detectable IgG/IgM antibodies at the onset of the study will be placed in the exposed group only if they have RT-PCR confirmed SARS-CoV-2 infection documented at enrolment. 2. Unexposed status will consist of pregnant women who have had negative testing for SARS-CoV-2 IgG/IgM at time of study entry and at end points: end of pregnancy and/or postpartum period. If women develop acute COVID-19 (as evidenced by positive RT-PCR testing) or demonstrate seroconversion after enrolment, they will crossover to the exposed group. Women with detectable IgG/IgM antibodies at the onset of the study will be excluded if they are RT-PCR negative. SARS-CoV-2 and pregnancy prospective cohort study Generic protocol: Last updated 2 December 2020, version 217 3. Unknown status will consist of women who have tested negative or had no testing by RT-PCR for SARS-CoV-2 at time of study entry and at end points: end of pregnancy and/or postpartum period and who have not had IgG/IgM testing. It is recommended that serology samples for this group be drawn and stored for future analysis, if/when antibody testing becomes available at a later date. 5.3 Recruitment Consecutive prospective recruitment will occur in a health-care setting where either screening and/or symptomatic testing of SARS-CoV-2 among pregnant women is ongoing; typically, this can be a clinic catering for individuals seeking care with COVID-19 suspect symptoms. Pregnancy testing may need to be offered to women of reproductive age seeking COVID-19 care, pending local circumstances. Pregnant minors are suggested to be offered inclusion in the study. If screening for SARS-CoV-2 is applied to pregnant women attending maternal and child health care or antenatal care, this can also be used to recruit consecutive SARS-CoV-2 positive and negative pregnant women. All pregnant women irrespective of SARS-CoV-2 testing or screening results will be offered to participate until sample size of exposed and unexposed groups are fulfilled. Recruitment timing in relation to pregnancy assessment and test/screening results may be implemented differentially depending on the facility and staffing resources at each study site. 1. SARS-CoV-2 positive pregnant women: Confirmed by RT-PCR testing. The areas of recruitment may differ based on local resources and SARS-CoV-2 testing protocols but should be done in a manner that limits exposure to research staff as well pregnant women. Examples of possible recruitment strategies that can be used include: by telephone consent after obtaining status of SARS-CoV-2 testing of pregnant women, at antenatal care appointments/telemedicine visits (routine screening of all pregnant women for COVID-19 can help to facilitate the identification of those who have tested positive), during hospital admission (including labour and childbirth, triage, NICU) or emergency department visit, or in collaboration with COVID-19 testing sites. 2. SARS-CoV-2 negative pregnant women: Recruitment may differ based on local resources and SARSCoV-2 testing protocols. Examples of possible recruitment strategies for this cohort can include by telephone consent after obtaining a negative SARS-CoV-2 RT-PCR test. 5.4 Sample size calculation The site-specific sample size calculations for this study are informed by estimates of composite adverse pregnancy/neonatal outcome (miscarriage, preterm birth, perinatal death or NICU admission) in women with SARS-CoV-2 infection compared to women without SARS-CoV-2 infection in pregnancy. All sample size estimates provided in this section are based on 80% statistical power and type I error at 5% level. Furthermore, this section provides examples of initial sample size estimates on the basis of the proportion expected to have the outcome of interest among the SARS-CoV-2-unexposed (p0) and also the effect size (ES). Additional information on sample size calculations can be found in Appendix B. SARS-CoV-2 and pregnancy prospective cohort study Generic protocol: Last updated 2 December 2020, version 18 The final number of pregnant women to be enrolled in each group (SARS-CoV-2 exposed versus unexposed) will need to be further inflated to account for one or more of the following factors as relevant: 1. Anticipated crossover of pregnant women from the unexposed to exposed group, assumed to be 10% (based on the current estimated prevalence of 10%); 2. Loss to follow-up (LFU) during pregnancy for the primary outcomes involving adverse pregnancy outcomes, assumed to be at 5%; 3. LFU throughout pregnancy until 6 weeks postpartum, for primary outcomes assessable from postchildbirth and by the end of 6 weeks postpartum, assumed to be at 10%; 4. For the assessment of MTCT of SARS-COV-2 via breast milk, the expected proportion of deliveries resulting in a livebirth AND neonate who is also uninfected with SARS-nCOV-2 at birth, assumed to be at XX%.4 The primary outcome is a composite outcome of any of the following: (i) miscarriage, (ii) preterm birth Toward Improving the Outcome of Pregnancy: Enhancing Perinatal Health Through Quality, Safety and Performance Initiatives (TIOP III) is a call to action. It is a tool for anyone committed to the enhancement of perinatal health: clinicians on the frontline, as well as public health professionals, researchers,