Disease Registry for Pregnant Women With Suspected COVID-19 or Confirmed SARS-CoV-2 and Their Neonates.
Conditions: COVID-19, Pregnant Women
Sponsor: Hamad Medical Corporation

HMC RESEARCH 
PROTOCOL  
Page 1 of 14 
Study Title: Qatar PREgnancy CovId OUtcome Study (Q-PRECIOUS) 
Principal 
Investigator: 
Dr. Salwa Abu Yaqoup, Sr. Consultant and Obstetric chair 
Contents 
1.
Synopsis ........................................................................................................................... 2 
2.
Abbreviations and Acronyms ............................................................................................ 2 
3.
Introduction / Background ................................................................................................. 2 
4.
Objectives ......................................................................................................................... 5 
5.
Indicate if this is a retrospective data review ..................................................................... 5 
6.
Study Methodology ........................................................................................................... 5 
7.
Study Population and Study Setting/ Location .................................................................. 7 
8.
Study procedures .............................................................................................................. 7 
   Study Duration and Timelines ........................................................................................... 7 
   Informed Consent ............................................................................................................. 8 
   Risk ................................................................................................................................... 9 
   Bio-Specimens & Sample Collection ................................................................................. 9 
   Outcomes .......................................................................................................................... 9 
   Data Collection, Data Management & Confidentiality ..................................................... 10 
   Subject Withdrawal/ Withdrawal of Consent ................................................................... 11 
9.
Statistical Consideration and Data Analysis .................................................................... 11 
10.
Adverse Event Reporting ............................................................................................. 12 
11.
Ethical Consideration ................................................................................................... 12 
12.
Sponsor, Funding & Collaborator Information .............................................................. 12 
13.
Dissemination of Results and Publication policy .......................................................... 12 
14.
References .................................................................................................................. 12 
15.
Appendices .................................................................................................................. 14
NOTE: After completion, kindly delete the instructions provided beneath each section. 
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1. Synopsis 
In this section provide a brief summary of the research study (250-300 words). 
The synopsis consists of 1-2 sentences of background, then a concise objective for the research followed by a brief 
description of research participants, interventions, methods, data collected and proposed analysis ending with the 
anticipated outcome(s).  
Someone who knows nothing about the research should be able to get a clear snap shot of the proposed research and 
intended outcome. 
 
      
 
 
2. Abbreviations and Acronyms 
List abbreviations, acronyms and terms of reference used in the protocol; provide definitions for each as needed 
SARS-CoV-2 
suspected COVID-19: they have symptoms but have not been tested/awaiting test results/tested 
negative 
confirmed SARS-CoV-2 infection: tested positive for SARS-CoV-2 
 
 
3. Introduction / Background 
Introduction  
The coronavirus disease 2019 or ‘COVID-19’ is respiratory tract infection caused by the novel 
coronavirus strain initially  (1). On 12th March 2020, the World Health Organization declared it as a 
‘pandemic’ outbreak of utmost international concern. Majority of the published evidence have 
originated from China, where the first coronavirus patient was identified in the Wuhan City in December 
2019 (2,3). Previous emerging infections such as, H1N1 influenza virus, Zika virus, severe acute 
respiratory syndrome corona virus (SARS-CoV) and Middle East respiratory syndrome corona virus 
(MERSCoV) have shown to have significant impact on maternal as well as perinatal outcomes (4,5).  
Epidemiology, transmission and symptoms  
Ever since the first case report in China, the infection has been growing at an accelerating pace and 
has spread across nearly 213 countries worldwide, infecting over 2.8 million people, resulting 206,018 
deaths worldwide (as of 26th April 2020)(6). The reported prevalence ranges from 13% at two medical 
centers in the United States to 43.5% confirmed cases reported during a joint mission by the World 
Health Organization at Wuhan province in China.  
While a vast majority of cases were categorized as mild or uncomplicated, almost 14% of the patient 
required hospitalization and/or oxygen support and approximately 5% needed an intensive care 
admission to survive (7). Common clinical manifestations reported among hospitalized patients were 
 
 
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fever (83-100%), cough (59-82%), myalgia (11-35%), headache (7-8%), and diarrhea (2-10%). All 
patients had an abnormal radiographic chest imaging (3,8,9).  
The two routes by which COVID-19 can be spread is through close contact with an infected person 
wherein the respiratory secretions are transmitted through the eyes, mouth, nose or airways. The 
second route of transmission is by touching one’s own mouth, nose or eyes after touching the surface, 
object or the hand of an infected person contaminated with respiratory secretions (10).   
 
National Institutes of Health in the United States has classified the disease severity based on the 
following symptoms,  
Severity 
Symptoms 
Asymptomatic 
Positive test for SARS-CoV-2 but no symptoms 
Mild illness 
Any signs and symptoms (eg, fever, cough, sore throat, malaise, 
headache, muscle pain) without shortness of breath, dyspnea, or 
abnormal chest imaging. 
Moderate illness Evidence of lower respiratory disease by clinical assessment or 
imaging and a saturation of oxygen (SaO2) >93 percent on room air 
at sea level. 
Severe illness 
Respiratory frequency >30 breaths per minute, SaO2 ≤93 percent 
on room air at sea level, ratio of arterial partial pressure of oxygen to 
fraction of inspired oxygen (PaO2/FiO2) <300, or lung infiltrates >50 
percent. 
Critical illness 
Respiratory failure, septic shock, and/or multiple organ dysfunction. 
 
COVID-19 and its impact on pregnancy 
The obstetrical population is considered vulnerable. Pregnancy involves multiple interactions with the 
health care system and eventually all are admitted to the hospital for delivery, therefore, managing 
pregnant population presents a unique challenge during this pandemic. Additionally, the physiological 
changes and partial immune suppression during pregnancy makes the pregnant women and newborn 
babies susceptible to several infections. Post-partum hemorrhage, maternal sepsis, preeclampsia, 
premature rupture of membrane are the most common adverse events reported to have caused by this 
disease in pregnant women (11).  
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There are currently limited data on fCOVID-19 infections during pregnancy. Anecdotal evidence 
suggests that pregnant women do not appear to be different than the general population in terms of 
disease transmission. In addition, neonatal vertical transmission has been suspected in a neonate of a 
COVID-19 positive mother (12). Recently, poor maternal and neonatal outcomes including critical care 
admission, preterm normal and cesarean delivery, premature rupture of the membrane or PROM , fetal 
distress, stillbirth, and multiple organ dysfunction (1,11,13-17). 
Importance of Registry  
From the limited information gathered about the novel coronavirus, its impact on pregnancy and 
newborn and the drastically increasing burden of the disease, it is vital that scientific information 
concerning the disease is collected and shared in a concise and practical manner. Hence, there is a 
need to collect case data rapidly, to pool global data on the natural history of women affected by 
suspected COVID-19 or confirmed SARS-CoV-2 in pregnancy to inform treatment and implement 
preventative strategies in this and future outbreaks. A centre-based registry, gathering case data 
prospectively on the effect of SARS-CoV-2 infection from healthcare systems around the world offers a 
method to accrue clinical outcomes on key research questions from a variety of populations and the Q-
PRECIOS register will serve such purpose. 
 
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4. Objectives 
In this section provide a clear statement of the primary and any secondary objectives of the study 
The main aim of this study is to understand the natural course of the COVID-19 infection during 
pregnancy and postnatal period. To this end the registry objective are to: 
1. To form a disease registry linked with other national data sources for women with suspected 
COVID-19 or confirmed SARS-CoV-2 in pregnancy and their neonates. 
1.1 Study the course of COVID-19 disease i.e. its symptoms, duration, progression in pregnant 
women 
1.2 Study the pregnancy, postnatal and neonatal effect of COVID-19 disease 
Objective justification 
The in-utero exposure of acute viral infection in some instances is proven to have short- and 
long-term neonatal effect during the postnatal and childhood period and the Zika virus, 
measles, mumps and rubella are few examples. COVID-19 is caused by a novel coronavirus 
strain of unknown consequences. The main purpose of this registry is to collect a baseline 
data and help establishing future studies and hypothesis generation.  
In addition, we will be exploring the psychological impact of COVID-19 on women during the 
pregnancy and postnatal period. Stress and anxiety level are increased with potential 
adverse pregnancy and/or neonatal outcomes especially during infectious disease outbreak. 
In fact, COVID-19 is associated with adverse maternal and neonatal outcomes resulting in 
increased level of stress and anxiety. In addition, women during the pregnancy, peripartum, 
and postpartum period are at increased risk of depression. A risk that has been aggravated 
by social and physical isolation. Indeed, the social and physical isolation, a critically needed 
measure to stop the virus transmission, resulted in increased stress and depression level 
and adversely affecting the mental and physical health of both the mother and the baby. 
 
5. Indicate if this is a retrospective data review 
 
• 
   Retrospective Chart/data Review  
 
• 
 Provide the date range of the chart review  
6. Study Methodology  
 
This is a nationwide prospective observational registry linked with PAN-COVID UK register of pregnant 
women with suspected and/or confirmed diagnosis of COVID-19 infection. The enrollment period for 
this registry is 2 years e.g. May 1, 2020 to May 1st, 2022. Case reports or cases diagnosed ever since 
27th Feb will also be included. The authors of published case reports will be contacted for permission. 
This registry will open for enrollment after IRB/MRC approval. Understanding the effect of COVID-19 
infection on pregnancy and its outcome is imperative to help the patients and healthcare providers 
understand the impact of the disease on the pregnant women and their offspring. There is no 
intervention planned in this study, therefore, there is a minimal risk associated with this study. 
 
 
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Data collection: 
Objective 1: To form a disease registry linked with other national data sources for women with 
suspected COVID-19 or confirmed SARS-CoV-2 in pregnancy and their neonates. 
Objective 1.1: Study the course of COVID-19 disease i.e. its symptoms, duration, progression in 
pregnant women 
Objective 1.2: Study the pregnancy and neonatal effect of COVID-19 disease  
We will collect information about patient demographic, co-morbidities, clinicopathological 
information, COVID-19 disease sign, symptoms and its treatment, pregnancy and neonatal 
outcomes, and women mental health during pregnancy and postnatal period. Regarding pregnancy 
outcomes, our study will focus on miscarriage, fetal growth restriction and stillbirth, pre-term delivery 
and vertical transmission and will include fields on ultrasound diagnosis and neonatal care (for 
details refer to appendix 1, 2 and 3). The woman and her neonate(s) will be followed for 1 year 
postnatally. Regarding the neonatal outcomes, outlined in the neonatal outcome data collection 
sheet, includes birth weight, congenital malformations, APGAR score, Breastfeeding, COVID-19 
status, respiratory symptoms, neonatal status, and discharge status. 
Baseline characteristic and initial assessment will be done during the hospital admission up on COVID-
19 diagnosis. Apart from that, there are 7-10 expected follow up telephone calls or online forms to be 
sent to the patient. The schedule and timeline of data/biospecimen collection are described in table 1. 
  
Data Collection Form 
or Questionnaire 
Baseline 
Weekly 
for 4 
weeks 
2nd Trimester 
(GA 24 
weeks) 
3rd Trimester 
(GA 34 
weeks) 
GA 36 
weeks 
GA 38 
weeks 
6 weeks 
postpartum 
6 
Months 
12 
Months 
Demographics, 
Health History and 
COVID-19 Questions 
X 
 
 
 
 
 
 
 
 
COVID-19 Symptoms 
Follow-up 
 
X 
X 
X 
 
 
X 
X 
X 
Pregnancy 
Status/Outcomes 
 
X 
X 
X 
X 
X 
X 
 
 
Depression and 
Anxiety* 
X 
 
X 
X 
 
 
X 
X 
X 
Neonatal/Infant 
Outcomes 
 
 
 
 
 
 
X 
X 
X 
*Generalized Anxiety Disorder 7-item (GAD-7) scale and Edinburgh Postnatal Depression Scale (EPDS) 
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7. Study Population and Study Setting/ Location 
We will include all pregnant patients with suspected or confirmed COVID-19 infection at all HMC 
facilities including WWRC, CH, AKH, AWH and its associated quarantine sites and their offspring’s. 
The inclusion criteria are: 
1. pregnant woman with suspected or confirmed SARS-CoV-2 infection 
2. postpartum women who delivered during the last six weeks and 
3. neonate(s) of women included in the registry.  
We will also contact corresponding authors of case reports of women with COVID-19 from February 
2020 for their written consent, by email, for inclusion of the data from these reports in the PAN-COVID 
register. 
Sample size calculation: 
Based on a recently published study, 15% of pregnant women were SARS-CoV-2 positive. Out of 
which only 12% (1.9% of total study patients) were symptomatic. The total number of deliveries per 
year in Qatar is between 19000 – 21000 deliveries (1650 patients/month). Diagnosis of COVID-19 in 
Qatar is based on selective criteria i.e. presenting with symptoms, recent travel to endemic area or 
contact with a confirmed case. However, all women undergoing cesarean section are screened. 
Therefore and based on 95% CI and 0.05 margin of error, we anticipate a total 170 - 200 case per 
month. 
 
8. Study procedures  
Study Duration and Timelines 
This registry is expected to enroll patients for 2 years and follow them up to 1 year postnatally i.e. the 
registry duration will approximately last for 4 years. 
Study timeline: 
Patient enrollment: 2 years 
Data collection and curation: 4 years 
Study visit numbers: 7-10 visits (see details below); Initial patient visit is expected to last for 30 
minutes.  
1. baseline, 
2. weekly for 4 weeks, 
3. At 24 – 34 – 36 – 38 weeks of gestation (provided that baseline and the 4 weekly follow up 
occurred earlier),  
4. At 6 weeks, 6 and 12 months postpartum (for both mother and the baby) 
Further to that, the first visit “baseline” will be collected by the primary physician who is taking care of 
the participating patient. All subsequent visits will be over the phone with mother. Telephone calls for 
follow up visit are expected to last 15 – 30 minutes. 
Data analysis: interim and final 
Final report: 2 months 
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Study procedure: 
Suspected patient or patients with positive COVID results will be identified through Cerner. Patients will 
then be contacted trough the primary physician to explain the study and obtain consent forms once 
accepted. The primary physician will then collect demographic and baseline data after obtaining patient 
consent (appendix 1 & 2). Apart from the initial visit, there is no anticipated future study visits. Data 
collection will be either through the phone or using a self-administered survey that will be sent through 
SMS. 
The maximum follow-up period is 2 years. Based on the gestational age at time of enrolment might 
vary e.g. if the patient was enrolled early in pregnancy e.g. during the first trimester, the enrollment 
period will be for 2 years whilst patient who is enrolled in third trimester will be enrolled for less than 2 
years. 
During the follow up, patient will be contacted over the phone. 
Further, we aim to collected data about psychological status i.e. depression and anxiety disorders 
using the depression Edinburgh Postnatal Depression Scale (EDPS) and the Generalized Anxiety 
Disorder 7 (GAD-7) surveys. Both surveys, the EDPS and GAD-7, are self-administered surveys that 
will be sent through an SMS link to the subject. In case patient was identified as having depression or 
anxiety disorder, the patient will be referred to contact the national mental health helpline at 16000. In 
case the study team is concerned about the mental health of the subject a direct referral will be sent 
through Cerner and psychiatrist will be consulted. 
Informed Consent 
a) How people will be NOTIFIED OR APPROACHED to consider being a research subject in this study? 
Patient will be notified through: 
1. Advertisements such as hospital posters and social media. In this case, filling the study 
online form will be considered as a patient consent. 
2. Referral through the primary physician. In this case, the primary physician will explain the 
study to the patient and document her willingness to participate in Cerner.  
b) Describe the CONSENT PROCESS procedures (When, Where, How, by Whom). 
When an eligible patient is referred by her primary physician, a study coordinator will follow-up by 
phone to explain the study and obtain a verbal consent to release medical information. In case of 
self-referral, through filling the online form or calling the study coordinator, a study coordinator will 
follow with a phone call to explain the study and obtain a verbal informed consent. 
c) Describe HOW LONG potential participants will have to decide on participation. 
The patient will be given a 24-hour period to decide.  
d) Describe how subjects will be SCREENED FOR ELIGIBILITY for the study. 
Patients will be screened based on a confirmatory laboratory result of a positive SARS-CoV-2 
PCR results. 
e) Describe how subjects will be ENROLLED into the research study below. 
Once the laboratory result is confirmed and verbal consent is obtained, patient details will be 
entered into the online study database and given a study number. 
 
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Risk 
The is a prospective observational registry. There minimal risk of breach of patient confidentiality. To 
minimize this risk, data will be entered into an electronic registry software. The software will be secured 
with username and password and only accessible by the study investigators for data entry. Data 
extraction will only be accessible to study PIs and co-PIs. Paper based data collection sheet will be 
secured in locked cabinets accessible only by study PIs and co-PIs. Only de-identified data will be 
shared amongst investigators. If a breach in confidentiality occurs, the IRB will be notified immediately. 
Consent form containing the linking information between collected data and patient’s identifiable 
information will be stored in a locked cabinet and/or password locked computer. Information on the 
password protected computer database will only be accessed by the investigators. Furthermore, the 
PI’s office will remain locked. All study documentation will be stored according to the MRC guidelines 
Bio-Specimens & Sample Collection 
NA 
Outcomes 
We believe the results of this study will generate robust data. Prevalence of SARS-CoV-19 infection in 
pregnancy. Percentage and distribution of COVID-19 presenting sign and symptoms. Percentage of 
adverse pregnancy and neonatal outcomes. Description of mental status of pregnant women affected 
by COVID-19 infections. 
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Data Collection, Management & Confidentiality  
 
a) Indicate below HOW study data will be collected for the proposed research. 
 
 Study Forms    
 Study Database     
 Study Web-Based/App    
 Other       
 
Please detail how study data will be coded: 
Once informed consent is obtained, patient will be given study number and entered in the registry 
system. Data will be stored registry database/web-portal password protected on Cerner. Only study 
investigators have access for data entry. For follow up purposes, study investigators will have 
access to the identifiable information during the data collection period.  No individual identity will be 
disclosed in results and publications.  
 
b) Describe below WHERE and HOW the study data is physically stored. 
In case paper-based document, such as signed informed consent, and CRFs, are used it will be stored 
in locked cabinets. Excel file containing patient identifiable information will be password protected. 
Electronic CRF (eCRF) will be developed by HMC Cerner team. The requirement for QPRECIOUS 
forms and feasibility has been discussed with HMC Cerner team (table 2). The forms will be stored on 
the patient’s files with access control and confidential status to prevent form access and edit. 
This has already been discussed with HICT/Cerner team through Dr. Shamsa Ahmad, informatics lead 
at WWRC, coinvestigator in the study and Ob/Gyn consultant (below is the timeline of suggested 
milestones). For the purpose of this registry, the case report forms will be built in Cerner. The data will 
be store on central repository. The access of which will be controlled by the study PI and co-PI. To 
ensure the highest quality, the data will be reviewed by certain study members. The findings of this 
review along with other KPIs will be presented in the regular meeting of the study steering committee. 
 
Table 2 – Data collection form build on Cerner milestones 
S. No 
Activity 
Owner 
Comments 
1. 
Workflow finalization and users [ nurses? 
Physician obgyn? who will fill the forms, when 
the forms are filled, which facilities it is used, 
Clinic setup required or not], to discuss with 
Graham – HICT CT team and SMEs 
Saji/ Hima  
To check with 
Graham 
availability for 
meeting 
2. 
Include RACS team and pursue their 
approval from Facility with in WWRC 
Dr Shamsa / Mr Gasim 
to discuss with RACS 
team on approval for 
forms to be designed 
Share approvals 
with RACS 
document 
number for the 
forms 
3 
Log a change request in E service.hamad.qa 
Dr Shamsa / Mr Gasim 
Share interaction 
with Saji/ Hima/ 
Paul 
4. 
Review and analyze the forms 
HICT Team 
2 persons – 3 
days tentative 
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5 
Confirmation regarding the MRC approval for 
study   
Dr Shamsa/ Mr Gasim 
 
6 
Building the forms on CERNER on CERT 
environment  
Cerner 
2 weeks 
7 
Validation of Forms on CERT environment  
HICT and SMEs 
3 days 
8 
Issue resolution and revalidation  
Cerner- HICT 
2 days 
9 
Building the forms on CERNER on PROD 
environment  
Cerner 
2 weeks 
10 
Validation of Forms on PROD environment – 
HICT and Team 
HICT- SMEs 
3 days 
11 
Go Live support 
HICT 
1 day 
 
c) Describe below WHO controls access to the study data 
Study PI and Co-PIs combined will control access to study data. Data access request must be 
written and signed by two members. 
 
d) Describe below WHO has access to the study data. 
Data entry level: 
Data collection/entry: HMC physicians will be eligible to enter patient initial assessment form. Follow 
up data study investigators and research coordinators will have access to enter patient data into the 
database. 
Data extraction for audit, analysis, report and request of collaboration: 
Data extraction access will be granted to specified personnel designated by the register steering 
committee.  
 
e) Describe below HOW the study data is accessed. 
Level access will be employed from HMC Cerner team. Study data will be accessed using a 
dedicated username and password for specified members. 
 
f) Will subject identifiers be shared outside of HMC? If YES describe below WHOM the study data is shared 
No, only deidentified data will be shared. 
 
 
Subject Withdrawal/ Withdrawal of Consent 
In case patient wish to be withdrawn from the study, no further contact will be made. However, 
collected information up to the point of withdrawal will be included in the analysis. Subjects withdraw 
from the study will be asked whether they are willing to allow ongoing data collection and his response 
will be recorded. 
 
 
9. Statistical Consideration and Data Analysis 
 
Descriptive data: Numerical data will be presented as mean and standard deviation where 
normally distributed or median and range where it’s not normally distributed. Categorical data 
 
 
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will be presented as frequency and percentages. Prevalence of COVID-19 will be calculated as total 
number of patients who were positive over total number deliveries in the same month. Inferential 
analysis will be used to assess association and tests will be selected according to suitability.  
10. Adverse Event Reporting 
This is an observation study. There are no anticipated adverse events. 
 
 
11. Ethical Consideration. 
The registry will only commence after obtaining approval from IRB/HMC an in accordance with good 
clinical practice, and MoPH regulations 
 
 
12. Sponsor, Funding & Collaborator Information  
MRC 
 
13. Dissemination of Results and Publication policy 
Once the project is funded, the study team will initiate monthly meetings to discuss study plans 
and patient recruitment. Team leaders will also meet monthly to share study updates. 
Furthermore, the study results will be shared among peers in the department through 
presentation of study findings. Finally, once the study is completed, we aim to present our 
finding at the Hamad Medical Corporation Annual Research Day, local and international 
conferences and in peer-reviewed journals. 
 
 
14. References  
(1) Sohrabi C, Alsafi Z, O’Neill N, Khan M, Kerwan A, Al-Jabir A, et al. World Health Organization 
declares global emergency: A review of the 2019 novel coronavirus (COVID-19). International Journal 
of Surgery. 2020; . 
(2) World Health Organization. WHO Director-General's opening remarks at the media briefing on 
COVID-19-11 March 2020. Geneva, Switzerland. 2020; . 
(3) Guo Y, Cao Q, Hong Z, Tan Y, Chen S, Jin H, et al. The origin, transmission and clinical therapies 
on coronavirus disease 2019 (COVID-19) outbreak–an update on the status. Military Medical 
Research. 2020; 7(1):1-10. 
(4) Moore CA, Staples JE, Dobyns WB, Pessoa A, Ventura CV, Da Fonseca EB, et al. Characterizing 
the pattern of anomalies in congenital Zika syndrome for pediatric clinicians. JAMA pediatrics. 2017; 
171(3):288-295. 
(5) Rasmussen SA, Jamieson DJ, Honein MA, Petersen LR. Zika virus and birth defects—reviewing 
the evidence for causality. New England Journal of Medicine. 2016; 374(20):1981-1987. 
(6) The World Health Organisation. Coronavirus disease (COVID-19) Pandemic. [homepage on the 
Internet]. World Health Organisation; 2020 [updated April/26; cited 2020 April/26]. Available from: 
https://www.who.int/emergencies/diseases/novel-coronavirus-2019. 
 
 
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(7) Surveillances V. The epidemiological characteristics of an outbreak of 2019 novel coronavirus 
diseases (COVID-19)—China, 2020. China CDC Weekly. 2020; 2(8):113-122. 
(8) Adhikari SP, Meng S, Wu Y, Mao Y, Ye R, Wang Q, et al. Epidemiology, causes, clinical 
manifestation and diagnosis, prevention and control of coronavirus disease (COVID-19) during the 
early outbreak period: a scoping review. Infectious diseases of poverty. 2020; 9(1):1-12. 
(9) Lai C, Shih T, Ko W, Tang H, Hsueh P. Severe acute respiratory syndrome coronavirus 2 (SARS-
CoV-2) and corona virus disease-2019 (COVID-19): the epidemic and the challenges. International 
journal of antimicrobial agents. 2020; :105924. 
(10) Mullins E, Evans D, Viner R, O'Brien P, Morris E. Coronavirus in pregnancy and delivery: rapid 
review. Ultrasound in Obstetrics & Gynecology. 2020; . 
(11) The Royal College of Obstetricians and Gynaecologists (RCOG). Coronavirus (COVID-19) 
Infection in Pregnancy. London, United Kingdom: Royal College of Obstetricians and Gynaecologists; 
2020. 
(12) Alzamora MC, Paredes T, Caceres D, Webb CM, Valdez LM, La Rosa M. Severe COVID-19 
during Pregnancy and Possible Vertical Transmission. American Journal of Perinatology. 2020; . 
(13) Karami P, Naghavi M, Feyzi A, Aghamohammadi M, Novin MS, Mobaien A, et al. Mortality of a 
pregnant patient diagnosed with COVID-19: A case report with clinical, radiological, and 
histopathological findings. Travel Medicine and Infectious Disease. 2020; :101665. 
(14) Liu Y, Chen H, Tang K, Guo Y. Clinical manifestations and outcome of SARS-CoV-2 infection 
during pregnancy. The Journal of infection. 2020; . 
(15) Chen H, Guo J, Wang C, Luo F, Yu X, Zhang W, et al. Clinical characteristics and intrauterine 
vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of 
medical records. The Lancet. 2020; 395(10226):809-815. 
(16) Wang1a X, Zhou2a Z, Zhang J, Zhu F, Tang Y, Shen X, et al. A case of 2019 Novel Coronavirus 
in a pregnant woman with preterm delivery. Clin Infect Dis. 2020; . 
(17) Zhu H, Wang L, Fang C, Peng S, Zhang L, Chang G, et al. Clinical analysis of 10 neonates born 
to mothers with 2019-nCoV pneumonia. Translational pediatrics. 2020; 9(1):51. 
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15. Appendices 
• Appendix 1: QP_demographics 
• Appendix 2: QP_History-COVID symptoms 
• Appendix 3: QP_COVID19_FU 
• Appendix 4: QP_Pregnancy follow up 
• Appendix 5: QP_Pregnancy outcomes 
• Appendix 6: QP_Neonatal outcomes 
• Appendix 7: Edinburgh Postnatal Depression Scale (EPDS) 
• Appendix 8: Generalized Anxiety Disorder 7-item (GAD-7) scale 
• Appendix 9: Budget sheet 
• Appendix 10: scheme of delegations 
 
 
 
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