Covid-19 in PregnancyNCT04822402
COVID-19 Among Pregnant Women in Assiut
An observational study of Covid-19 in Pregnancy, run by Assiut University.
Trial summary
COVID-19 is a new disease , little is known about COVID-19 during pregnancy and to the best of our knowledge no published studies in Assiut . Aims of the Research : 1. To describe COVID-19 among pregnant women attending isolation and women hospitals in Assiut . 2. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Covid-19 in Pregnancy
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Jun 2022
- How long will I take part?
- 20 Months
- 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
- Child, Adult, Older adult
Study population: Descriptive cross-sectional study
Who may be able to join
- Pregnant women with confirmed COVID-19 in Isolation hospitals in Assiut recorded and diagnosed by PCR swab from 1/3/2020 until the end of October 2021.
Who cannot join
- Pregnant women who are probably or suspected to be infected with COVID-19.
About this study
Official title: COVID-19 Among Pregnant Women in Isolation and Women Hospitals in Assiut
COVID-19 is a new disease , little is known about COVID-19 during pregnancy and to the best of our knowledge no published studies in Assiut .
Aims of the Research :
- To describe COVID-19 among pregnant women attending isolation and women hospitals in Assiut .
- To identify comorbidities that may affect both maternal , fetal and neonatal outcomes .
- To correlate between COVID-19 infection and maternal, fetal and neonatal outcomes .
Read the detailed description
COVID-19 is the disease caused by a new corona virus on December 2019 in Wuhan, China . On February 2020, the International Committee of Taxonomy of Viruses recognized the etiology of this infection and named it "SARS-CoV-2". World Health Organization (WHO) named the disease COVID-19 , and declared it a pandemic on March 11th 2020 .
Pregnant women are at an increased risk for severe illness from COVID-19 compared to non-pregnant women . Additionally, pregnancy represents a vulnerable period, and this pandemic can negatively impact its outcomes . Therefore, pregnant women may be a group requiring special care in relation to the transmission of SARS-CoV-2 .
The modulations of the maternal immune system in pregnancy may have consequences for the clinical course of COVID-19 , for the treatment and prevention of COVID-19 in pregnancy . In addition to the systemic immunological changes, the reduction in total lung capacity and inability to clear secretions occurring during pregnancy can make pregnant more susceptible to severe respiratory infections .
There are higher levels of circulating coagulation and fibrinolytic factors during pregnancy which may be implicated in the pathogenesis of SARS-CoV-2 infection.
COVID-19 disease has a similar spectrum of symptoms in pregnant woman as in non-pregnant woman . Although most of the symptoms are less frequent during pregnancy but pregnant women are more likely to need admission to an ICU and require invasive ventilation .
Pre-existing maternal comorbidities such as increased maternal age, high body mass index, chronic hypertension and pre-existing diabetes are risk factors for the severity of infection.
The overall data from cohort studies by Allotey et al. , showed 73 deaths (0.63%) in COVID-19 positive pregnant women. The severe form of COVID-19 manifested in 13% of pregnant women, admission to an intensive care unit was required for 4% , 3% required invasive ventilation and 0.4% required extracorporeal membrane oxygenation .
Hsu et al. study on COVID-19 symptom progression during pregnancy compared to non pregnant women showed that 8.3% of the COVID-19 pregnant women had severe disease of whom 86% progressed to a critical stage and were admitted to the ICU , another study by Blitz et al. showed no significant difference between the rates of ICU admission in hospitalized COVID-19 pregnant and non-pregnant COVID-19 positive patients .
Vertical transmission happens if an infected pregnant woman transmits the infection to her fetus / infant during the fetal , intra-partum or post-partum period . Kotlyar et al. in their systematic review and meta-analysis showed a pooled proportion of 3.2% for vertical transmission of COVID-19 infection .
Other studies as Penfield et al. have shown a linkage of vertical transmission with maternal disease severity .
- Conditions
- Covid-19 in Pregnancy
- Keywords
- COVID-19, Pregnancy
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding of the epidemiology of COVID-19 in pregnancy .
The understanding of the epidemiology of COVID-19 in pregnancy will provide critical data about the course of the disease in pregnant women and their infants .
Measured: baseline
Secondary outcomes (1)
Developing a recommendations .
Developing a recommendations relating to antenatal , intrapartum and postpartum care of women in order to help improvement the maternal and neonatal outcomes.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study startMay 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Covid-19 in PregnancyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 20 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Mohamed Mohamed Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822402
- Sponsor's protocol ID
- COVID-19 among Pregnant Women
- Status last verified
- Mar 2021
- First submitted
- 27 Mar 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
PubMed 31995857Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.
PubMed 32123347Sanchez-Sanchez E, Ramirez-Vargas G, Avellaneda-Lopez Y, Orellana-Pecino JI, Garcia-Marin E, Diaz-Jimenez J. Eating Habits and Physical Activity of the Spanish Population during the COVID-19 Pandemic Period. Nutrients. 2020 Sep 15;12(9):2826. doi: 10.3390/nu12092826.
PubMed 32942695Caparros-Gonzalez RA. [Maternal and neonatal consequences of coronavirus COVID-19 infection during pregnancy: a scoping review]. Rev Esp Salud Publica. 2020 Apr 17;94:e202004033. Spanish.
PubMed 32382001Silasi M, Cardenas I, Kwon JY, Racicot K, Aldo P, Mor G. Viral infections during pregnancy. Am J Reprod Immunol. 2015 Mar;73(3):199-213. doi: 10.1111/aji.12355. Epub 2015 Jan 13.
PubMed 25582523Goodnight WH, Soper DE. Pneumonia in pregnancy. Crit Care Med. 2005 Oct;33(10 Suppl):S390-7. doi: 10.1097/01.ccm.0000182483.24836.66.
PubMed 16215363Ji HL, Zhao R, Matalon S, Matthay MA. Elevated Plasmin(ogen) as a Common Risk Factor for COVID-19 Susceptibility. Physiol Rev. 2020 Jul 1;100(3):1065-1075. doi: 10.1152/physrev.00013.2020. Epub 2020 Mar 27.
PubMed 32216698Allotey J, Stallings E, Bonet M, Yap M, Chatterjee S, Kew T, Debenham L, Llavall AC, Dixit A, Zhou D, Balaji R, Lee SI, Qiu X, Yuan M, Coomar D, Sheikh J, Lawson H, Ansari K, van Wely M, van Leeuwen E, Kostova E, Kunst H, Khalil A, Tiberi S, Brizuela V, Broutet N, Kara E, Kim CR, Thorson A, Oladapo OT, Mofenson L, Zamora J, Thangaratinam S; for PregCOV-19 Living Systematic Review Consortium. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. 2020 Sep 1;370:m3320. doi: 10.1136/bmj.m3320.
PubMed 32873575Hsu AL, Guan M, Johannesen E, Stephens AJ, Khaleel N, Kagan N, Tuhlei BC, Wan XF. Placental SARS-CoV-2 in a pregnant woman with mild COVID-19 disease. J Med Virol. 2021 Feb;93(2):1038-1044. doi: 10.1002/jmv.26386. Epub 2020 Nov 10.
PubMed 32749712Blitz MJ, Grunebaum A, Tekbali A, Bornstein E, Rochelson B, Nimaroff M, Chervenak FA. Intensive care unit admissions for pregnant and nonpregnant women with coronavirus disease 2019. Am J Obstet Gynecol. 2020 Aug;223(2):290-291. doi: 10.1016/j.ajog.2020.05.004. Epub 2020 May 7. No abstract available.
PubMed 32387323Kotlyar AM, Grechukhina O, Chen A, Popkhadze S, Grimshaw A, Tal O, Taylor HS, Tal R. Vertical transmission of coronavirus disease 2019: a systematic review and meta-analysis. Am J Obstet Gynecol. 2021 Jan;224(1):35-53.e3. doi: 10.1016/j.ajog.2020.07.049. Epub 2020 Jul 31.
PubMed 32739398Penfield CA, Brubaker SG, Limaye MA, Lighter J, Ratner AJ, Thomas KM, Meyer JA, Roman AS. Detection of severe acute respiratory syndrome coronavirus 2 in placental and fetal membrane samples. Am J Obstet Gynecol MFM. 2020 Aug;2(3):100133. doi: 10.1016/j.ajogmf.2020.100133. Epub 2020 May 8. No abstract available.
PubMed 32391518
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Among Pregnant Women in Isolation and Women Hospitals in Assiut
- ClinicalTrials.gov ID
- NCT04822402
- Acronym / sponsor ID
- COVID-19 among Pregnant Women
- Conditions
- Covid-19 in Pregnancy
- Keywords
- COVID-19, Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 30 Mar 2021 (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.
COVID-19 is a new disease , little is known about COVID-19 during pregnancy and to the best of our knowledge no published studies in Assiut .
Aims of the Research :
- To describe COVID-19 among pregnant women attending isolation and women hospitals in Assiut .
- To identify comorbidities that may affect both maternal , fetal and neonatal outcomes .
- To correlate between COVID-19 infection and maternal, fetal and neonatal outcomes .
Detailed description
COVID-19 is the disease caused by a new corona virus on December 2019 in Wuhan, China . On February 2020, the International Committee of Taxonomy of Viruses recognized the etiology of this infection and named it "SARS-CoV-2". World Health Organization (WHO) named the disease COVID-19 , and declared it a pandemic on March 11th 2020 .
Pregnant women are at an increased risk for severe illness from COVID-19 compared to non-pregnant women . Additionally, pregnancy represents a vulnerable period, and this pandemic can negatively impact its outcomes . Therefore, pregnant women may be a group requiring special care in relation to the transmission of SARS-CoV-2 .
The modulations of the maternal immune system in pregnancy may have consequences for the clinical course of COVID-19 , for the treatment and prevention of COVID-19 in pregnancy . In addition to the systemic immunological changes, the reduction in total lung capacity and inability to clear secretions occurring during pregnancy can make pregnant more susceptible to severe respiratory infections .
There are higher levels of circulating coagulation and fibrinolytic factors during pregnancy which may be implicated in the pathogenesis of SARS-CoV-2 infection.
COVID-19 disease has a similar spectrum of symptoms in pregnant woman as in non-pregnant woman . Although most of the symptoms are less frequent during pregnancy but pregnant women are more likely to need admission to an ICU and require invasive ventilation .
Pre-existing maternal comorbidities such as increased maternal age, high body mass index, chronic hypertension and pre-existing diabetes are risk factors for the severity of infection.
The overall data from cohort studies by Allotey et al. , showed 73 deaths (0.63%) in COVID-19 positive pregnant women. The severe form of COVID-19 manifested in 13% of pregnant women, admission to an intensive care unit was required for 4% , 3% required invasive ventilation and 0.4% required extracorporeal membrane oxygenation .
Hsu et al. study on COVID-19 symptom progression during pregnancy compared to non pregnant women showed that 8.3% of the COVID-19 pregnant women had severe disease of whom 86% progressed to a critical stage and were admitted to the ICU , another study by Blitz et al. showed no significant difference between the rates of ICU admission in hospitalized COVID-19 pregnant and non-pregnant COVID-19 positive patients .
Vertical transmission happens if an infected pregnant woman transmits the infection to her fetus / infant during the fetal , intra-partum or post-partum period . Kotlyar et al. in their systematic review and meta-analysis showed a pooled proportion of 3.2% for vertical transmission of COVID-19 infection .
Other studies as Penfield et al. have shown a linkage of vertical transmission with maternal disease severity .
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 20 Months
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Descriptive cross-sectional study
Key inclusion criteria (1 listed)
- Pregnant women with confirmed COVID-19 in Isolation hospitals in Assiut recorded and diagnosed by PCR swab from 1/3/2020 until the end of October 2021.
Key exclusion criteria (1 listed)
- Pregnant women who are probably or suspected to be infected with COVID-19.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Understanding of the epidemiology of COVID-19 in pregnancy .
Time frame: baseline
The understanding of the epidemiology of COVID-19 in pregnancy will provide critical data about the course of the disease in pregnant women and their infants .
1 secondary outcome
Developing a recommendations .
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Background: PubMed 31995857Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
- Background: PubMed 32123347Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.
- Background: PubMed 32942695Sanchez-Sanchez E, Ramirez-Vargas G, Avellaneda-Lopez Y, Orellana-Pecino JI, Garcia-Marin E, Diaz-Jimenez J. Eating Habits and Physical Activity of the Spanish Population during the COVID-19 Pandemic Period. Nutrients. 2020 Sep 15;12(9):2826. doi: 10.3390/nu12092826.
- Background: PubMed 32382001Caparros-Gonzalez RA. [Maternal and neonatal consequences of coronavirus COVID-19 infection during pregnancy: a scoping review]. Rev Esp Salud Publica. 2020 Apr 17;94:e202004033. Spanish.
- Background: PubMed 25582523Silasi M, Cardenas I, Kwon JY, Racicot K, Aldo P, Mor G. Viral infections during pregnancy. Am J Reprod Immunol. 2015 Mar;73(3):199-213. doi: 10.1111/aji.12355. Epub 2015 Jan 13.
- Background: PubMed 16215363Goodnight WH, Soper DE. Pneumonia in pregnancy. Crit Care Med. 2005 Oct;33(10 Suppl):S390-7. doi: 10.1097/01.ccm.0000182483.24836.66.
- Background: PubMed 32216698Ji HL, Zhao R, Matalon S, Matthay MA. Elevated Plasmin(ogen) as a Common Risk Factor for COVID-19 Susceptibility. Physiol Rev. 2020 Jul 1;100(3):1065-1075. doi: 10.1152/physrev.00013.2020. Epub 2020 Mar 27.
- Background: PubMed 32873575Allotey J, Stallings E, Bonet M, Yap M, Chatterjee S, Kew T, Debenham L, Llavall AC, Dixit A, Zhou D, Balaji R, Lee SI, Qiu X, Yuan M, Coomar D, Sheikh J, Lawson H, Ansari K, van Wely M, van Leeuwen E, Kostova E, Kunst H, Khalil A, Tiberi S, Brizuela V, Broutet N, Kara E, Kim CR, Thorson A, Oladapo OT, Mofenson L, Zamora J, Thangaratinam S; for PregCOV-19 Living Systematic Review Consortium. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. 2020 Sep 1;370:m3320. doi: 10.1136/bmj.m3320.
- Background: PubMed 32749712Hsu AL, Guan M, Johannesen E, Stephens AJ, Khaleel N, Kagan N, Tuhlei BC, Wan XF. Placental SARS-CoV-2 in a pregnant woman with mild COVID-19 disease. J Med Virol. 2021 Feb;93(2):1038-1044. doi: 10.1002/jmv.26386. Epub 2020 Nov 10.
- Background: PubMed 32387323Blitz MJ, Grunebaum A, Tekbali A, Bornstein E, Rochelson B, Nimaroff M, Chervenak FA. Intensive care unit admissions for pregnant and nonpregnant women with coronavirus disease 2019. Am J Obstet Gynecol. 2020 Aug;223(2):290-291. doi: 10.1016/j.ajog.2020.05.004. Epub 2020 May 7. No abstract available.
- Background: PubMed 32739398Kotlyar AM, Grechukhina O, Chen A, Popkhadze S, Grimshaw A, Tal O, Taylor HS, Tal R. Vertical transmission of coronavirus disease 2019: a systematic review and meta-analysis. Am J Obstet Gynecol. 2021 Jan;224(1):35-53.e3. doi: 10.1016/j.ajog.2020.07.049. Epub 2020 Jul 31.
- Background: PubMed 32391518Penfield CA, Brubaker SG, Limaye MA, Lighter J, Ratner AJ, Thomas KM, Meyer JA, Roman AS. Detection of severe acute respiratory syndrome coronavirus 2 in placental and fetal membrane samples. Am J Obstet Gynecol MFM. 2020 Aug;2(3):100133. doi: 10.1016/j.ajogmf.2020.100133. Epub 2020 May 8. No abstract available.
- World Health Organization Press Conference. The World Health Organization (WHO) Has Officially Named the Disease Caused by the Novel Coronavirus as COVID-19. \[(accessed on 11 February 2020)\]Link provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 in Pregnancy, run by Assiut University.
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 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Understanding of the epidemiology of COVID-19 in pregnancy . (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04822402, which also lists 12 linked publications.
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 30 Mar 2021.