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

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)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN11681816

Enrollment

100

Registered

2021-11-08

Start date

2020-03-01

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of SARS-CoV-2 estimated nasopharyngeal viral load on perinatal outcomes in pregnant women affected by COVID-19 during the third trimester Pregnancy and Childbirth

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
There are no secondary outcome measures	—

Countries

Belgium, England, France, Italy, United Kingdom

Contacts

Public ContactDaniele De Luca

dm.deluca@icloud.com+33 (0)145374837

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026