Effects of the amount of SARS-CoV-2 in the maternal airways on outcomes before, during, and after childbirth
Not Applicable
Completed
- Conditions
- Effect of SARS-CoV-2 estimated nasopharyngeal viral load on perinatal outcomes in pregnant women affected by COVID-19 during the third trimesterPregnancy and Childbirth
- Registration Number
- ISRCTN11681816
- Lead Sponsor
- Hôpital Antoine-Béclère
- Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36878392/ (added 20/12/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 393
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br>2. Gestational age at the birth measured using patient records<br>3. Birth weight and its Z-score measured using patient records<br>4. 5’Apgar score measured at birth by adequately trained midwives or neonatologists<br>5. Cord pH measured at birth using potentiometric point of care method on cord arterial puncture
- Secondary Outcome Measures
Name Time Method There are no secondary outcome measures