Qatar PREgnancy Covid-19 OUtcome Study

COVID-19 Clinical Trial

— QPRECIOUS  

Official title:

Disease Registry for Pregnant Women With Suspected COVID-19 or Confirmed SARS-CoV-2 and Their Neonates.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05349279
• Other study ID #: MRC-01-21-122
• Status: Recruiting
• Start date: May 25, 2021
• Est. completion date: April 15, 2023

Study information

• Verified date: September 2021
• Source: Hamad Medical Corporation
• Contact: Merlin Rajam, Ph.D
• Phone: +974 70967910
• Email: MAbraham20[@]hamad.qa
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: April 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Pregnant Women

Locations

Country	Name	City	State
Qatar	Women's Wellness and Research Center	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

References & Publications (1)

(1) Sohrabi C, Alsafi Z, O'Neill N, Khan M, Kerwan A, Al-Jabir A, et al. World Health Organization declares global emergency: A review of the 2019 novel coronavirus (COVID-19). International Journal of Surgery. 2020 (2) World Health Organization. WHO Dire

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective Study	Prevalence of COVID-19 and its associated sign and symptoms in pregnancy in Qatar	April 2021 - April 2023
Primary	Prospective Study	Maternal and neonatal demographic and outcomes pf pregnant women affect with COVID-19	April 2021 - April 2023