COVID-19NCT06557694
Effect of COVID-19 Infection on Obstertric Complications and Maternal Outcomes
An observational study of COVID-19 and Infection, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the effect of COVID-19 infection on obstetric complications and maternal outcomes. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- COVID-19, Infection, Obstetric Complication
- What is being tested?
- Data collection
- How many people
- 260 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Dec 2022
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: This retrospective study was carried out on 260 pregnant women with COVID-19 infection who presented in Tanta University Hospitals in the period from January 2021 to December 2022 with approval from the institutional ethical committee.
Who may be able to join
- Age from 18 to 40 years.
- Pregnant women with COVID-19 infection diagnosed either by PCR or rapid test.
Who cannot join
- Patients vaccinated for COVID-19 before or during the current pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate the effect of COVID-19 infection on obstetric complications and maternal outcomes.
Read the detailed description
During the SARS-CoV-2 pandemic, pregnant women were reported to have a higher susceptibility to COVID-19 infection. Pregnant women who tested positive for SARS-CoV-2 are at higher risk of a severe form of COVID-19, associated with higher rates of intensive care unit (ICU) admission and increased needs for respiratory support, compared to the age-matched non-pregnant population.
Women infected during pregnancy also have an increased risk of adverse pregnancy outcomes including preterm-birth, with a significant proportion secondary to iatrogenic preterm birth due to maternal illness. Infection with SARS-CoV-2 during pregnancy has also been reported to be associated with a higher risk of stillbirth directly or indirectly caused by the virus.
Infected pregnant patients tended to present asymptomatically with pre-Delta and Omicron variants, and symptomatically with Delta variant. A previous systematic review suggested that people who are pregnant did not have an increased risk of SARS-CoV-2 infection or symptomatic COVID-19, but they were at risk of severe COVID-19 compared with those who were not pregnant.
- Conditions
- COVID-19, Infection, Obstetric Complication, Maternal Outcomes
- Being tested
- Data collection
- Medical subject headings
- COVID-19, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collected included maternal demographics, medication during pregnancy, the gestational week when COVID-19 was diagnosed, antenatal diseases occurring after COVID-19 detection during pregnancy, intrauterine growth retardation (IUGR), small for gestational age (SGA), fetal distress, intrauterine fetal demise (IUFD), intrapartum complications, gestational age (GA) at delivery, mode of delivery, postpartum hemorrhage (PPH), admission to the maternal ICU, birth weight, admission to the NICU, and the indication for NICU hospitalization Pregnancy outcomes included mode of delivery, gestational age at delivery, pre-eclampsia, and postpartum hemorrhage (defined as an estimated blood loss of 1,000 mL or greater).
| Study group | Role | What they receive |
|---|---|---|
| Data collection | Data collected included maternal demographics, medication during pregnancy, the gestational week when COVID-19 was diagnosed, antenatal diseases occurring after COVID-19 detection during pregnancy, intrauterine growth retardation (IUGR), small for gestational age (SGA), fetal distress, intrauterine fetal demise (IUFD), intrapartum complications, gestational age (GA) at delivery, mode of delivery, postpartum hemorrhage (PPH), admission to the maternal ICU, birth weight, admission to the NICU, and the indication for NICU hospitalization Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy related complications
Pregnancy related complications as preterm birth, preeclampsia, intrauterine fetal demise (IUFD), increased cesarean section rate, postpartum hemorrhagic gastroenteritis (HGE) were collected
Measured: For one month
Secondary outcomes (4)
Intensive care unit admission rate
Intensive care unit admission rate was collected.
Measured: For one month
Use of mechanical ventilation
Use of mechanical ventilation was collected.
Measured: For one year
Incidence of death
Incidence of death was collected.
Measured: For one month
Apgar score
Apgar score is a quick test performed on a baby at 1 and 5 minutes after birth. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.
Measured: For 5 minutes post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Jan 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
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.
- More trials run by Tanta 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Nabil Ageez, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557694
- Sponsor's protocol ID
- 36264PR750/7/24
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of COVID-19 Infection on Obstertric Complications and Maternal Outcomes
- ClinicalTrials.gov ID
- NCT06557694
- Acronym / sponsor ID
- 36264PR750/7/24
- Conditions
- COVID-19, Infection, Obstetric Complication, Maternal Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 16 Aug 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 study aimed to evaluate the effect of COVID-19 infection on obstetric complications and maternal outcomes.
Detailed description
During the SARS-CoV-2 pandemic, pregnant women were reported to have a higher susceptibility to COVID-19 infection. Pregnant women who tested positive for SARS-CoV-2 are at higher risk of a severe form of COVID-19, associated with higher rates of intensive care unit (ICU) admission and increased needs for respiratory support, compared to the age-matched non-pregnant population.
Women infected during pregnancy also have an increased risk of adverse pregnancy outcomes including preterm-birth, with a significant proportion secondary to iatrogenic preterm birth due to maternal illness. Infection with SARS-CoV-2 during pregnancy has also been reported to be associated with a higher risk of stillbirth directly or indirectly caused by the virus.
Infected pregnant patients tended to present asymptomatically with pre-Delta and Omicron variants, and symptomatically with Delta variant. A previous systematic review suggested that people who are pregnant did not have an increased risk of SARS-CoV-2 infection or symptomatic COVID-19, but they were at risk of severe COVID-19 compared with those who were not pregnant.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data collection | – | Other: Data collectionData collected included maternal demographics, medication during pregnancy, the gestational week when COVID-19 was diagnosed, antenatal diseases occurring after COVID-19 detection during pregnancy, intrauterine growth retardation (IUGR), small for gestational age (SGA), fetal distress, intrauterine fetal demise (IUFD), intrapartum complications, gestational age (GA) at delivery, mode of delivery, postpartum hemorrhage (PPH), admission to the maternal ICU, birth weight, admission to the NICU, and the indication for NICU hospitalization |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This retrospective study was carried out on 260 pregnant women with COVID-19 infection who presented in Tanta University Hospitals in the period from January 2021 to December 2022 with approval from the institutional ethical committee.
Key inclusion criteria (2 listed)
- Age from 18 to 40 years.
- Pregnant women with COVID-19 infection diagnosed either by PCR or rapid test.
Key exclusion criteria (1 listed)
- Patients vaccinated for COVID-19 before or during the 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 |
|---|---|---|
| Data collectionData collected included maternal demographics, medication during pregnancy, the gestational week when COVID-19 was diagnosed, antenatal diseases occurring after COVID-19 detection during pregnancy, intrauterine growth retardation (IUGR), small for gestational age (SGA), fetal distress, intrauterine fetal demise (IUFD), intrapartum complications, gestational age (GA) at delivery, mode of delivery, postpartum hemorrhage (PPH), admission to the maternal ICU, birth weight, admission to the NICU, and the indication for NICU hospitalization Pregnancy outcomes included mode of delivery, gestational age at delivery, pre-eclampsia, and postpartum hemorrhage (defined as an estimated blood loss of 1,000 mL or greater). | Other | Data collection |
Primary outcome
Pregnancy related complications
Time frame: For one month
Pregnancy related complications as preterm birth, preeclampsia, intrauterine fetal demise (IUFD), increased cesarean section rate, postpartum hemorrhagic gastroenteritis (HGE) were collected
4 secondary outcomes
Intensive care unit admission rate
Time frame: For one month
Use of mechanical ventilation
Time frame: For one year
Incidence of death
Time frame: For one month
Apgar score
Time frame: For 5 minutes post-intervention
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 16 Aug 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Infection, run by Tanta 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 2 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: finished, as of the sponsor's last update on 16 Aug 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 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?
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?
Pregnancy related complications (time frame: For one month). 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 16 Aug 2024.