Qatar PREgnancy Covid-19 OUtcome Study (QPRECIOUS)

  • STATUS
    Recruiting
  • End date
    Apr 15, 2023
  • participants needed
    4000
  • sponsor
    Hamad Medical Corporation
Updated on 3 June 2022
Accepts healthy volunteers

Summary

The in-utero exposure of acute viral infection in some instances is proven to have short- and long-term neonatal effects during the postnatal and childhood period and the Zika virus, measles, mumps, and rubella are few examples. COVID-19 is caused by a novel coronavirus strain of unknown consequences. The main purpose of this registry is to collect baseline data and help to establish future studies and hypothesis generation.

In addition, we will be exploring the psychological impact of COVID-19 on women during the pregnancy and postnatal period. Stress and anxiety level are increased with potential adverse pregnancy and/or neonatal outcomes especially during an infectious disease outbreak. In fact, COVID-19 is associated with adverse maternal and neonatal outcomes resulting in increased levels of stress and anxiety. In addition, women during the pregnancy, peripartum, and postpartum period are at increased risk of depression. A risk that has been aggravated by social and physical isolation. Indeed, the social and physical isolation, a critically needed measure to stop the virus transmission, resulted in increased stress and depression levels and adversely affecting the mental and physical health of both the mother and the baby.

Description

The coronavirus disease 2019 or 'COVID-19' is a respiratory tract infection caused by the novel coronavirus strain initially (1). On 12th March 2020, the World Health Organization declared it as a 'pandemic' outbreak of utmost international concern. The majority of the published evidence has originated from China, where the first coronavirus patient was identified in Wuhan City in December 2019 (2,3). Previous emerging infections such as H1N1 influenza virus, Zika virus, severe acute respiratory syndrome coronavirus (SARS-CoV), and Middle East respiratory syndrome coronavirus (MERSCoV) have been shown to have a significant impact on maternal as well as perinatal outcomes (4,5).

The obstetrical population is considered vulnerable. Pregnancy involves multiple interactions with the health care system and eventually all are admitted to the hospital for delivery, therefore, managing the pregnant population presents a unique challenge during this pandemic. Additionally, the physiological changes and partial immune suppression during pregnancy make pregnant women and newborn babies susceptible to several infections. Post-partum hemorrhage, maternal sepsis, preeclampsia, premature rupture of the membrane are the most common adverse events reported to have been caused by this disease in pregnant women (11).

From the limited information gathered about the novel coronavirus, its impact on pregnancy and newborn, and the drastically increasing burden of the disease, it is vital that scientific information concerning the disease is collected and shared in a concise and practical manner. Hence, there is a need to collect case data rapidly, to pool global data on the natural history of women affected by suspected COVID-19 or confirmed SARS-CoV-2 in pregnancy to inform treatment and implement preventative strategies in this and future outbreaks. A center-based registry, gathering case data prospectively on the effect of SARS-CoV-2 infection from healthcare systems around the world offers a method to accrue clinical outcomes on key research questions from a variety of populations, and the Q- PRECIOS register will serve such purpose.

Details
Condition COVID-19, Pregnant Women
Clinical Study IdentifierNCT05349279
SponsorHamad Medical Corporation
Last Modified on3 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Pregnant woman with suspected or confirmed SARS-CoV-2 infection
Postpartum women who delivered during the last six weeks and
Neonate(s) of women included in the registry

Exclusion Criteria

Nonpregnant woman with suspected or confirmed SARS-CoV-2 infection
Postpartum women who delivered after six weeks
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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