NCT04839068

Brief Summary

This study is aiming to evaluate the effects of the COVID-19 pandemic stress on pregnancy outcomes including the sex ratio at birth.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

April 9, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

April 8, 2021

Last Update Submit

April 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • The effect of Covid 19 pandemic stress on sex ratio at birth

    one year

Study Arms (2)

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)

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.

Device: covid 19 on pregnancy outcomes

Interventions

covid 19 on pregnancy outcomes and sex ratio at birth

First is retrospective partSecond is prospective part

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • \- 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.
  • \. 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.

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Asyut, Egypt

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Reham Ahmed Abdel Rahim, Resident

CONTACT

Ahmed Nasr, prof DR

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 9, 2021

Study Start

May 1, 2021

Primary Completion

May 1, 2022

Study Completion

June 1, 2022

Last Updated

April 9, 2021

Record last verified: 2021-04

Locations