COVID-19 PandemicNCT05608616
Maternal and Fetal Outcomes in Pregnant Women With COVID -19,a Cross Sectional Study
An observational study of COVID-19 Pandemic, run by Cairo University at 1 site in Egypt.
Trial summary
The spread of a new coronavirus (SARS-CoV-2) from Wuhan, China, has been fast, and the World Health Organization (WHO) declared a pandemic on March 11th, 2020 .It has now spread worldwide and is one of the most severe public health threats.The clinical characteristics of COVID-19 and the likelihood of transmission… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- COVID-19 Pandemic
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 Oct 2022
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: A retrospective analysis of prospectively collected data of pregnant women confirmed as COVID-19 infected. Maternal and fetal morbidities and adverse obstetrical outcomes among those with COVID-19 will be analyzed. Maternal outcomes will include:Venous thromboembolic events,pregnancy outcome,mode of delivery,frequency of admission to ICU,need for assistive ventilation,mortality rate Fetal outcomes will include:Frequency of NICU admission,Preterm birth,Intrauterine growth restriction,Intrauterine fetal death,Congenital fetal malformations.
Who may be able to join
- Pregnant women of any gestational age with confirmed COVID 19 diagnosis attended and admitted at inpatient ward for management and follow up from April 2020 to December 2021at Kasr El Ainy hospital,Cairo university
Who cannot join
- there is no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 and Pregnancy Maternal and Fetal Outcomes,A Retrospective Cross Sectional Study
The spread of a new coronavirus (SARS-CoV-2) from Wuhan, China, has been fast, and the World Health Organization (WHO) declared a pandemic on March 11th, 2020 .It has now spread worldwide and is one of the most severe public health threats.The clinical characteristics of COVID-19 and the likelihood of transmission vertically or during delivery in pregnant women are still unknown.
Read the detailed description
In this cross sectional study,the following questions require immediate attention: whether COVID-19 symptoms in pregnant women differ from symptoms in non-pregnant women; whether disease complications and mortality rates are higher in pregnant women than in non-pregnant women; and whether there is a risk of premature delivery, foetal mortality, or even vertical transmission of the disease. These questions must be answered in order to plan optimal obstetrical management for pregnant women with COVID-19
- Conditions
- COVID-19 Pandemic
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcomes of Pregnancy with COVID-19
Prevalence of maternal and fetal morbidities and adverse obstetrical outcomes among pregnant women with COVID-19 diagnosis.
Measured: 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Apr 2022
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mostafa Mohammed Refaay El shemy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608616
- Sponsor's protocol ID
- COVID-19 and pregnancy
- Status last verified
- Nov 2022
- First submitted
- 5 Nov 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 and Pregnancy Maternal and Fetal Outcomes,A Retrospective Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05608616
- Acronym / sponsor ID
- COVID-19 and pregnancy
- Conditions
- COVID-19 Pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 8 Nov 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 spread of a new coronavirus (SARS-CoV-2) from Wuhan, China, has been fast, and the World Health Organization (WHO) declared a pandemic on March 11th, 2020 .It has now spread worldwide and is one of the most severe public health threats.The clinical characteristics of COVID-19 and the likelihood of transmission vertically or during delivery in pregnant women are still unknown.
Detailed description
In this cross sectional study,the following questions require immediate attention: whether COVID-19 symptoms in pregnant women differ from symptoms in non-pregnant women; whether disease complications and mortality rates are higher in pregnant women than in non-pregnant women; and whether there is a risk of premature delivery, foetal mortality, or even vertical transmission of the disease. These questions must be answered in order to plan optimal obstetrical management for pregnant women with COVID-19
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A retrospective analysis of prospectively collected data of pregnant women confirmed as COVID-19 infected. Maternal and fetal morbidities and adverse obstetrical outcomes among those with COVID-19 will be analyzed. Maternal outcomes will include:Venous thromboembolic events,pregnancy outcome,mode of delivery,frequency of admission to ICU,need for assistive ventilation,mortality rate Fetal outcomes will include:Frequency of NICU admission,Preterm birth,Intrauterine growth restriction,Intrauterine fetal death,Congenital fetal malformations.
Key inclusion criteria (1 listed)
- Pregnant women of any gestational age with confirmed COVID 19 diagnosis attended and admitted at inpatient ward for management and follow up from April 2020 to December 2021at Kasr El Ainy hospital,Cairo university
Key exclusion criteria (1 listed)
- there is no exclusion criteria
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
Outcomes of Pregnancy with COVID-19
Time frame: 32 months
Prevalence of maternal and fetal morbidities and adverse obstetrical outcomes among pregnant women with COVID-19 diagnosis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pandemic, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Nov 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcomes of Pregnancy with COVID-19 (time frame: 32 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2022.