Pregnancy and neonatal outcomes of COVID-19 – co-reporting of common outcomes from the PAN-COVID and AAP SONPM registry

  1. Edward Mullins
  2. Mark L. Hudak
  3. Jayanta Banerjee
  4. Trace Getzlaff
  5. Julia Townson
  6. Kimberly Barnette
  7. Rebecca Playle
  8. Tom Bourne
  9. Christoph Lees

Reviewed by

Read the full article

Listed in

Log in to save this article

Abstract

Background

Few large, cohort studies report data on individual’s maternal, fetal, perinatal, and neonatal outcomes associated with SARS-CoV-2 infection in pregnancy. We report outcomes from a collaboration formed early during the pandemic between the investigators of two registries, the UK and global Pregnancy and Neonatal outcomes in COVID-19 (PAN-COVID) study and the US American Academy of Pediatrics Section on Neonatal Perinatal Medicine (AAP SONPM) National Perinatal COVID-19 Registry.

Methods

PAN-COVID (suspected or confirmed SARS-CoV-2 infection at any stage in pregnancy) and the AAP SONPM registry (positive maternal testing for SARS-CoV-2 from 14 days before delivery to 3 days after delivery) studies collected data on maternal, fetal, perinatal and neonatal outcomes. PAN-COVID results are presented as all inclusions and those with confirmed SARS-CoV-2 infection only.

Results

We report 4004 women in pregnancy affected by suspected or confirmed SARS-CoV-2 infection (1606 from PAN-COVID and 2398 from the AAP SONPM) from January 1 st 2020 to July 25 th 2020 (PAN-COVID) and August 8 th (AAP SONPM). For obstetric outcomes in PAN-COVID and AAP SONPM, respectively, maternal death occurred in 0.5% and 0.17%, early neonatal death in 0.2% and 0.3%, and stillbirth in 0.50% and 0.65% of women. Delivery was pre-term (<37 weeks gestation) in 12% of all women in PAN-COVID, in 16.2% of those women with confirmed infection in PAN-COVID and 16.2% of women in AAP SONPM. Very preterm delivery (< 27 weeks’ gestation) occurred in 0.6% in PAN-COVID and 0.7% in AAP SONPM.

Neonatal SARS-CoV-2 infection was reported in 0.8% of PAN-COVID all inclusions, 2.0% in PAN-COVID confirmed infections and 1.8% in the AAP SONPM study; the proportions of babies tested were 9.5%, 20.7% and 87.2% respectively.

The proportion of SGA babies was 8.2% in PAN-COVID all inclusions, 9.7% in PAN-COVID confirmed infection and 9.6% in AAP SONPM. Gestational age adjusted mean z-scores were −0.03 for PAN-COVID and −0.18 for AAP SONPM.

Conclusions

The findings from the UK and US SARS-CoV-2 in pregnancy registries were remarkably concordant. Pre-term delivery affected a higher proportion of women in pregnancy than expected from historical and contemporaneous national data. The proportions of women affected by stillbirth, small for gestational age infants and early neonatal death were comparable to historical and contemporaneous UK and US data. Although maternal death was uncommon, the proportion was higher than expected from UK and US population data, likely explained by under-ascertainment of women affected by milder and asymptomatic infection in pregnancy. The data presented support strong guidance for enhanced precautions to prevent SARS-COV-2 infection in pregnancy, particularly in the context of increased risks of preterm delivery and maternal mortality, and for priority vaccination of women planning pregnancy.

What is known about SARS-COV-2 infection in pregnancy and neonates?

Cohort, population surveillance studies and living systematic reviews have included limited numbers of women in pregnancy affected by COVID-19 and report that most women and infants had good outcomes.

What this study adds

Preterm deliveries occurred in a high proportion of women participating in these two registries in comparison to contemporaneous and historical national data in the UK and US. The majority of preterm deliveries occurred late preterm (between 32+0 and 36+6 weeks’ gestation).

SARS-COV-2 infection in pregnancy did not appear to be associated with a clinically significant effect on the rate of stillbirth, fetal growth, or neonatal outcomes.

Although maternal death was uncommon, the proportion was higher than expected from UK and US population data, likely explained by under-ascertainment of women affected by milder and asymptomatic infection in pregnancy.

Article activity feed

  1. ScreenIT

    SciScore for 10.1101/2021.01.06.21249325: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementConsent: Recruitment was by verbal consent and retrospective inclusion was permitted.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variableThe PAN-COVID study used a purpose-built Elsevier Macro database and collected outcome data from pregnant women with confirmed or suspected SARS-CoV-2 infection who delivered between 1/1/2020 and 31/3/2021 and their neonates.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    The AAP SONPM National Perinatal COVID-10 Registry collect data via a REDCap database from pregnant women who tested positive for SARS-COV-2 on specimens obtained between 14 days before delivery to 3 days after delivery and opened on 4/1/2020.
    REDCap
    suggested: (REDCap, RRID:SCR_003445)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Strengths and weaknesses: This combined PAN-COVID and AAP SONPM report comprises the largest individual patient dataset of maternal and neonatal outcomes among women with suspected or confirmed SARS-CoV-2 infection. Standardised, online data-reporting with follow-up for missing data ensured a high proportion of complete data. Although there are some differences in populations (e.g., mean maternal age and race/ethnicity distributions), demographic and outcome data from these two registries are otherwise comparable and support the generalisability of the findings. Both studies report more frequent preterm delivery than expected from contemporaneous and historical UK and US national data; the proportions for both outcomes are comparable between the studies despite the different healthcare settings. In PAN-COVID, the higher than expected proportion of women included who died can be explained in part by under-ascertainment of pregnant women with SARS-CoV-2 who had mild or asymptomatic infection. Data were collected from a range of healthcare settings, but the majority of participants originated from the US and UK with 11.1% of inclusions from PAN-COVID centres in Italy, China, Greece, Indonesia and India. This was a centre-based registry, centres with little exposure to COVID-19 or those which were overwhelmed during the pandemic may have been less motivated or able to participate. This study does not allow conclusions to be drawn on the underlying factors relating to either the d...

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    ISRCTN68026880NANA

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a protocol registration statement.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. Version published to 10.1101/2021.01.06.21249325v1 on medRxiv