms in the absence of typical
clinical symptoms. The exclusion criteria for probable group were
presence of only one paraclinical finding or the presence of only mild
and transient clinical symptoms.
In our hospital, universal screening is not performed for all inpatients
and since some of affected people may be asymptomatic(8), in order to
minimize the presence of asymptomatic individuals in the control group
as much as possible, we implemented precise exclusion criteria. So
exclusion criteria for control group included: A history of any
suspicious symptoms of the virus over the past two weeks, contact with
Covid-19 virus infected or suspected individuals within the last 14
days, any suspicious clinical symptoms of the virus over the last two
weeks in their family members, attendance in crowded areas such as
shopping malls and parties over the past 14 days, going to hospitals or
clinics for any reason within the last 14 days except for the time of
current hospitalization.
All pregnant women who were hospitalized during the study period were
screened according to the above inclusion and exclusion criteria.
Confirmed and probable infected women were treated according to the
protocols of the World Health Organization. All other managements and
procedures in three groups were performed based on obstetrics
indications and our hospital protocols. Given the lack of strong
evidence according to perform cesarean section (CS) in women infected by
the virus, our hospital’s protocol was choosing delivery method based on
other obstetrics indications. So we didn’t impose CS on women because of
corona virus infection. It’s worth mentioning that, in our hospital,
women give birth in separate rooms during childbirth, and during this
epidemic, we have decided to avoid using common tools such as birth
balls as much as possible and also doctors, residents, and midwives who
take care of each patient are specific for the same patient and do not
take care of different patients at the same time as well as use of
complete personal protective equipment.
Babies born to infected mothers underwent early cord clamping and early
temporary separation from their mothers immediately after birth and
Covid-19 PCR test was done via their nasopharyngeal and throat within
the same hour after birth.