QPRECIOUS: Qatar PREgnancy Covid-19 OUtcome Study

Sponsor

Hamad Medical Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05349279

Collaborator

(none)

4,000

Enrollment

Location

22.7

Anticipated Duration (Months)

176.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pregnant Women

Detailed 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

4000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

May 25, 2021

Anticipated Primary Completion Date :

Apr 15, 2023

Anticipated Study Completion Date :

Apr 15, 2023

Outcome Measures

Primary Outcome Measures

Retrospective Study [April 2021 - April 2023]
Prevalence of COVID-19 and its associated sign and symptoms in pregnancy in Qatar
Prospective Study [April 2021 - April 2023]
Maternal and neonatal demographic and outcomes pf pregnant women affect with COVID-19

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women's Wellness and Research Center	Doha		Qatar

Sponsors and Collaborators

Hamad Medical Corporation

Investigators

Study Director: Mahmoud Gasim Mohamed, M.SC, Department of Pharmacy, Women's wellness and research center, Hamad Medical Corporatiom
Principal Investigator: Salwa Abo Yaqoub, MBBS, Hamad Medical Corporation