CClinicalTrials.gg
Status unknownNCT05401825Updated Jun 2, 2022

Antenatal COVID 19 Vaccination and Pregnancy Outcomes

An observational study in Effect of Drug, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-06-02.

Sponsored by Ain Shams University · Observational

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
162
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

Effect of COVID 19 vaccinations on pregnancy outcomes must be clear and identified to detect their safty

Read the detailed description

in this study we will discuss side effects of COVID 19 vaccine on pregnant women including the incidence of miscarrage , intrauterine fetal deaths, liquor abnormalities, preeclampsia, accidental hemorrhage , we also will follow up pregnant women who received any type of COVID 19 vaccine till delivery and discuss the effect of the vaccine on fetus and newborn

02

Conditions studied

  • Effect of Drug
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

pregnant women aged 18 years or older who received any type of COVID 19 vaccine during current pregnancy

Inclusion criteria

  • pregnant women aged 18 years or older who received any type of COVID 19 vaccine during current pregnancy

Exclusion criteria

Exclusion Criteria:

  • comorbidities,women who refused participqtion,pregnant women with previous COVID 19 infection during current pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
162 participants (estimated)
Patient registry
No

Interventions

  • Biologicalpfizer, astrazeneca,moderna,sinofac

    effect of COVID 19 vaccination on pregnancy outcomes

06

What researchers measure

Primary outcomes

  1. pregnancy loss

    miscarrage or intrauterine fetal death

    Time frame: in first, second, third trimester

Secondary outcomes

  1. fetal malformations

    detected by detailed anomaly scan

    Time frame: at each trimester

  2. pregnancy related hypertensive disorders

    blood pressure higher than 140/90mmHg starting from 20 weeks of gestation

    Time frame: starting from 20 weeks of gestation

07

Study locations

1 of 1 sites recruiting
  • Ainshams university
    Cairo, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05401825
Lead sponsor
Ain Shams University
Responsible party
Sponsor
First posted
Jun 2, 2022
Start date
Feb 18, 2022
Primary completion
May 30, 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Jun 2, 2022

Study contacts

sahar M abdelmaksoud, masters
Contact
saharabdelmaksoud@yahoo.com
01110065637
Amr S mahmoud, lecturer
Contact
+201010051381
Ahmed M Mamdouh, assistant professor
study director · Ainshams university
Walid H Eltantawy, professor
study director · Ainshams university

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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