COVID-19COVID-PREGNCT06677281
Impact of COVID-19 on Pregnancy Outcomes: a Systematic Review
An observational study of COVID-19 and Pregnancy Outcomes, run by Zahedan University of Medical Sciences at 1 site in Iran.
Trial summary
This systematic review aims to evaluate the impact of COVID-19 on pregnancy outcomes. It synthesizes data from various studies to provide insights into the effects of the virus on maternal and fetal health. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- COVID-19, Pregnancy Outcomes, Maternal Health
- What is being tested?
- Systematic Review of COVID-19's Impact on Pregnancy Outcomes
- How many people
- 1 participants
- Where
- 1 siteIran
- Study dates
- 3 May 2024to 25 Aug 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of pregnant individuals diagnosed with COVID-19 as documented in various peer-reviewed studies. The review examines the impact of COVID-19 on pregnancy outcomes, including maternal health, delivery outcomes, and neonatal complications.
Who may be able to join
- Pregnant individuals diagnosed with COVID-19.
- Studies reporting pregnancy outcomes related to COVID-19 published between January 2020 and the present.
- Articles that include quantitative data on maternal and fetal outcomes.
Who cannot join
- Studies that do not report on COVID-19-related pregnancy outcomes.
- Non-peer-reviewed articles or grey literature.
- Research focusing on non-pregnant populations.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Zahedan University of Medical Sciences
Zahedan, Sistan and Baluchestan
About this study
Official title: A Systematic Review of COVID-19's Impact on Pregnancy Outcomes
This systematic review aims to evaluate the impact of COVID-19 on pregnancy outcomes. It synthesizes data from various studies to provide insights into the effects of the virus on maternal and fetal health. The review focuses on key outcomes such as preterm birth, maternal complications, and neonatal health, utilizing comprehensive literature from peer-reviewed journals. By analyzing existing studies, we aim to identify trends and gaps in research regarding COVID-19 and pregnancy. This review is intended to inform healthcare providers and pregnant individuals about potential risks and considerations during the pandemic.
- Conditions
- COVID-19, Pregnancy Outcomes, Maternal Health, Neonatal Health
- Being tested
- Systematic Review of COVID-19's Impact on Pregnancy Outcomes
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic Review of COVID-19's Impact on Pregnancy OutcomesOther
This study is a systematic review of existing literature that examines the effects of COVID-19 on pregnancy outcomes, including maternal health, neonatal health, and obstetric complications. It synthesizes data from various studies to provide an overview of the potential risks associated with COVID-19 infection during pregnancy. This intervention does not involve any new clinical trials or direct patient interaction.
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of COVID-19 on Maternal and Neonatal Outcomes
This primary outcome measure evaluates the various maternal and neonatal outcomes associated with COVID-19 infection during pregnancy. Key metrics include rates of maternal morbidity, neonatal morbidity, preterm birth, low birth weight, and any documented complications during pregnancy, labor, and delivery. The systematic review aims to synthesize data from available studies to provide a comprehensive understanding of these outcomes and their implications for clinical practice.
Measured: The review encompasses studies published from January 2020 to the present, with a focus on maternal and neonatal outcomes reported within the specified time frame.
Secondary outcomes (1)
Effects of COVID-19 on Pregnancy-Related Complications
This secondary outcome measure assesses the frequency and types of pregnancy-related complications associated with COVID-19. This includes conditions such as gestational hypertension, gestational diabetes, placental abruption, and other adverse effects that may arise during the pregnancy period. The review aims to analyze the incidence of these complications in pregnant individuals diagnosed with COVID-19 compared to non-infected counterparts, providing insights into how the virus may impact overall pregnancy health.
Measured: The review includes data from studies published between January 2020 and the present, focusing on complications reported throughout the pregnancy and at delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start3 May 2024
- Primary completion15 Aug 2024
- Study completion25 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahedan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamidreza Kouhpayeh, Zahedan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677281
- Sponsor's protocol ID
- COVID-PREG-2024-001
- Acronym
- COVID-PREG
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systematic Review of COVID-19's Impact on Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT06677281
- Acronym / sponsor ID
- COVID-PREG / COVID-PREG-2024-001
- Conditions
- COVID-19, Pregnancy Outcomes, Maternal Health, Neonatal Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Zahedan University of Medical SciencesUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 6 Nov 2024 (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.
This systematic review aims to evaluate the impact of COVID-19 on pregnancy outcomes. It synthesizes data from various studies to provide insights into the effects of the virus on maternal and fetal health. The review focuses on key outcomes such as preterm birth, maternal complications, and neonatal health, utilizing comprehensive literature from peer-reviewed journals. By analyzing existing studies, we aim to identify trends and gaps in research regarding COVID-19 and pregnancy. This review is intended to inform healthcare providers and pregnant individuals about potential risks and considerations during the pandemic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of pregnant individuals diagnosed with COVID-19 as documented in various peer-reviewed studies. The review examines the impact of COVID-19 on pregnancy outcomes, including maternal health, delivery outcomes, and neonatal complications.
Key inclusion criteria (3 listed)
- Pregnant individuals diagnosed with COVID-19.
- Studies reporting pregnancy outcomes related to COVID-19 published between January 2020 and the present.
- Articles that include quantitative data on maternal and fetal outcomes.
Key exclusion criteria (3 listed)
- Studies that do not report on COVID-19-related pregnancy outcomes.
- Non-peer-reviewed articles or grey literature.
- Research focusing on non-pregnant populations.
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 |
|---|---|---|
| Systematic Review of COVID-19's Impact on Pregnancy OutcomesThis study is a systematic review of existing literature that examines the effects of COVID-19 on pregnancy outcomes, including maternal health, neonatal health, and obstetric complications. It synthesizes data from various studies to provide an overview of the potential risks associated with COVID-19 infection during pregnancy. This intervention does not involve any new clinical trials or direct patient interaction. | Other | – |
Primary outcome
Impact of COVID-19 on Maternal and Neonatal Outcomes
Time frame: The review encompasses studies published from January 2020 to the present, with a focus on maternal and neonatal outcomes reported within the specified time frame.
This primary outcome measure evaluates the various maternal and neonatal outcomes associated with COVID-19 infection during pregnancy. Key metrics include rates of maternal morbidity, neonatal morbidity, preterm birth, low birth weight, and any documented complications during pregnancy, labor, and delivery. The systematic review aims to synthesize data from available studies to provide a comprehensive understanding of these outcomes and their implications for clinical practice.
1 secondary outcome
Effects of COVID-19 on Pregnancy-Related Complications
Time frame: The review includes data from studies published between January 2020 and the present, focusing on complications reported throughout the pregnancy and at delivery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19 and Pregnancy Outcomes, run by Zahedan University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 6 Nov 2024. 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 Iran. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of COVID-19 on Maternal and Neonatal Outcomes (time frame: The review encompasses studies published from January 2020 to the present, with a focus on maternal and neonatal outcomes reported within the specified time frame.). 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 6 Nov 2024.