Effects of the amount of SARS-CoV-2 in the maternal airways on outcomes before, during, and after childbirth

ISRCTN ISRCTN11681816
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Prof Daniele De Luca
Scientific

Service de Pédiatrie et Réanimation Néonatale
Hôpital “A. Béclère”, GHU Paris Saclay - APHP
157 rue de la Porte de Trivaux
Clamart
92140
France

ORCiD logoORCID ID 0000-0002-3846-4834
Phone +33 (0)145374837
Email DANIELE.DELUCA@APHP.FR
Prof Daniele De Luca
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
Email dm.deluca@icloud.com

Study information

Study designMulticenter international observational retrospective cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet.
Scientific titleEffect 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 acronymVALOROUS
Study objectivesTo 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) studiedEffect of SARS-CoV-2 estimated nasopharyngeal viral load on perinatal outcomes in pregnant women affected by COVID-19 during the third trimester
InterventionNasopharyngeal 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 typeOther
Primary outcome measure1. 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 measuresThere are no secondary outcome measures
Overall study start date01/03/2020
Completion date31/08/2021

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants100
Total final enrolment393
Key inclusion criteria1. 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 criteria1. 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 enrolment01/03/2020
Date of final enrolment31/08/2021

Locations

Countries of recruitment

  • Belgium
  • England
  • France
  • Italy
  • United Kingdom

Study participating centres

Department of Women and Newborn Health, Medical Center A. Béclère, Paris Saclay University Hospitals, APHP
157, Rue de la porte de Trivaux
Clamart
92140
France
Fetal Medicine Unit, Saint George's Hospital
Blackshaw Road
London
SW17 0QT
United Kingdom
Department of Translational Medical Sciences, University of Naples Federico II
5, Via Sergio Pansini
Naples
80131
Italy
Department of Obstetrics and Gynecology, Brugmann University Hospital, Université Libre de Bruxelles
4, Place A. Van Gehuchten
Brussels
1020
Belgium

Sponsor information

Hôpital Antoine-Béclère
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
Email alexandra.benachi@aphp.fr
Website http://www.aphp.fr/contenu/hopital-antoine-beclere-1
ROR logo "ROR" https://ror.org/04sb8a726

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/02/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal. Presentation in main international congresses in the field of ObGyn and Neonatology
IPD sharing planAnonymous 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?
Protocol file 02/11/2021 No No
Results article 05/03/2023 20/12/2023 Yes No

Additional files

40604 protocol.pdf

Editorial Notes

20/12/2023: Publication reference added.
02/11/2021: Trial's existence confirmed by Comite de Protection des Personnes Sud Mediterranee