Effect of DrugNCT05401825
Antenatal COVID 19 Vaccination and Pregnancy Outcomes
An observational study of Effect of Drug, run by Ain Shams University at 1 site in Egypt.
Trial summary
Effect of COVID 19 vaccinations on pregnancy outcomes must be clear and identified to detect their safty Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Effect of Drug
- What is being tested?
- pfizer, astrazeneca,moderna,sinofac
- Type of treatment
- Vaccines
- How many people
- 162 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Feb 2022to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
Study population: pregnant women aged 18 years or older who received any type of COVID 19 vaccine during current pregnancy
Who may be able to join
- pregnant women aged 18 years or older who received any type of COVID 19 vaccine during current pregnancy
Who cannot join
- comorbidities,women who refused participqtion,pregnant women with previous COVID 19 infection during current pregnancy
Trial locations and contacts
1 site in 1 country.
Amr S mahmoud, lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Ainshams university
Cairo
sahar M Abdelmaksoud, masters, 01110065637, saharabdelmaksoud@yahoo.com
Amr S Mahmoud, lecturer
About this study
Official title: Antenatal COVID 19 VACCINATION and Pregnancy Outcomes
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
- Conditions
- Effect of Drug
- Being tested
- pfizer, astrazeneca,moderna,sinofac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pfizer, astrazeneca,moderna,sinofacBiological
effect of COVID 19 vaccination on pregnancy outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy loss
miscarrage or intrauterine fetal death
Measured: in first, second, third trimester
Secondary outcomes (2)
fetal malformations
detected by detailed anomaly scan
Measured: at each trimester
pregnancy related hypertensive disorders
blood pressure higher than 140/90mmHg starting from 20 weeks of gestation
Measured: starting from 20 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start18 Feb 2022
- Primary completion30 May 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed M Mamdouh, assistant professor, Study director, Ainshams universityWalid H Eltantawy, professor, Study director, Ainshams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401825
- Sponsor's protocol ID
- 2311
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal COVID 19 VACCINATION and Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT05401825
- Acronym / sponsor ID
- 2311
- Conditions
- Effect of Drug
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- pregnant women aged 18 years or older who received any type of COVID 19 vaccine during current pregnancy
Key inclusion criteria (1 listed)
- pregnant women aged 18 years or older who received any type of COVID 19 vaccine during current pregnancy
Key exclusion criteria (1 listed)
- comorbidities,women who refused participqtion,pregnant women with previous COVID 19 infection during current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pfizer, astrazeneca,moderna,sinofaceffect of COVID 19 vaccination on pregnancy outcomes | Biological | – |
Primary outcome
pregnancy loss
Time frame: in first, second, third trimester
miscarrage or intrauterine fetal death
2 secondary outcomes
fetal malformations
Time frame: at each trimester
pregnancy related hypertensive disorders
Time frame: starting from 20 weeks of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Effect of Drug
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Active, not recruitingPhase 3
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
Neuromuscular Agents, Peripheral Nervous System Agents
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr S mahmoud, lecturer contact
Ahmed M Mamdouh, assistant professor study director
Ainshams university
Walid H Eltantawy, professor study director
Ainshams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Effect of Drug, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sahar M abdelmaksoud, masters (01110065637, saharabdelmaksoud@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy loss (time frame: in first, second, third trimester). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.