NCT05139953

Brief Summary

To asses impact of the COVID-19 infection during Pregnancy on maternal and fetal outcome in relation to gestational age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

1.2 years

First QC Date

November 29, 2021

Last Update Submit

November 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Studying impact of COVID-19 on pregnancy

    understanding of the impact of COVID-19 on pregnancy will provide critical data about the course of the disease in pregnant women and their infants .

    baseline

Interventions

No intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All medical records of pregnant women admitted to EL Bagour Quarantine hospital, Menoufia governorate diagnosed with SARS-CoV-2 infection from May, 2020 were revised to collect maternal and neonatal data using a standardized data collection sheet. The Information included: * Age * GA * Parity * Pre-existing medical condition * Presenting symptoms at admission; such as fever, sore throat/ nasal or sinus congestion, cough/chest pain, vomiting/diarrhea, and fatigue/myalgia, dyspnea….etc. * Body mass index. * The laboratory results at admission and on discharge * Lymphopenia was defined when lymphocytes count less than 1100 cells/mm3. * Ultrasound report upon admission to the hospital that included; fetal viability, amniotic fluid index and any placental abnormality. * C.T. Report if done.

You may qualify if:

  • All medical records of the pregnant women admitted to EL Bagour Quarantine hospital, Menoufia governorate due to SARS-CoV-2 infection, as confirmed by real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay of nasopharyngeal swab specimens.

You may not qualify if:

  • Patients who had equivocal or negative testing results were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia University hospital

Shibīn al Kawm, Menoufia, 11111, Egypt

Location

Study Officials

  • Mohamed E Anter, MD

    Menoufia University-Shebin Elkom-Egypt

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of obstetrics and gynecology

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 1, 2021

Study Start

May 1, 2020

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

December 1, 2021

Record last verified: 2021-11

Locations