Maternal and neonatal outcomes from women infected with SARS-COV2 (COVID-19) during pregnancy

Prospective registry of maternal, perinatal and neonatal outcomes from pregnancies infected with SARS-COV2 (COVID-19)

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12620000449932

Enrollment

200

Registered

2020-04-06

Start date

2020-04-10

Completion date

2021-04-01

Last updated

2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a national study of women with confirmed COVID-19 in pregnancy in Australia. The study will collect information about all pregnant women who are confirmed to have SARS- CoV2 infection. The information will be analysed on a continuous basis to inform ongoing guidance for women and maternity staff as we respond to the pandemic. Specifically, the study will describe incidence, management and outcomes of COVID-19 in pregnancy and identify factors associated with better outcomes for women and their babies. Anonymous information will be collected by clinicians or clinical researchers who are based in maternity units in the Australia. Data collectors will have been sent a live link to a RedCap database to allow them to notify cases and complete an anonymous data collection form. SARs-COV-2 is a new strain of coronavirus that has not previously been identified in humans. which causes a respiratory illness, but it is not known what impact it will have on pregnant women and their babies. In order to investigate risk factors, management and outcomes, the researchers plan to extend data collection to include data on all pregnant women with SARS-CoV-2. The aim of this study is to learn more about the effects of SARS-COV-2 and its treatment on pregnant women and their babies. Pregnant women, are known to be at increased risk of developing more serious problems from respiratory viral infections, as was shown in the MERs, SARS and H1N1 'swine flu' epidemics. But little is currently known about this virus. This study will collect and report contemporary data to inform ongoing pregnancy and neonatal management in order to optimise modifiable outcomes.

Interventions

All women infected with SARS-CoV 2 (novel coronavirus) infection or who were diagnosed with COVID-19 during pregnancy. Observation will continue throughout pregnancy up until 6 weeks postpartum. In addition to standard care, women will be asked to complete a questionnaire after discharge to include postpartum and neonatal outcomes.

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

All pregnant women admitted to a participating hospital with COVID-19 during pregnancy

Exclusion criteria

Suspected COVID-19 not subsequently confirmed on PCR, serology or imaging

Outcome results