NCT05349279

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

May 20, 2022

Status Verified

September 1, 2021

Enrollment Period

1.9 years

First QC Date

April 26, 2022

Last Update Submit

May 16, 2022

Conditions

Keywords

Pregnant womanCOVID-19 infectionPostpartum womenNeonates

Outcome Measures

Primary Outcomes (2)

  • Retrospective Study

    Prevalence of COVID-19 and its associated sign and symptoms in pregnancy in Qatar

    April 2021 - April 2023

  • Prospective Study

    Maternal and neonatal demographic and outcomes pf pregnant women affect with COVID-19

    April 2021 - April 2023

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe COVID-19 infection during pregnancy and postnatal period.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

We will include all pregnant patients with suspected or confirmed COVID-19 infection at all HMC facilities including WWRC, CH, AKH, AWH, and its associated quarantine sites and their offspring's

You may qualify if:

  • 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

You may not qualify if:

  • Nonpregnant woman with suspected or confirmed SARS-CoV-2 infection
  • Postpartum women who delivered after six weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Wellness and Research Center

Doha, Qatar

RECRUITING

Related 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 Director-General's opening remarks at the media briefing on COVID-19-11 March 2020. Geneva, Switzerland. 2020;. (3) Guo Y, Cao Q, Hong Z, Tan Y, Chen S, Jin H, et al. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak-an update on the status. Military Medical Research. 2020; 7(1):1-10. (4) Moore CA, Staples JE, Dobyns WB, Pessoa A, Ventura CV, Da Fonseca EB, et al. Characterizing the pattern of anomalies in congenital Zika syndrome for pediatric clinicians. JAMA pediatrics. 2017; 171(3):288-295. (5) Rasmussen SA, Jamieson DJ, Honein MA, Petersen LR. Zika virus and birth defects-reviewing the evidence for causality. New England Journal of Medicine. 2016; 374(20):1981-1987. (6) The World Health Organisation. Coronavirus disease (COVID-19) Pandemic. [homepage on the Internet]. World Health Organisation; 2020 [updated April/26; cited 2020 April/26]. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019. (7) Surveillances V. The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19)-China, 2020. China CDC Weekly. 2020; 2(8):113-122. (8) Adhikari SP, Meng S, Wu Y, Mao Y, Ye R, Wang Q, et al. Epidemiology, causes, clinical manifestation and diagnosis, prevention and control of coronavirus disease (COVID-19) during the early outbreak period: a scoping review. Infectious diseases of poverty. 2020; 9(1):1-12. (9) Lai C, Shih T, Ko W, Tang H, Hsueh P. Severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) and coronavirus disease-2019 (COVID-19): the epidemic and the challenges. International journal of antimicrobial agents. 2020; :105924. (10) Mullins E, Evans D, Viner R, O'Brien P, Morris E. Coronavirus in pregnancy and delivery: a rapid review. Ultrasound in Obstetrics & Gynecology. 2020;. (11) The Royal College of Obstetricians and Gynaecologists (RCOG). Coronavirus (COVID-19) Infection in Pregnancy. London, United Kingdom: Royal College of Obstetricians and Gynaecologists; 2020. (12) Alzamora MC, Paredes T, Caceres D, Webb CM, Valdez LM, La Rosa M. Severe COVID-19 during Pregnancy and Possible Vertical Transmission. American Journal of Perinatology. 2020;. (13) Karami P, Naghavi M, Feyzi A, Aghamohammadi M, Novin MS, Mobaien A, et al. Mortality of a pregnant patient diagnosed with COVID-19: A case report with clinical, radiological, and histopathological findings. Travel Medicine and Infectious Disease. 2020; :101665. (14) Liu Y, Chen H, Tang K, Guo Y. Clinical manifestations and outcome of SARS-CoV-2 infection during pregnancy. The Journal of infection. 2020;. (15) Chen H, Guo J, Wang C, Luo F, Yu X, Zhang W, et al. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. The Lancet. 2020; 395(10226):809-815. (16) Wang1a X, Zhou2a Z, Zhang J, Zhu F, Tang Y, Shen X, et al. A case of 2019 Novel Coronavirus in a pregnant woman with preterm delivery. Clin Infect Dis. 2020; (17) Zhu H, Wang L, Fang C, Peng S, Zhang L, Chang G, et al. Clinical analysis of 10 neonates born to mothers with 2019-nCoV pneumonia. Translational pediatrics. 2020; 9(1):51.

    RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mahmoud Gasim Mohamed, M.SC

    Department of Pharmacy, Women's wellness and research center, Hamad Medical Corporatiom

    STUDY DIRECTOR
  • Salwa Abo Yaqoub, MBBS

    Hamad Medical Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Merlin Rajam, Ph.D

CONTACT

Mahmoud Gasim Mohamed, M.SC

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2022

First Posted

April 27, 2022

Study Start

May 25, 2021

Primary Completion

April 15, 2023

Study Completion

April 15, 2023

Last Updated

May 20, 2022

Record last verified: 2021-09

Locations