COVID-19QPRECIOUSNCT05349279
Qatar PREgnancy Covid-19 OUtcome Study
An observational study of COVID-19 and Pregnant Women, run by Hamad Medical Corporation at 1 site in Qatar.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Pregnant Women
- How many people
- 4,000 participants
- Where
- 1 siteQatar
- Study dates
- 25 May 2021to 15 Apr 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- Nonpregnant woman with suspected or confirmed SARS-CoV-2 infection
- Postpartum women who delivered after six weeks
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Women's Wellness and Research Center
Doha
Merlin Abraham
About this study
Official title: Disease Registry for Pregnant Women With Suspected COVID-19 or Confirmed SARS-CoV-2 and Their Neonates.
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.
Read the 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.
- Conditions
- COVID-19, Pregnant Women
- Keywords
- Pregnant woman, COVID-19 infection, Postpartum women, Neonates
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective Study
Prevalence of COVID-19 and its associated sign and symptoms in pregnancy in Qatar
Measured: April 2021 - April 2023
Prospective Study
Maternal and neonatal demographic and outcomes pf pregnant women affect with COVID-19
Measured: April 2021 - April 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start25 May 2021
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahmoud Gasim Mohamed, M.SC, Study director, Department of Pharmacy, Women's wellness and research center, Hamad Medical CorporatiomSalwa Abo Yaqoub, MBBS, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349279
- Sponsor's protocol ID
- MRC-01-21-122
- Acronym
- QPRECIOUS
- Status last verified
- Sep 2021
- First submitted
- 26 Apr 2022
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
(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.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Registry for Pregnant Women With Suspected COVID-19 or Confirmed SARS-CoV-2 and Their Neonates.
- ClinicalTrials.gov ID
- NCT05349279
- Acronym / sponsor ID
- QPRECIOUS / MRC-01-21-122
- Conditions
- COVID-19, Pregnant Women
- Keywords
- Pregnant woman, COVID-19 infection, Postpartum women, Neonates
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 May 2021 (actual)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Apr 2023 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Nonpregnant woman with suspected or confirmed SARS-CoV-2 infection
- Postpartum women who delivered after six weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective Study
Time frame: April 2021 - April 2023
Prevalence of COVID-19 and its associated sign and symptoms in pregnancy in Qatar
Prospective Study
Time frame: April 2021 - April 2023
Maternal and neonatal demographic and outcomes pf pregnant women affect with COVID-19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Results publication(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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Gasim Mohamed, M.SC study director
Department of Pharmacy, Women's wellness and research center, Hamad Medical Corporatiom
Salwa Abo Yaqoub, MBBS principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Pregnant Women, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merlin Rajam, Ph.D (+974 70967910, MAbraham20@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective Study (time frame: April 2021 - April 2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05349279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.