Risk factors of COVID-19 vertical transmission among pregnant and non-pregnant Filipinos in Metro Manila: a multicentre cohort study protocol

Abstract

IntroductionThe novel (COVID-19 was first reported to have originated in Wuhan, China, in December 2019. This new strain, SARS‐CoV‐2, has spread rapidly worldwide, prompting the WHO to declare the COVID-19 outbreak a global pandemic. The main objective of this cohort study is to determine the risk factors of COVID-19, the modes of COVID-19 vertical transmission, and the maternal and fetal outcomes among non-pregnant and pregnant women and their fetuses.Methods and analysisThis is a multicentre epidemiological study that will involve a prospective cohort. COVID-19 status among consulting non-pregnant and pregnant women in public hospitals in Manila, Philippines, will be determined and monitored for 6–12 months. Swab specimens from the nasopharynx, cervix, rectum, amniotic fluid, placenta, cord blood and breastmilk will be collected during consult and admission for reverse transcription-PCR (RT-PCR) testing. Blood will be collected during the postdelivery period to monitor the women and their neonates for any undue development and determine the antibody development to indicate an infective or non-infective state. Evidence of vertical transmission will be explored with the presence or absence of the virus using the maternal and fetal neonatal RT-PCR and lateral flow antibody status. Descriptive and inferential statistics will be done, including the associations between exposures and risk factors, description of clinical characteristics, and the COVID-19 status of the participants.Ethics and disseminationThe Single Joint Research Ethics Board of the Department of Health has approved this protocol (SJREB 2020-30). The study results will be disseminated through conference presentations, peer-reviewed articles, and various stakeholder public forums and activities.

Factors associated with having COVID-19 among unvaccinated pregnant and non-pregnant women in Metro Manila, Philippines: a multicentre longitudinal cohort study

“…This study is part of a comprehensive prospective multicentre cohort study protocol to determine the risk factors, clinical manifestations, progression and maternal-neonatal outcomes of COVID-19 vertical transmission among pregnant and non-pregnant women in Metro Manila. 11 Specific details on the procedures can be found in the said protocol.…”

“…Quantitative variables (ie, age, income) were categorised following the protocol for this study. 11 Descriptive statistics profiled the sociodemographic, lifestyle and Ob-Gyn characteristics of pregnant and non-pregnant cohorts. The crude prevalence ratio (cPR) and the corresponding 95% CI were calculated after regressing a bivariable generalised linear model using a Poisson distribution with robust variance correction and a log link function between the characteristics as predictors, and COVID-19 status as the outcome.…”

“…Laboratory determination of SARS-CoV-2 and pregnancy status were carried out after collection of samples from the participants. They were also given a validated self-administered structured COVID-19 infection in adults questionnaire adapted from the New South Wales Department of Health 11. The questionnaire will profile the sociodemographic, lifestyle, Ob-Gyn, medical history and pregnancy-related characteristics of each participant.…”

“…The data are expressed as the summation of all respondents that exhibited either infected or uninfected outcomes throughout the entire study duration as the prevalence period. Quantitative variables (ie, age, income) were categorised following the protocol for this study 11. Descriptive statistics profiled the sociodemographic, lifestyle and Ob-Gyn characteristics of pregnant and non-pregnant cohorts.…”

Method Validation Study for SARS-CoV-2 Viral RNA Detection in Cervical, Rectal, Amniotic Fluid, Placental, Umbilical Cord Blood, and Breastmilk Specimens in a Cohort of Unvaccinated Women in Manila, Philippines

“…This study aimed to validate a method for SARS-CoV-2 detection among swabs collected from the cervix, rectum, amniotic fluid, placenta, umbilical cord blood, and breast milk using a validated PCR method for respiratory specimens as part of the longitudinal study on risk factors, clinical characteristics, and transmission of COVID-19 in both non-pregnant and pregnant women in the Philippines. 14…”