Covid19NCT04839068
the Impact of Covid-19 Pandemic Stress on Pregnancy Outcomes
An observational study of Covid19, run by Assiut University at 1 site in Egypt.
Trial summary
This study is aiming to evaluate the effects of the COVID-19 pandemic stress on pregnancy outcomes including the sex ratio at birth. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Covid19
- What is being tested?
- covid 19 on pregnancy outcomes
- Type of treatment
- Medical device
- How many people
- 7,000 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to Jun 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
- Child, Adult, Older adult
Study population: c. Sample Size Calculation: As our study is a descriptive study aiming to explore the changes in sex ratios and other pregnancy outcomes in different months of the two years before and after COVID-19 pandemic. We will include all eligible records during those years (total coverage sample). Expected number per year according to previous records is 7000 cases
Who may be able to join
- 1. All pregnant women attended to the Women health hospital in a period from January 1st 2019 to December 31st 2019 for child birth or miscarriage (either first or second trimesters) or ectopic or molar pregnancies.
- 2. All pregnant women attended to the Women health hospital in a period from May 1st 2020 to December 31st 2021 for child birth or miscarriage (either first or second trimesters) or ectopic or molar pregnancies management.
Who cannot join
- 3. Pregnant women attended to the Women health hospital in a period from April 1st 2020 to December 31st 2021 for child birth or miscarriage (either first or second trimesters) or ectopic or molar pregnancies management who conceived before April 1st 2020
Trial locations and contacts
1 site in 1 country.
Egypt1 site
The Clinical Obstetrics and Gynaecology department, Assuit University Hospital, Egypt
Asyut
About this study
Official title: The Impact of COVID -19 Pandemic Stress on Sex Ratio at Birth and Other Pregnancy Outcomes
This study is aiming to evaluate the effects of the COVID-19 pandemic stress on pregnancy outcomes including the sex ratio at birth.
Read the detailed description
- Coronavirus disease 2019 (COVID-19) is an emerging respiratory disease caused by a single-strand, positive-sense ribonucleic acid (RNA) virus, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus (Masters, 2019).
- The sex ratio (ratio of boys to girls) at birth (SRB) is about 1.01-1.05 in most populations (Abdoli, 2020). Various influencing factors affect the SRB, including maternal stress, endocrine disruption, maternal inflammatory responses and maternal nutrition (Lipner et al., 2019).
- These stressful life events consequently influence on maternal immunological and endocrine conditions, and the male fetuses are more vulnerable to be affected by these conditions. It is of interest that male fetus is biologically weaker and more susceptible to prenatal events and diseases than female fetuses. Hence, premature death is higher in boys than girls (Ahrenfeldt et al., 2017).
- The recent pandemic of the coronavirus disease 2019 (COVID-19) has been known to have various impacts on pregnant women (Rasmussen et al., 2020). Placentas of infected mothers show inflammatory, vascular and thrombotic changes (Prochaska et al., 2020). Among the neonates, children and adults (Bjelosevic et al., 2017), higher morbidity and mortality of males than females were reported. It is observed that the incidence of stillbirth was significantly increased during the pandemic period than during the pre pandemic period in London, UK (Khalilet al., 2020).
- The start of appearance of Covid 19 cases in Egypt was in March 2020, with subsequent increase in cases with its peak in May, June and July 2020, with lockdown and social and financial affection with great stress on families
- Conditions
- Covid19
- Being tested
- covid 19 on pregnancy outcomes
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
covid 19 on pregnancy outcomesDevice
covid 19 on pregnancy outcomes and sex ratio at birth
| Study group | Role | What they receive |
|---|---|---|
| First is retrospective part | : by obtaining the data from the patients records in a period between January 1st 2019 to December 31st 2019, and from May 1st 2020 to December (excluding women conceived before April 1st 2020) Receives: Device: covid 19 on pregnancy outcomes | |
| Second is prospective part | the same data will be obtained from the patient records in the same way in a period from the January 1st 2021 to the December 31st to assess the pregnancy outcomes in pregnant women who conceived after occurrence of Covid 19 pandemic in Egypt. Receives: Device: covid 19 on pregnancy outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of Covid 19 pandemic stress on sex ratio at birth
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assiut 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
- Cross-sectional
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Ahmed Abdelreheem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839068
- Sponsor's protocol ID
- covid2021
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 9 Apr 2021
- 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 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of COVID -19 Pandemic Stress on Sex Ratio at Birth and Other Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT04839068
- Acronym / sponsor ID
- covid2021
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 9 Apr 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.
This study is aiming to evaluate the effects of the COVID-19 pandemic stress on pregnancy outcomes including the sex ratio at birth.
Detailed description
- Coronavirus disease 2019 (COVID-19) is an emerging respiratory disease caused by a single-strand, positive-sense ribonucleic acid (RNA) virus, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus (Masters, 2019).
- The sex ratio (ratio of boys to girls) at birth (SRB) is about 1.01-1.05 in most populations (Abdoli, 2020). Various influencing factors affect the SRB, including maternal stress, endocrine disruption, maternal inflammatory responses and maternal nutrition (Lipner et al., 2019).
- These stressful life events consequently influence on maternal immunological and endocrine conditions, and the male fetuses are more vulnerable to be affected by these conditions. It is of interest that male fetus is biologically weaker and more susceptible to prenatal events and diseases than female fetuses. Hence, premature death is higher in boys than girls (Ahrenfeldt et al., 2017).
- The recent pandemic of the coronavirus disease 2019 (COVID-19) has been known to have various impacts on pregnant women (Rasmussen et al., 2020). Placentas of infected mothers show inflammatory, vascular and thrombotic changes (Prochaska et al., 2020). Among the neonates, children and adults (Bjelosevic et al., 2017), higher morbidity and mortality of males than females were reported. It is observed that the incidence of stillbirth was significantly increased during the pandemic period than during the pre pandemic period in London, UK (Khalilet al., 2020).
- The start of appearance of Covid 19 cases in Egypt was in March 2020, with subsequent increase in cases with its peak in May, June and July 2020, with lockdown and social and financial affection with great stress on families
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First is retrospective part | – | Device: covid 19 on pregnancy outcomes: by obtaining the data from the patients records in a period between January 1st 2019 to December 31st 2019, and from May 1st 2020 to December (excluding women conceived before April 1st 2020) |
| Second is prospective part | – | Device: covid 19 on pregnancy outcomesthe same data will be obtained from the patient records in the same way in a period from the January 1st 2021 to the December 31st to assess the pregnancy outcomes in pregnant women who conceived after occurrence of Covid 19 pandemic in Egypt. |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- c. Sample Size Calculation: As our study is a descriptive study aiming to explore the changes in sex ratios and other pregnancy outcomes in different months of the two years before and after COVID-19 pandemic. We will include all eligible records during those years (total coverage sample). Expected number per year according to previous records is 7000 cases
Key inclusion criteria (2 listed)
- 1. All pregnant women attended to the Women health hospital in a period from January 1st 2019 to December 31st 2019 for child birth or miscarriage (either first or second trimesters) or ectopic or molar pregnancies.
- 2. All pregnant women attended to the Women health hospital in a period from May 1st 2020 to December 31st 2021 for child birth or miscarriage (either first or second trimesters) or ectopic or molar pregnancies management.
Key exclusion criteria (1 listed)
- 3. Pregnant women attended to the Women health hospital in a period from April 1st 2020 to December 31st 2021 for child birth or miscarriage (either first or second trimesters) or ectopic or molar pregnancies management who conceived before April 1st 2020
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| covid 19 on pregnancy outcomescovid 19 on pregnancy outcomes and sex ratio at birth | Device | First is retrospective part, Second is prospective part |
Primary outcome
The effect of Covid 19 pandemic stress on sex ratio at birth
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
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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.
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 Covid19, run by Assiut 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 2 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: status not confirmed, as of the sponsor's last update on 9 Apr 2021. 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?
Contact Reham Ahmed Abdel Rahim, Resident (01029923849, elkadyreeham@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of Covid 19 pandemic stress on sex ratio at birth (time frame: one year). 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 9 Apr 2021.