key: cord-0877304-w7pcxa4r
authors: Priyadharshini, C. Brinda; Priya, S.; Selvameena, M.; Waseemsha, S.; Muthurajesh, E.; Shalini, M.
title: “Demographic profile of COVID-19 positive mothers & their outcome in government Rajaji hospital, Madurai, Tamilnadu – A cross sectional Study”
date: 2021-09-10
journal: Clin Epidemiol Glob Health
DOI: 10.1016/j.cegh.2021.100864
sha: 4cd897219e780b99184d290d3ac5955a3d346880
doc_id: 877304
cord_uid: w7pcxa4r

BACKGROUND: COVID-19 is a new pandemic disease. This disease course and its effect on pregnancy is little known due to limited available data. The objective of this study was to describe the demographic profile of COVID-19 positive mothers admitted in Government Rajaji hospital, Madurai in terms of time, place and person and to assess the general and pregnancy outcome of study population. METHODS: This cross-sectional study was done among 381 COVID-19 positive mothers* admitted during March 22 – August 31, 2020 in dedicated COVID-19 hospital, Madurai. Data was collected using Case Investigation Form (CIF) as a part of Rapid Response Team*(RRT) by Community Medicine* Department and analysed using SPSS version 21. Descriptive statistics done; Chi-square test & Fischer exact test was done to find out association between patient profile and outcomes. RESULTS: Out of 381, 154 (40.4%) belonged to 21–25 years, 192 (50.4%) to rural area, 318 (83.5%) to 3rd trimester,189 (49.6%) Primi gravida. 125 (32.8%) were symptomatic and 153 (80.8%) had at least one comorbidity. Death as general outcome was 3 (0.8%), all of them were referred cases and had comorbidity like GDM/PIH. 10 (2.62%) had abortion or perinatal death, 14 (3.77%) had preterm delivery, 99 (25.98%) babies were born small for gestational age. Increased maternal age had more death but was not statistically significant; All symptomatic mothers (p = 0.000),1st & 2nd trimester (p = 0.000) mothers had statistically significant poor pregnancy outcome*. CONCLUSION: COVID positive mothers with increased age, symptomatic, 1st & 2nd trimester were significantly associated with poor outcome, requires special attention. Early referral must be emphasized to mitigate maternal death.

• Methods: This cross-sectional study was done among 381 COVID-19 positive mothers* admitted during March 22 -August 31, 2020 in dedicated COVID-19 hospital,Madurai. Data was collected using Case Investigation Form(CIF) as a part of Rapid Response Team*(RRT) by Community Medicine* Department and analysed using SPSS version 21.Descriptive statistics done; Chi-square test & Fischer exact test was done to find out association between patient profile and outcomes .

• Results: Out of 381, 154(40.4%) belonged to 21 -25 years, 192 (50.4%) to rural area, 318(83.5%) to 3 rd trimester,189(49.6%) Primi gravida. 125(32.8%) were symptomatic and 153(80.8%) had at least one comorbidity. Death as general outcome was 3(0.8%), all of them were referred cases and had comorbidity like GDM / PIH. 10(2.62%) had abortion or perinatal death, 14(3.77%) had preterm delivery, 99(25.98%) babies were born small for gestational age.Increased maternal age had more death but was not statistically significant; All symptomatic mothers (p=0.000) ,1 st & 2 nd trimester(p=0.000) mothers had statistically significant poor pregnancy outcome*.

Coronavirus disease is now dominating the lives of everyone globally and its history is being re-written constantly. On 31 December 2019, The World Health Organization (WHO) country Office was notified of pneumonia cases of unknown etiology from Wuhan City, Hubei province of China 1 .WHO closely monitored the situation for further outbreak. By the end of January 2020, COVID-19 spread to 20 other countries from China and hence WHO declared this disease as Public Health Emergency of International Concern (PHEIC) 2 . By the same time, India also contracted its index case of coronavirus, imported from China 3 . On March 11, 2020 more than 1,18,000 cases were detected in 114 countries and 4,291 people died due to this disease, after which WHO declared COVID-19 as pandemic 4 .

In order to curtail the spread of COVID-19, many countries announced their lockdown and other containment measures like travel restrictions, quarantine etc. India announced its 14-hour voluntary public curfew on March 22, 2020 followed by complete nationwide lockdown from March 24 -May 31,2020 5 . But once Unlock started from June 2020 there was a huge surge 6 . Due to multifactorial reasons, each Indian state experienced peak during different times 7 . Tamil Nadu was at its peak during mid-July -August 2020 8 . As on Aug 31, 2020, there were 52,379 cases in Tamil Nadu and 14,279 cases in Madurai 9 .

COVID19 affected everyone irrespective of age. However, the impact of COVID-19 on pregnant women has drawn much attention regarding maternal morbidity, mortality, and perinatal outcomes. Also, during lockdown period, pregnant mothers would have experienced difficult in access to healthcare due to movement restriction, lack of transport etc., 10 . Pregnancy, a unique immunological state faces great challenges in establishing and maintaining tolerance to the allogeneic fetus while preserving the ability for protection against microbial challenges. There is ample evidence that systemic maternal viral infections can also affect pregnancy. Previous studies have shown that SARS, MERS infection during pregnancy can lead to high rates of spontaneous abortion, premature birth, and intrauterine growth restriction etc. 11 . There is limited data and research done regarding maternal and perinatal outcome in COVID19 affected women globally, done in developed & developing countries 12, 13 . In order to gain more knowledge of COVID19 outcomes in pregnancy and for better understanding of this newly emerging disease this descriptive cross-sectional study was done. The objective of this study was to describe the demographic profile of COVID-19 positive mothers admitted in Government Rajaji hospital, Madurai in terms of time, place and person and to assess the general and pregnancy outcome of the study population. Both general outcome and pregnancy outcome were studied at the time of discharge. General outcomes included discharge and expiry of COVID-19 affected mothers. Pregnancy outcome studied were preterm, abortion, still birth and small for gestational age. Mothers with any one of these outcomes was classified under poor pregnancy outcome and the rest were classified under good pregnancy outcome. Mothers who had abortion and still birth were classified as having dead babies and rest of them were classified as having alive babies. Preterm baby was defined as baby delivered before 37 weeks of gestation. Abortion was defined as spontaneous or induced termination of pregnancy before fetal viability. Still birth was defined as baby who died after 28 weeks of pregnancy but before or during birth.Small for gestational age (SGA) was defined as birth weight of less than 10th percentile for gestational age.Gestational Diabetes Mellitus was defined as carbohydrate intolerance resulting in hyperglycemia of variable severity with onset or first recognition during pregnancy.Pregnancy Induced Hypertension was defined as systolic BP of >=140mmHg od diastolic BP of >=90 on 2 occasions at-least 15 minutes apart on same arm. Data entered in Google spread sheet was analysed using SPSS version 21.Continuous variables were expressed in mean and standard deviation and categorical variables were expressed in numbers and percentage. Chi Square test & Fischer exact test was used to find the association between the various maternal characteristics and J o u r n a l P r e -p r o o f outcome variables. Ethical clearance was obtained from Institutional Ethical Committee before the commencement of this study.

The overall mean age of our study population was 25.98 years (S.D ± 4.35). The minimum age was 18 years and the maximum age was 50 years among the COVID-19 positive mothers admitted in our hospital. Table 1 shows the demographic and obstetric details of our study population. Most of the COVID-19 positive mothers admitted belonged to age group 21-25 years (N=154,40.4%). Both rural (N=192,50.4%) and urban (N=189,49.6%) residing women were admitted in equal proportions since it was the only government COVID-19 specialty hospital nearby. Majority of the patients belonged to Madurai district (N=340,89.2%) and referral cases (N=41,10.76%) were admitted from surrounding districts. There were 189(49.6%) mothers admitted in their 1 st gravida; Most of the COVID-19 positive mothers admitted belonged to 3 rd trimester (N = 318,83.5%). Around 125(32.8%) COVID-19 positive mothers admitted in our hospital had symptoms and 153(40.2%) mothers had comorbidity. Figure 1 describes the symptom profile of our study population depicting fever (N =70,56%) as the most common symptom. Among symptomatic COVID-19 positive mothers, 101(80.8%) had single symptom while 24(19.2%) had more than 1 symptoms. Figure 2 shows the comorbidity status of the study population. Pregnancy Induced Hypertension (N=49,32%) was reported the highest followed by Hypothyroidism (N=47,30.72%), Gestational Diabetes Mellitus (N=39,25.5%) and others. About 136 (88.8%) of the study population with comorbidity had at least one comorbidity while 17 (11.2%) had more than 1 comorbidity. Table 2 shows the outcome status of our study population. General Outcome: Out of the 381 COVID-19 positive mothers admitted, 378 (99.2%) were discharged and 3 (0.8%) expired at the time of discharge. Among the discharged mothers, 28 (7.41%) were antenatal mothers and 350 (92.6%) were postnatal mothers. The 1 st death was a 50-year-old 3 rd gravida, initially asymptomatic at the time of admission later developed breathlessness, known case of Type 2 diabetes mellitus under insulin. She delivered alive preterm twins and subsequently admitted in Intensive Care Unit. She died after 3 days of admission and cause of death was COVID19 pneumonia / Acute Respiratory Distress Syndrome. The 2 nd death was a 34-year-old primi, who came with complaints of fever and cough, a known case of Pregnancy Induced Hypertension and Type 2 diabetes mellitus, delivered preterm twins by caesarean section. She developed breathlessness and went to sudden cardiorespiratory arrest within 24 hours of admission. The cause of death was COVID19 pneumonia / acute respiratory distress syndrome. The 3 rd death was a 28-year-old 2 nd gravida, came with complaints of fever and cough, known case of pregnancy induced hypertension and anemia, later developed breathlessness at the 3 rd day of admission and went to sudden cardiorespiratory arrest. The cause of death was COVID19 pneumonia / Acute Respiratory Distress Syndrome. Among the 3 death patients, 2 were symptomatic and 1 was asymptomatic. All of them had at least one comorbidity, presented to the hospital at their 3 rd trimester and delivered their babies through caesarean section. Two expired patients delivered preterm twins while alive mother delivered term baby.

Pregnancy Outcome: Out of 353 births that occurred to COVID-19 positive mothers admitted in our hospital, 343(97.2%) were alive and 10(2.8%) were dead. Among the 343 alive babies, 329 (96%) were term and 14 (4%) were preterm; 125(35.4%) were born by labor natural and 218(61.7%) by LSCS. Around 99(25.98%) babies were born small for gestational age. 10(2.8%) babies born to COVID-19 positive mothers expired. 5(50%) of them were abortions and 5(50%) of them were still birth. Out of 10 mothers with expired babies, 9(90%) were symptomatic and 3(30%) had comorbidity. It was also found that 5 (50%) of the COVID-19 positive mothers during their 1 st trimester had abortion while 4 (40%) of the 2 nd trimester mothers had either abortion or still birth and 1 (10%) mother had still birth during her 3 rd trimester. Most of the COVID-19 mothers were referred to GRH and they were mostly asymptomatic for COVID-19. They tested positive while routine screening before delivery. Most of them were not in obstetric emergency needing immediate medical attention at the time of admission. They were admitted mainly for isolation and observation. Therefore, logistic issue might have not been involved in poor pregnancy outcomes. Figure 3 shows the pregnancy outcome of study population.No neonate were tested positive for COVID-19 born to COVID-19 positive mothers. Table 3 & 4 shows the association between various factors with COVID-19 outcome and pregnancy outcome.COVID-19 death was more among increased age group,compared to younger age group but it was not statistically significant. Maternal COVID-19 symptoms were significantly associated with expiry of the baby. It showed that symptomatic mothers with fever were more prone to deliver an expired baby than mothers without fever which was statistically significant. COVID-19 positive mothers at their early trimester (I&II) had more risk of having expired baby than late trimester mothers,which was also statistically significant. Similarly, COVID19 positive mothers with comorbidity had the chance of being symptomatic and this association was also statistically significant.

Pregnant women are more prone to develop severe illness after respiratory viral infection 17 . Also, previous studies show that SARS CoV and MERS-CoV were associated with adverse clinical effects in mothers and newborn 18, 19 . Initial studies of COVID-19 during pregnancy did not address any serious maternal or neonatal complications 20 -23 . But as time goes, many studies regarding pregnancy outcome in COVID19 were researched in depth with minimal effect on the fetus 12 25 .Studies by G.Kayem et al 26 and Brandt JS et al 27 stated that advanced maternal age is a risk factor for COVID19 outcome during pregnancy. In our study also death among COVID-19 positive mothers greater than 30 years of age was higher than their counterparts but it was not statistically significant. Both rural J o u r n a l P r e -p r o o f (50.4%) and urban (49.6%) residing women were admitted in equal proportions since it was the only government COVID19 specialty hospital nearby. The reason behind this equal strength of rural and urban patients may be due to the fact that most of the antenatal mothers would have been diverted to our tertiary care hospital from their primary health centers as a part of safety measure during lockdown period. Majority of the patients belonged to Madurai district (89.2%). Most of the admitted COVID19 positive mothers were 1 st gravida (49.6%) and belonged to 3 rd trimester (83.5%). It should be noted that the higher hospitalization rate in 3 rd trimester might be due to intensive screening nearing expected date of delivery.

Anna et al 25 showed that around 69 % admitted mothers were symptomatic but in our study only 32.8 % were symptomatic at the time of admission. Around 67.2 % were asymptomatic in our study when compared to findings of Brandt JS et al 27 saying that 61.1 % were asymptomatic. This rings an alarm that asymptomatic patients may be a large burden in our society if not tested properly. The public health threat that this poses both for the transmission in the greater community and for the risk to healthcare providers-highlights the importance of universal testing for COVID-19 on labor and delivery. Also, our study says that pregnant women with at least 1 comorbidity were more prone to be symptomatic. In our study, among the 125 symptomatic patients admitted, predominantly presented with fever (N=70, 56%) & cough (N=36, 28.8%). Several other studies also had similar findings. Bachani et al 13 states that 45 (78.9%) pregnant women had low grade fever, cough and diarrhoea. Anna et al states that 17 (48%)pregnant women presented with fever at hospital admission and 16(46%) women indicated dry cough (either alone or associated with any other symptom) 25 . Huang et al reported that the early symptoms of pregnant mothers admitted with COVID19 were fever, cough, dyspnea and fatigue 28 .Study by Liu et al also stated that fever and cough were the most common symptoms in patients with COVID-19 29 .In our study, 7(5.6%) patients in postpartum had fever which was less than other studies which reported 8(23%) patients with fever in the postpartum period 25 . In our study, 40.2 % of COVID19 positive mothers had any one comorbidity similar to the findings from UK Cohort study 24 . Pregnancy Induced Hypertension (31.37%) was the commonest comorbidity found among the study population but study by Mullins et al 12 done from UK pregnancy registry showed that Gestational Diabetes Mellitus (9.7%) was most common comorbidity recorded. Study by Bachani et al 13 showed anemia, hypertension disorder and thrombocytopenia as common comorbidity.

In our study most of the admitted COVID19 mothers delivered by caesarean section (61.7%). Our general hospital statistics showed caesarean rate in COVID-19 negative mothers was lower (40.6%). A cohort study conducted at UK showed 59% of COVID19 mothers delivered by caesarean section 24 . According to NFHS-4 30 , Tamil Nadu showed a caesarean rate of 26.3%births occurred in public health facility. Most of these caesarean deliveries occurred as a precautionary step due to SARS Co-V 2 infection. But as a matter of fact, by analysing the available literature till date, the clinical outcome was generally favourable for both mothers and their new-born.

Among the 381 COVID-19 mothers, 378 (99.2 %) were discharged and 3 (0.8%) expired. Similarly Indian study by Bachani et al 13 showed 3 maternal mortalities. Systematic review regarding pregnancy and COVID outcome 31 states that studies showed that outcome of death due to COVID-19 was minimal but significant. So special attention is needed for all COVID19 positive mothers. A study conducted at UK showed preterm delivery of 12 % 24 . Another study by Brandt JS et al 27 also stated that the risk of preterm deliveries was higher among the COVID19 cases compared to the controls. But on the contrary our study findings show that 96% of babies were born at term and only 4% babies were born preterm and 99(25.98%) babies were small for gestational age. Our hospital statistics showed that 2.9% babies were preterm and 23.72 % were small for gestational age born to COVID-19 negative mothers. This study will form a base for future studies to find out risk factors associated with prematurity and small for gestational age among neonates born to COVID-19 mothers.

Our study shows that out of 353 babies born at time of discharge to COVID-19 positive mothers, 343 (97.2%) were alive and 10 (2.8%) were dead (either aborted or spontaneous expelled). But study by Bachani et al 13 showed no neonatal mortality. In our study,no neonate tested positive for COVID-19 but Bachani et al 13 showed 5 neonates tested COVID-19 positive.Particularly 1 st and 2 nd trimester COVID19 positive mothers had more risk of baby being dead and this association was statistically significant. Organogenesis occurs during the 1st & 2 nd trimester which may lead to exposure of fetus to virus causing negative pregnancy outcome. Our study also showed that if the COVID positive mothers were symptomatic, the chance of baby being dead was more than asymptomatic and this association also was statistically significant. This shows that COVID-19 may be severe in symptomatic. This finding, while preliminary, suggests that early fetal loss could be a complication in COVID19 positive mothers, and hence symptomatic mothers need more attention.

The main strength is that this study was conducted using standard questionnaire prepared by National Centre for Disease Control, in order to minimize reporting bias. Apart from the general population, special focus on pregnant women regarding effects of this newly emerging disease is the need of the hour. The limitation is that this study was conducted at a single center and no control group was allotted to compare the risk factors associated with pregnancy outcomes. Further knowledge on this disease effects on pregnancy needs more research in depth.

It would be fruitful to pursue further research on COVID-19 outcomes focusing pregnancy in order to help the policy makers in making decisions regarding screening and other necessary actions. As time progress, this newly emerging disease may become more virulent on vulnerable population, especially antenatal and postnatal women. Studies regarding vertical transmission is needed for further clarity.Hence, Early detection and intervention of COVID19 may reduce potential obstetric complications such as pregnancy loss, maternal death, preterm delivery and may be beneficial for improving maternal outcome. Since the effects of this disease is uncertain, long term follow up studies on maternal and fetal outcome must be encouraged.

J o u r n a l P r e -p r o o f FUNDING This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors.

Dataset is under the control of our institution, but it can be provided through proper channel upon requisition to corresponding author.

This work is not published previously or considered for publication. Publication is approved by all authors and by responsible authorities where work has been carried out. If accepted it will not be published elsewhere in the same form without written consent of copyright holder.

None.

Nil. J o u r n a l P r e -p r o o f 

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