COVID-19NCT05160649
Effect of Covid 19 Infection on Fetomaternal Outcome
An observational study of COVID-19 and COVID-19 Pneumonia, run by Fayoum University at 1 site in Egypt.
Trial summary
The novel coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was discovered for the first time in December 2019 in Wuhan (China) and the disease it causes is called coronavirus disease 2019 (COVID-19). Now, this pandemic is rapidly spreading all over the world. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- COVID-19, COVID-19 Pneumonia, Fetal Growth Retardation
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2021to Oct 2023
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: A prospective observational study
Who may be able to join
None listed.
Who cannot join
- Healthy individuals:
- Acute or chronic infectious disease,
- And any medication with known influence on immunological factors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Time of COVID 19 Infection on Fetomaternal Outcome, and Immunological Changes During the Disease Course
The novel coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was discovered for the first time in December 2019 in Wuhan (China) and the disease it causes is called coronavirus disease 2019 (COVID-19). Now, this pandemic is rapidly spreading all over the world.
Pregnant have higher rates of COVID-19, associated with hospitalizations, and severe in-hospital outcomes. Immune responses may have a potential role in the diagnosis, treatment, and prognosis of patients with COVID-19. So we need of identifying biomarkers for disease severity and progression.
Read the detailed description
It is important to define whether a novel virus is transmissible from a mother to her infant, vertical infection, and there are three possible mechanisms for vertical infection - intrauterine infection (including transplacental and ascending infections), intrapartum transmission (during delivery), and postpartum infection. These mechanisms have important implications that can influence obstetrical management decisions, best practice delivery options, and neonatal care (3).
Aim of work To detect the effect of time of infection by COVID 19 on the fetomaternal outcome including vertical transmission, and the immunological and genetic changes during the disease course.
Patients and Methods:
- All pregnant women eligible for the study will undergo detailed medical history.
- Each patient will have the following data: • Patient name. • Age. • Past medical and surgical history. • Menstrual history and contraceptive history: especially emphasis on Last Menstrual Period to determine the exact gestational age.
- Clinical examination of the patients: - General examination of vital data (blood pressure, pulse, temperature, respiratory rate). CBC, PT, PTT, RBS, ALT, AST, serum creatinine), and ultrasound will be done.
- Abdominal examination: to detect any abnormality as intrauterine growth restriction, with serial ultrasound estimation.
- Conditions
- COVID-19, COVID-19 Pneumonia, Fetal Growth Retardation
- Keywords
- COVID19 Pneumonia, Feto-maternal infection, COVID 19 placental infection, Maternal mortality, Intrauterine fetal death
- Medical subject headings
- COVID-19, Fetal Growth Retardation, Maternal Death, Stillbirth
What is being measured
The primary outcome is the main question the study is designed to answer.
First, second and third trimester fetomaternal complications.
Abdominal examination: to detect any abnormality as intra uterine growth restriction, with serial ultrasound estimation.
Measured: 3 months
fetal distress
Intrapartum fetal heart rate (FHR) to detect viability and any abnormalities. Pregnant women diagnosed to have intrapartum fetal distress (Non reassuring or pathological changes according to NICE guidelines 2017)
Measured: 3 months
Secondary outcomes (2)
fetal outcome
After birth: Apgar score will be used to identify distress newborns that need resuscitation and nicu admissionsigns of fetal pulmonary complication, acute respiratory distress syndrome.
The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. A score of 7 to 10 after five minutes is "reassuring." A score of 4 to 6 is "moderately abnormal." A score of 0 to 3 is concerning. It indicates a need for increased intervention, usually in assistance for breathing.
Measured: 3 months
Time of infection and fetal complications
Time from the diagnosis of SARS-CoV-2 infection to day of labour will be collected as a categorical factor and pre-determined to be analysed.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start10 Oct 2021
- Primary completionJun 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Fayoum 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehab abdelhamid aboshama, Fayoum University
- Investigators
- Laila E Abdelfattah, Ass. prof, Principal investigator, Associated professor of obestatrics and gynecology Faculty of medicine Fayoume universityEman E Mahmoud, lecturer, Principal investigator, Lecturer of clinical and chemical pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160649
- Sponsor's protocol ID
- S 280
- Status last verified
- Apr 2023
- First submitted
- 15 Dec 2021
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Time of COVID 19 Infection on Fetomaternal Outcome, and Immunological Changes During the Disease Course
- ClinicalTrials.gov ID
- NCT05160649
- Acronym / sponsor ID
- S 280
- Conditions
- COVID-19, COVID-19 Pneumonia, Fetal Growth Retardation
- Keywords
- COVID19 Pneumonia, Feto-maternal infection, COVID 19 placental infection, Maternal mortality, Intrauterine fetal death
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 16 Dec 2021 (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 novel coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was discovered for the first time in December 2019 in Wuhan (China) and the disease it causes is called coronavirus disease 2019 (COVID-19). Now, this pandemic is rapidly spreading all over the world.
Pregnant have higher rates of COVID-19, associated with hospitalizations, and severe in-hospital outcomes. Immune responses may have a potential role in the diagnosis, treatment, and prognosis of patients with COVID-19. So we need of identifying biomarkers for disease severity and progression.
Detailed description
It is important to define whether a novel virus is transmissible from a mother to her infant, vertical infection, and there are three possible mechanisms for vertical infection - intrauterine infection (including transplacental and ascending infections), intrapartum transmission (during delivery), and postpartum infection. These mechanisms have important implications that can influence obstetrical management decisions, best practice delivery options, and neonatal care (3).
Aim of work To detect the effect of time of infection by COVID 19 on the fetomaternal outcome including vertical transmission, and the immunological and genetic changes during the disease course.
Patients and Methods:
- All pregnant women eligible for the study will undergo detailed medical history.
- Each patient will have the following data: • Patient name. • Age. • Past medical and surgical history. • Menstrual history and contraceptive history: especially emphasis on Last Menstrual Period to determine the exact gestational age.
- Clinical examination of the patients: - General examination of vital data (blood pressure, pulse, temperature, respiratory rate). CBC, PT, PTT, RBS, ALT, AST, serum creatinine), and ultrasound will be done.
- Abdominal examination: to detect any abnormality as intrauterine growth restriction, with serial ultrasound estimation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A prospective observational study
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Healthy individuals:
- Acute or chronic infectious disease,
- And any medication with known influence on immunological factors.
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
First, second and third trimester fetomaternal complications.
Time frame: 3 months
Abdominal examination: to detect any abnormality as intra uterine growth restriction, with serial ultrasound estimation.
fetal distress
Time frame: 3 months
Intrapartum fetal heart rate (FHR) to detect viability and any abnormalities. Pregnant women diagnosed to have intrapartum fetal distress (Non reassuring or pathological changes according to NICE guidelines 2017)
2 secondary outcomes
fetal outcome
Time frame: 3 months
Time of infection and fetal complications
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Laila E Abdelfattah, Ass. prof principal investigator
Associated professor of obestatrics and gynecology Faculty of medicine Fayoume university
Eman E Mahmoud, lecturer principal investigator
Lecturer of clinical and chemical pathology
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 COVID-19 Pneumonia, run by Fayoum 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 0 inclusion and 3 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 28 Apr 2023. 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?
Results are not available in the source record.
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?
First, second and third trimester fetomaternal complications. (time frame: 3 months). 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?
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 28 Apr 2023.