Covid-19 Infection in Pregnancy

June 13, 2023 updated by: Naser Al-Husban, University of Jordan

Fetomaternal Outcomes of Pregnancies Complicated by COVID-19 Infection; Prospective Study in a Tertiary University Hospital

Prospective study of both maternal and fetal outcomes of those pregnancies that were complicated by COVID-19 infection at various gestational ages. The follow up will be from the time the diagnosis was made till discharge of the mother and her baby from the hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pregnancies that have a confirmed covid-19 infection by nasopharyngeal swab whether taken at our laboratory or confirmed at private or Ministry of health (MOH) laboratories will be followed up till delivery and discharge from the hospital.

They will be followed up for hospitalization, intensive care unit (ICU) admission, any complications (organ failure, DIC, renal failure, septic shock), intubation, mortality, miscarriage, congenital malformations, intra-uterine growth restriction (IUGR), oligohydramnios, spontaneous preterm birth, mode of delivery, birth weight, APGAR score at 1 and 5 minutes, neonatal infection with covid-19, neonatal ICU admission and breast feeding. Those patients will be followed up prospectively at our hospital and those with missed follow up and delivered outside our unit will be contacted to bring all the above-mentioned parameters. There will be no exclusion of cases.

Study Type

Observational

Enrollment (Actual)

224

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan
        • Jordan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant women who contract COVID-19 virus infection during pregnancy

Description

Inclusion Criteria:

  • pregnant women

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feto-maternal outcome
Time Frame: 1 year
fetal and maternal consequences of the infection
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Investigators

  • Study Director: Asma Basha, The University of Jordan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

January 30, 2022

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Jordan University Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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