COVID-19 Among Pregnant Women in Assiut

Covid-19 in Pregnancy Clinical Trial

Official title:

COVID-19 Among Pregnant Women in Isolation and Women Hospitals in Assiut

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04822402
• Other study ID #: COVID-19 among Pregnant Women
• Status: Not yet recruiting
• Start date: May 2021
• Est. completion date: June 2022

Study information

• Verified date: March 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. To identify comorbidities that may affect both maternal , fetal and neonatal outcomes .

3. To correlate between COVID-19 infection and maternal, fetal and neonatal outcomes .

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2022
• Est. primary completion date: April 2022
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Pregnant women who are probably or suspected to be infected with COVID-19.

Related Conditions & MeSH terms

• Covid-19 in Pregnancy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (12)

Allotey 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, 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. — View Citation

Blitz MJ, Grünebaum 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. — View Citation

Caparros-Gonzalez RA. [Maternal and neonatal consequences of coronavirus COVID-19 infection during pregnancy: a scoping review]. Rev Esp Salud Publica. 2020 Apr 17;94. pii: e202004033. Review. Spanish. — View Citation

Coronaviridae 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. — View Citation

Goodnight WH, Soper DE. Pneumonia in pregnancy. Crit Care Med. 2005 Oct;33(10 Suppl):S390-7. Review. — View Citation

Hsu 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. Review. — View Citation

Ji 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. Review. — View Citation

Kotlyar 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. — View Citation

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. — View Citation

Penfield 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. — View Citation

Sánchez-Sánchez E, Ramírez-Vargas G, Avellaneda-López Y, Orellana-Pecino JI, García-Marín E, Díaz-Jimenez J. Eating Habits and Physical Activity of the Spanish Population during the COVID-19 Pandemic Period. Nutrients. 2020 Sep 15;12(9). pii: E2826. doi: 10.3390/nu12092826. — View Citation

Silasi 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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	baseline
Secondary	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.	baseline

External Links

•   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)]