the Impact of Covid-19 Pandemic Stress on Pregnancy Outcomes

NCT ID: NCT04839068

Last Updated: 2021-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

7000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-06-30

Brief Summary

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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

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* 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

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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)

covid 19 on pregnancy outcomes

Intervention Type DEVICE

covid 19 on pregnancy outcomes and sex ratio at birth

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.

covid 19 on pregnancy outcomes

Intervention Type DEVICE

covid 19 on pregnancy outcomes and sex ratio at birth

Interventions

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covid 19 on pregnancy outcomes

covid 19 on pregnancy outcomes and sex ratio at birth

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Reham Ahmed Abdelreheem

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Clinical Obstetrics and Gynaecology department, Assuit University Hospital, Egypt

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Reham Ahmed Abdel Rahim, Resident

Role: CONTACT

01029923849

Ahmed Nasr, prof DR

Role: CONTACT

01012588888

Other Identifiers

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covid2021

Identifier Type: -

Identifier Source: org_study_id

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