Antenatal COVID 19 Vaccination and Pregnancy Outcomes | NCT05401825

Studies
Antenatal COVID 19 Vaccination and Pregnancy Outcomes

NCT05401825

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Jun 2, 2022Actual

Enrollment

162Estimated

Phase

Not provided

Conditions

Effect of Drug

Interventions

pfizer, astrazeneca,moderna,sinofac

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 18, 2022Actual

Primary Completion Date

May 30, 2024Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

Jun 1, 2022

First Submission Date that Met QC Criteria

Jun 1, 2022

First Posted Date

Jun 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2022

Last Update Posted Date

Jun 2, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

162Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pfizer, astrazeneca,moderna,sinofac	Biological	effect of COVID 19 vaccination on pregnancy outcomes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pregnancy loss	miscarrage or intrauterine fetal death	in first, second, third trimester

Secondary Outcomes

Measure	Description	Time Frame
fetal malformations	detected by detailed anomaly scan	at each trimester
pregnancy related hypertensive disorders	blood pressure higher than 140/90mmHg starting from 20 weeks of gestation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant ladies received COVID 19 vaccine during pregnancy

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
sahar M abdelmaksoud, masters	Contact	01110065637		saharabdelmaksoud@yahoo.com
Amr S mahmoud, lecturer	Contact	+201010051381

Overall Officials

Name	Affiliation	Role
Ahmed M Mamdouh, assistant professor	Ainshams university	Study Director
Walid H Eltantawy, professor	Ainshams university	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ainshams university	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided