the Impact of Covid-19 Pandemic Stress on Pregnancy Outcomes

Covid19 Clinical Trial

Official title:

The Impact of COVID -19 Pandemic Stress on Sex Ratio at Birth and Other Pregnancy Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04839068
• Other study ID #: covid2021
• Status: Not yet recruiting
• Start date: May 1, 2021
• Est. completion date: June 2022

Study information

• Verified date: April 2021
• Source: Assiut University
• Contact: Reham Ahmed Abdel Rahim, Resident
• Phone: 01029923849
• Email: elkadyreeham[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 7000
• Est. completion date: June 2022
• Est. primary completion date: May 2022
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Covid19

Intervention

Device:
• covid 19 on pregnancy outcomes
covid 19 on pregnancy outcomes and sex ratio at birth

Locations

Country	Name	City	State
Egypt	The Clinical Obstetrics and Gynaecology department, Assuit University Hospital, Egypt	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of Covid 19 pandemic stress on sex ratio at birth		one year