N/A
Completed N=881
Understanding COVID-19 Infection in Pregnant Women and Their Babies
Corona Virus Infection · Pregnancy Related · Neonatal Infections · Breastfeeding
Source: ClinicalTrials.gov NCT04703270 ↗
Enrolled (actual)
881
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Antibody Concentrations in Maternal Blood in Pregnant Women in England — 37.2; 7.2; 80.3; 590.5 CAU/ml
Summary
This national study will recruit expectant mothers with and without positive nasopharyngeal swabs for SARS-CoV-2, and aims to determine the seroepidemiology of SARS-CoV-2 amongst expectant mothers and their infants in the U.K.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antibody Concentrations in Maternal Blood in Pregnant Women in England |
37.2; 7.2; 80.3; 590.5 | — |
| PRIMARY Antibody Concentrations in Cord/Infant Blood at Delivery |
35.9; 7.5; 83.9; 549.0 | — |
| SECONDARY Number of Participants With Breastmilk Samples Positive for Antibodies Specific to SARS-CoV-2 |
0; 16; 0 | — |
| SECONDARY Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Blood at Delivery |
— | — |
| SECONDARY Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Secretions at Delivery |
0; 0; 0 | — |
| SECONDARY Breastmilk Samples That Are rtPCR Positive |
— | — |
| SECONDARY Placental Samples That Are rtPCR Positive |
1; 0 | — |
| SECONDARY Number of Participants in Whose Placental Sample the Virus Can be Grown in Vitro |
— | — |
| SECONDARY Number of Participants in Whose Breast Milk Sample the Virus Can be Grown in Vitro |
— | — |
| SECONDARY Number of Mother-baby Pairs in Whom the Virus Can be Grown in Vitro |
— | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent form
- Any woman pregnant in selected hospitals in England who has no signs or symptoms of COVID-19 disease during pregnancy and is rtPCR negative at delivery
- Any woman pregnant in any hospital in England who tests positive by rtPCR at any point during pregnancy from 24 weeks gestation onwards, regardless of signs and symptoms
Exclusion Criteria
- If the pregnant woman is under 18 years in prison or unable to make an informed consent for other reasons (e.g. learning difficulties, language barriers)
Data sourced from ClinicalTrials.gov (NCT04703270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.