A cross-sectional research study on Impact of covid-19 pandemic era on Pregnant Women sero-positivity for Syphilis among women attending antenatal care in India and number of babies diagnosed with Congenital Syphilis?

Sexually transmitted infections (STIs) still continue to be a major public health problem globally, affecting the quality of life as well as causing serious morbidity and mortality. STIs have a direct and signi�cant impact on reproductive and child health. They can directly cause infertility, cancers as well as pregnancy complications, and indirectly affects individual economies. The information on the number of PW found to be sero positive for Syphilis among women attending antenatal care in India and number of babies diagnosed with Congenital Syphilis is collected from HMIS electronic records of MoHFW, Government of India with key objective to know about the impact of covid-19 era i.e. 2020 and 2021 on prevalence of syphilis by comparing it with the pre pandemic era of 2018 and 2019. I collected sero positivity data for Syphilis among women attending antenatal care in India and number of babies diagnosed with Congenital Syphilis across 36 states and union territories of India including all health facilities viz. public, private, rural, urban health facilities. The data is collected, observed and analyzed with Microsoft o�ce software. The total number of pregnancies and deliveries have shown declining trend during pandemic years as compared to pre-pandemic era. Year-wise maximum number of syphilis positive pregnant women treated for syphilis were reported in 2021. The average number of babies per month diagnosed with congenital syphilis increased in pandemic era whereas average number of babies per month treated with congenital syphilis decreased in pandemic era. This research study revealed that there is an increasing number trend of following in pandemic years as compared to pre-pandemic years:


Introduction
Background/rationale Syphilis is among the one of the most common STI (sexually transmitted infections) globally, with about 6 million new cases per year.An infected pregnant woman if not diagnosed and treated early can transmit the infection to her foetus, known as "congenital syphilis".The global burden of mortality and morbidity due to congenital syphilis infection is high.The World Health Organization (WHO) reported in 2016 on global basis 661 000 total congenital syphilis cases, including: 143 000 early fetal deaths and stillbirths due to congenital syphilis [1] 61 000 neonatal deaths due to congenital syphilis [1] 41 000 preterm or low-birth weight births due to congenital syphilis [1] 109 000 infants found with a clinical diagnosis of congenital syphilis [1].
Of these adverse birth outcomes, 57% occurred in pregnant women attending antenatal care but not screened for syphilis; 16% occurred in mothers who were screened for syphilis but either did not receive treatment or received inadequate treatment.Congenital syphilis is also the second leading cause of preventable stillbirth globally, preceded only by malaria.Sexually transmitted infections (STIs) still continue to be a major public health problem globally, affecting the quality of life as well as causing serious morbidity and mortality.STIs have a direct and signi cant impact on reproductive and child health.They can directly cause infertility, cancers as well as pregnancy complications, and indirectly affects individual economies.On daily basis a million (10 lakh) STIs are acquired, in year 2012, 357 million new cases of curable STIs which includes gonorrhoea, chlamydia, syphilis and trichomoniasis occurred mainly among 15-to 49-year-olds individuals globally, out of which 5.6 million cases were of syphilis [2].Syphilis is a STI caused by bacterial infection of Treponema pallidum.It is usually transmitted during sexual contact with infectious lesions present on the mucous membranes or abraded epidermis, via blood transfusion, or vertical-transplacentally during pregnancy to the foetus.Vertical transmission of syphilis i.e. congenital syphilis is usually life-threatening to the fetus if maternal infection is not detected on time and treated early in the pregnancy.The work from home and lockdowns for covid-19 control can increase the prevalence and incidence of STI (hypothesis) as the chances for sexual relation is quite possibly increased due to availability and opportunity but this will be decided by multiple factors related to the transmission of infection.Discussing all the aspects, patho-physiology as well as clinical features etc., is not possible in this single article.Undertaking sero-sampling during the covid-19 pandemic is quite di cult when travel and household access are restricted by Covid control measures.
Pregnant mothers and newborns continue to seek health services throughout the pandemic due to their special needs.Serological tests are simple to perform at ANC visits and POC test for Syphilis can be done with the residual blood volumes of samples collected for routine ANC clinical screening for maternal infectious diseases and anaemia.Planning and provision of antenatal health care during pandemic like COVID-19 pose signi cant logistical and clinical challenges.In January 2020 rst covid-19 case was documented in India [3].Hence period from January 2020 onwards is counted as pandemic era which is still going on and period before January 2020 i.e. up to December 2019 is calculated as pre-pandemic era for this research study.

Objectives
To assess and compare the trend in sero-prevalence and number of cases of syphilis throughout the pandemic years i.e. 2020, 2021 and two previous years 2019, 2018 with key objective to nd out the trends of disease occurrence in pregnant women and newborn by analysing sero positivity for Syphilis among pregnant women attending ANC clinic at different (public-private-rural-urban) health facilities in India and number of babies diagnosed with Congenital Syphilis.

Study design
This is a cross -sectional retrospective mixed comparative research study.

Setting
Locations I collected sero positivity data for Syphilis among women attending antenatal care in India and number of babies diagnosed with Congenital Syphilis across 36 states and union territories of India including all health facilities viz.public, private, rural, urban health facilities.

Relevant dates
The period of study is from 1 st January 2018 to 31 st December 2021(forecasted with Microsoft excel software using data of pandemic year 2020 and available data of 2021).

Periods of study
The study started from 1 st January 2018 and continued up to 31 st December 2021.The author is still following the data and trends for future output of this research study.

Exposure
All the women who are registered for ANC, tested for syphilis sero-positivity and newborn diagnosed and treated with Congenital Syphilis during the research study period.

Follow-up
The data is collected continuously and checked rigorously for speci city, measurability, availability, reproducibility and timeliness.

Data collection
The information on the number of PW found to be sero positive for Syphilis among women attending antenatal care in India and number of babies diagnosed with Congenital Syphilis is collected from HMIS electronic records of MoHFW, Government of India.The data is collected, observed and analyzed with Microsoft o ce and stata software.

Participants
All pregnant women who are registered and tested for syphilis; treated for syphilis; babies diagnosed and treated for congenital syphilis during the study period as per electronic records of HMIS of MoHFW (Ministry of Health and Family Welfare), Government of India.

Eligibility criteria
Participants are eligible to be included in this research study if they are women with pregnancy registered on HMIS of MoHFW (Ministry of Health and Family Welfare), Government of India, tested for syphilis; treated for syphilis; babies diagnosed and treated for congenital syphilis during the study period as per electronic records of HMIS of MoHFW.

Sources and methods of selection of participants
The source for selection is data from HMIS and purposive sampling was done for selection of participants in order to nd answer to research question mentioned above as title of the study.

Variables
The quantitative variables included in this research study are mentioned in table-1 below (to reduce bias Total pregnancy and deliveries were also added-see table-2)

Outcomes de nition
Sero-positivity prevalence for syphilis by POC and other tests and registered on HMIS for treatment.All reported and registered congenital syphilis diagnosed and treated as per HMIS.All pregnant women registered for ANC is taken as total number of pregnancy.

Exposures
The exposures are 1.PW tested using POC or other test for Syphilis 2. PW found sero positive for Syphilis For all the variable of interest, sources of data were HMIS.

Methods of assessment (measurement)
The data is collected, observed, analysed and assessed with Microsoft o ce and stata software.

Comparability of assessment methods
The 02 pandemic years (2020 and 2021) is compared with 02 pre-pandemic years (2018 and 2019).

Data Availability
The data for study is obtained from electronic records of HMIS of MoHFW (Ministry of Health and Family Welfare), Government of India.The link for the source is given below:https://hmis.nhp.gov.in/#!/standardReports Bias The data on total number of pregnancy and delivery for study period is taken into account to reduce the bias.

Efforts to address potential sources of bias
The prevalence of sero-positivity is calculated per 100000 pregnancy registered for each year.The congenital syphilis prevalence is calculated per 100000 deliveries for each year.

Study size
The actual study size was all registered and reported pregnancies and deliveries but the key consideration is given to variables mentioned in table-1.The sizes of different variables are mentioned below in This research study revealed that there is increase in mean per month number of PW tested using POC test for Syphilis and also there increase in number of women mean per month sero for Syphilis during pandemic era using this test.The sero-prevalence/POC test decreased in all years as compared to 2018.This research study revealed that in 2019 maximum mean per month number of PW tested using other test for Syphilis whereas maximum numbers of women mean per month sero positive were found in 2021 for Syphilis using other test.The annual sero-prevalence/test of syphilis in PW tested using other test for Syphilis decreased in all years as compared to 2018 see gure-3.Year-wise maximum number of syphilis positive pregnant women treated for syphilis were reported in 2021.Figure -4 shows that average number of babies per month diagnosed with congenital syphilis increased in pandemic era whereas Figure -4 shows that average number of babies per month treated with congenital syphilis decreased in pandemic era.
The Prevalence sero-positivity for syphilis per PW was 171.2537477, 164.4711192, 185.0275772, 356.8739626 for 2018, 2019, 2020, and 2021 respectively.This novel research study revealed that there is signi cant increase in prevalence of sero-positivity for syphilis per 100000 PW during covid-19 pandemic years of 2020 and 2021(see gure-4, table-4).The author would like to point out the fact that there is also a considerable increase in tests for detecting syphilis during pandemic years.

Study Strength and Limitation
This is a cross-sectional retrospective research study based on secondary data which was one of the main limitations of this research study.Another limitation is availability of data from any other accredited and established source recognized worldwide is available.The main strength is that the whole study is based on real time based accredited government data sources and this kind of research study is unique and not available for the context of India as found by the researcher of this novel study.

Conclusion And Recommendation
During pandemic era Women and infants affected by syphilis is increasing in India.The antenatal care services utilization is also affected signi cantly in India at different rural-urban-public-private health facilities across 36 states and union territories of India [6].This may be due to covid-19 induced restrictions to stay at home (by increasing opportunity for sexual-intercourse due to lockdown etc), unsafe sexual intercourse.It is crucial to screen all pregnant women with early screening tests and treatment as early as possible with high-quality antenatal care.The health systems and government led programmes need to ensure that all PW and infants diagnosed with syphilis, are effectively treated as well as their sexual partners are tested and treated timely/properly.India and global nations can also reduce syphilis prevalence by ensuring that testing, treatment and partner reached for the infection should be implemented, beyond ANC (antenatal care).The WHO recommends screening of all pregnant

3 .
Pregnant women treated for Syphilis 4. Babies diagnosed with Congenital Syphilis and treated Predictors Sero-positivity, congenital syphilis and prevalence of syphilis Diagnostic criteria POC or other test for Syphilis Data sources/measurement

Table - 1
-variables included in this research study Number of PW tested using POC test for Syphilis Out of above, number of PW found sero positive for Syphilis Number of pregnant women tested for Syphilis by tests other then POC test Number of pregnant women tested found sero positive for Syphilis by tests other then POC test Number of syphilis positive pregnant women treated for Syphilis Number of babies diagnosed with Congenital Syphilis Number of babies treated for Congenital Syphilis

Table - 2
-Study size for each year Hence author have included the variables/indicators available at HMIS related to research question mentioned in the title of this research study and their numbers listed above in table-2 as well as numbers of PW and children's treated for the same; different groupings related to these available on HMIS were chosen as listed in table-1 and 2.Statistical methodsLinear regression is used to forecast 2021 up to December to predict future values from available past values of 2021.Prevalence per 100000 and rate per 100 is calculated for total PW and deliveries as well as for the sample size to control for confounding.Missing data for 2021 is projected by linear regression with excel.Purposive sampling strategy was undertaken by author for prevalence analysis and comparison.For increasing sensitivity the total number of pregnancy and deliveries are analysed with speci c variables of table-1.Numbers of individuals at each stage of study -The total number of pregnant women registered for ANC was considered as total number of pregnancy.The sum of all home and institutional deliveries is considered as total deliveries.The total numbers of pregnant women registered for ANC were 28715284, 29239176, 27331061, and 21891305 for years 2018-2019-2020-2021 respectively see table-2.The Total No. of Deliveries ID), were 20842188, 21571444, 20375698, 16864392 for years 2018-2019-2020-2021 respectively.total number of tested using POC test for Syphilis were 136377, 639764, 2106957, and 2580453.706for years respectively.Out of above, number of PW Why all pregnant women's were not tested for diagnosis of syphilis or they denied testing is not answerable as the data is from a secondary source but accredited source and same holds true for congenital syphilis.This research study revealed that there is an increasing number trend of following in pandemic years as compared to pre-pandemic years: Number of PW tested using POC test for Syphilis Out of above, number of PW found sero positive for Syphilis Number of babies diagnosed with Congenital Syphilis Total pregnant women tested found sero positive for Syphilis by any test Total pregnant women tested found sero positive for Syphilis by any test The total number of pregnancies and deliveries have shown declining trend during pandemic years as compared to pre-pandemic era (see gure-1, 2 and table-2).Among 215037.8089,mean per month number of PW tested using POC test for Syphilis, 2520.102785,mean per month were sero for Syphilis giving a sero-prevalence of 1.26 % in 2021(Forecasted up to December with available data of January to May 2021) see gure -4 and table-3.Of 175579.75mean month number of PW tested using POC test for Syphilis, 855.58 mean per month were sero positive for Syphilis giving a sero-prevalence of 0.49 % in to Dec).Of 53313.66mean per month number of PW tested using POC test for Syphilis, 419.33 mean per month were sero positive for Syphilis a sero-prevalence of 0.79 % in 2019 (Jan to Dec).Of 11364.75meanper month number of PW tested using POC test for Syphilis, 339.08 mean per month were sero positive for Syphilis giving a sero-prevalence of 2.98 % in 2018 (Jan to Dec) , see gure -4 and table-3.
Explanations for the study size was arrived at This is cross-sectional research study to assess the Impacts of covid-19 pandemic era on Pregnant Women sero-positivity for Syphilis among women attending antenatal care in India and number of babies diagnosed with Congenital Syphilis as well as numbers of PW and children's treated for the same.AnalysisFor each under study total numbers of variables are taken for analysis and comparison.Since this study was exclusively done for assessing impacts of covid-19 pandemic era on Pregnant Women seropositivity for Syphilis among women attending antenatal care in India and number of babies diagnosed with Congenital Syphilis

Table - 3
-Mean/month comparison of different variables in different years

Table - 4
[4]evalence comparison of different variables in different yearsThe total number of pregnant women registered for ANC was considered as total number of pregnancy.The sum of all home and institutional deliveries is considered as total deliveries.This is a cross-sectional research study to assess the Impacts of covid-19 pandemic era on Pregnant Women sero-positivity for Syphilis among women attending antenatal care in India and number of babies diagnosed with Congenital Syphilis as well as numbers of PW and children's treated for the same.Hence author have included the variables/indicators available at HMIS related to research question mentioned in the title of this research study and their numbers listed above in table-2 (b) Number of participants with missing data for each variable of interest -The missing data for each variable for 2021 were projected with Microsoft excels by linear regression.There may be under-reporting etc. which are excluded in this study.DiscussionThe average number of PW tested per month using POC test for Syphilis increased gradually from year 2018 continuously see gure 1 and table 1.There is also an increase in average number of PW found sero positive for Syphilis which indicates that increasing number of tests have detected more syphilis cases as well as less number of testing may have left several cases.It is frequently asked that which test is most diagnostic for syphilis.The Direct uorescent antibody test for T pallidum is considered as the most speci c test for the diagnosis of syphilis when lesions are present.This test utilize uorescein isothiocyanate-labelled antibody which is speci c to pathogenic Treponema[4].Very simple rapid tests for detection of syphilis are also commercially available.These are popularly known as point of care (POC) tests which can be performed without laboratory setting and with minimal training as well as no