Effects of the amount of SARS-CoV-2 in the maternal airways on outcomes before, during, and after childbirth
ISRCTN | ISRCTN11681816 |
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DOI | https://doi.org/10.1186/ISRCTN11681816 |
- Submission date
- 31/10/2021
- Registration date
- 08/11/2021
- Last edited
- 20/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has interested a relevant number of pregnant women worldwide with negative consequences both on the maternal and neonatal side. For instance, COVID-19 is more severe in pregnant women, preterm delivery is more common and neonates have a higher chance to need intensive care admission. Finally, SARS-CoV-2 mother-to-child transmission is possible and neonatal COVID-19 can be observed although rarely. Despite the viral load has been linked to the clinical severity of COVID-19 in non-pregnant patients, the relationship between SARS-CoV-2 viral load and perinatal outcomes in pregnant women affected by COVID-19 in late pregnancy is unknown. We sought to investigate whether or not nasopharyngeal SARS-CoV-2 viral load has any effect on perinatal outcomes, when COVID-19 is diagnosed in the third trimester of pregnancy.
Who can participate?
All women affected by COVID-19 during the third trimester of pregnancy (and not meeting exclusion criteria) were eligible.
What does the study involve?
Patient records from the start of the pandemic to mid-2021 will be analysed.
What are the possible benefits and risks of participating?
The study is retrospective, does not modify the routine care in any way and does not carry any risk for the patients.
Where is the study run from?
Hôpital “A. Béclère” (France)
The study is conducted in four academic tertiary referral perinatal center in major EU and UK cities. These centers have been chosen through contacts between peers for the availability of electronic databases of pregnant women affected by COVID-19 and their expertise on perinatal COVID-19 research.
When is the study starting and how long is it expected to run for?
March 2020 to August 2021
Who is funding the study?
The study has no sponsor of any type and no honorarium is previewed for the participation to the study. Authors are performing the study for free during their worktime and they do not have any conflict of interest to disclose in relation to the project.
Who is the main contact?
Prof. Daniele De Luca, dm.deluca@icloud.com
Contact information
Scientific
Service de Pédiatrie et Réanimation Néonatale
Hôpital “A. Béclère”, GHU Paris Saclay - APHP
157 rue de la Porte de Trivaux
Clamart
92140
France
0000-0002-3846-4834 | |
Phone | +33 (0)145374837 |
DANIELE.DELUCA@APHP.FR |
Public
Service de Pédiatrie et Réanimation Néonatale
Hôpital “A. Béclère”, GHU Paris Saclay - APHP
157 rue de la Porte de Trivaux
Clamart
92140
France
Phone | +33 (0)145374837 |
---|---|
dm.deluca@icloud.com |
Study information
Study design | Multicenter international observational retrospective cohort study |
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Primary study design | Observational |
Secondary study design | Cohort study |
Study setting(s) | Hospital |
Study type | Other |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
Scientific title | Effect of SARS-CoV-2 estimated nasopharyngeal viral load on perinatal outcomes in pregnant women affected by COVID-19 during the third trimester (VALOROUS study) |
Study acronym | VALOROUS |
Study objectives | To verify if maternal viral load in the airways is associated with perinatal outcomes in women affected by COVID-19 in the third trimester of pregnancy. |
Ethics approval(s) | Approved 11/11/2020, Ethical committee of the Department of Women and Newborn Health (Paris Saclay University Hospitals, APHP, Paris, France; +33 0492034409; cppsudmediterraneeV@chu-nice.fr), ref: CPP Sud Méditerranee n.2020-A00924-35 |
Health condition(s) or problem(s) studied | Effect of SARS-CoV-2 estimated nasopharyngeal viral load on perinatal outcomes in pregnant women affected by COVID-19 during the third trimester |
Intervention | Nasopharyngeal swabs will be obtained following US Center for Disease Control and Prevention guidelines. Extraction and amplification will be performed with commercial assays validated for SARS-CoV-2 diagnosis by WHO or local healthcare authorities. Manufacturer’s recommendations will always be followed. The SARS-CoV-2 load will be estimated for any viral gene, according to each laboratory protocol. RT-PCR technique will be performed according to European Center for Disease Prevention and Control. The following data will be collected: basic maternal and neonatal demographics, birth weight Z-score, time between COVID-19 diagnosis and delivery, 5’ Apgar score, cord pH, estimated viral load for any vital gene, COVID-19 severity. These variables were chosen in order to keep a pragmatic design and make from the different centers easy to merge. Data will be collected retrospectively to the start of the pandemic and prospectively to the end of the study. |
Intervention type | Other |
Primary outcome measure | 1. Estimated viral load measured at birth using the number of cycles at the RT-PCR on maternal nasopharyngeal swab according to best microbiological practice 2. Gestational age at the birth measured using patient records 3. Birth weight and its Z-score measured using patient records 4. 5’Apgar score measured at birth by adequately trained midwives or neonatologists 5. Cord pH measured at birth using potentiometric point of care method on cord arterial puncture |
Secondary outcome measures | There are no secondary outcome measures |
Overall study start date | 01/03/2020 |
Completion date | 31/08/2021 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 100 |
Total final enrolment | 393 |
Key inclusion criteria | 1. Third trimester of pregnancy 2. Diagnosis of COVID performed according to World Health Organization criteria 3. Viral load estimated by real-time polymerase chain reaction cycle threshold (Ct) for any viral gene |
Key exclusion criteria | 1. Fetal congenital malformations 2. Major genetic or chromosomal abnormalities 3. Ongoing pregnancies at the time of the analysis 4. Missing viral load or outcome data |
Date of first enrolment | 01/03/2020 |
Date of final enrolment | 31/08/2021 |
Locations
Countries of recruitment
- Belgium
- England
- France
- Italy
- United Kingdom
Study participating centres
Clamart
92140
France
London
SW17 0QT
United Kingdom
Naples
80131
Italy
Brussels
1020
Belgium
Sponsor information
Hospital/treatment centre
DMU Santé Femme et Nouveau-né - Hopital "A.Béclère" - APHP
157 rue de la Porte de Trivaux
Clamart
92140
France
Phone | +33 (0) 1 45 37 44 76 |
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alexandra.benachi@aphp.fr | |
Website | http://www.aphp.fr/contenu/hopital-antoine-beclere-1 |
https://ror.org/04sb8a726 |
Funders
Funder type
Other
No information available
Results and Publications
Intention to publish date | 01/02/2022 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. Presentation in main international congresses in the field of ObGyn and Neonatology |
IPD sharing plan | Anonymous raw data will be available on reasonable request. Data can be asked to investigators in each of the participating centers (for the data contributed by each center). Data will be totally anonymous. A restricted duration of availability and other restrictions may apply according to local regulations enforced in each center. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Protocol file | 02/11/2021 | No | No | ||
Results article | 05/03/2023 | 20/12/2023 | Yes | No |
Additional files
Editorial Notes
20/12/2023: Publication reference added.
02/11/2021: Trial's existence confirmed by Comite de Protection des Personnes Sud Mediterranee