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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed | Expectant mothers with a positive nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation regardless of antibody status. | ||
| Seropositive | Expectant mothers with a negative nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation but positive IgM/IgG antibodies against SARS-CoV-2. | ||
| Unexposed | Expectant mothers with a negative nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation and negative IgM/IgG antibodies against SARS-CoV-2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Antibody Concentrations in Maternal Blood in Pregnant Women in England | Antibody concentrations in maternal blood in pregnant women in England: ADCD-S values reported | Delivery |
| Antibody Concentrations in Cord/Infant Blood at Delivery | Cord blood was tested to determine infant antibody levels; where a cord blood sample was not available, a blood sample was taken from the infant instead. ADCD-S assay results are presented. | Delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Breastmilk Samples Positive for Antibodies Specific to SARS-CoV-2 | Number of participants with breastmilk samples positive for antibodies specific to SARS-CoV-2 | At birth |
| Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Blood at Delivery |
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Inclusion Criteria:
Exclusion Criteria:
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All pregnant women ≥ 24 weeks gestation in England.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St George's, University of London | London | SW17 0RE | United Kingdom |
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Participants had their antibodies against SARS-CoV-2 tested prior to assignment of a group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exposed | Expectant mothers with a positive nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation regardless of antibody status. |
| FG001 | Unexposed | Expectant mothers with a negative nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation. |
| FG002 | Vaccinated | Expectant mothers with a negative nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation who received a vaccine against SARS-CoV-2 prior to delivery. |
| FG003 | Vaccinated and Exposed | Expectant mothers with a positive nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation who also received a vaccine against SARS-CoV-2 prior to delivery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exposed | Expectant mothers with a positive nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation regardless of antibody status. |
| BG001 | Unexposed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Antibody Concentrations in Maternal Blood in Pregnant Women in England | Antibody concentrations in maternal blood in pregnant women in England: ADCD-S values reported | Posted | Geometric Mean | Inter-Quartile Range | CAU/ml | Delivery |
|
Over the study period, i.e. until 6 weeks postpartum.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exposed | Expectant mothers with a positive nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation regardless of antibody status. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sarah Sturrock | St George's, University of London | 020 8672 9944 | ssturroc@sgul.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2020 | Nov 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| Delivery |
| Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Secretions at Delivery | Delivery |
| Breastmilk Samples That Are rtPCR Positive | Delivery |
| Placental Samples That Are rtPCR Positive | Delivery |
| Number of Participants in Whose Placental Sample the Virus Can be Grown in Vitro | Delivery |
| Number of Participants in Whose Breast Milk Sample the Virus Can be Grown in Vitro | Delivery |
| Number of Mother-baby Pairs in Whom the Virus Can be Grown in Vitro | 6 weeks post delivery |
Expectant mothers with a negative nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation.
| BG002 | Vaccinated | Expectant mothers with a negative nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation who received a vaccine against SARS-CoV-2 prior to delivery. |
| BG003 | Vaccinated and Exposed | Expectant mothers with a positive nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation who also received a vaccine against SARS-CoV-2 prior to delivery. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Vaccinated |
Expectant mothers with a negative nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation who received a vaccine against SARS-CoV-2 prior to delivery. |
| OG003 | Vaccinated and Exposed | Expectant mothers with a positive nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation who also received a vaccine against SARS-CoV-2 prior to delivery. |
|
|
| Primary | Antibody Concentrations in Cord/Infant Blood at Delivery | Cord blood was tested to determine infant antibody levels; where a cord blood sample was not available, a blood sample was taken from the infant instead. ADCD-S assay results are presented. | Number of participants analysed represents all those for whom a sample was received that was sufficient for analysis with the assay. | Posted | Geometric Mean | Inter-Quartile Range | CAU/mL | Delivery |
|
|
|
| Secondary | Number of Participants With Breastmilk Samples Positive for Antibodies Specific to SARS-CoV-2 | Number of participants with breastmilk samples positive for antibodies specific to SARS-CoV-2 | Most participants did not provide a breastmilk sample of sufficient quantity for analysis. | Posted | Count of Participants | Participants | At birth |
|
|
|
| Secondary | Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Blood at Delivery | No sufficient samples were received to enable rtPCR testing of mother and baby within a pair after sample testing for the primary outcome. | Posted | Delivery |
|
|
| Secondary | Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Secretions at Delivery | All pairs for which a neonatal sample was received for the delivery timepoint were analysed. No delivery secretion samples were taken from neonates in the Unexposed group as per the study protocol. | Posted | Number | Number of mother-infant pairs | Delivery |
|
|
|
| Secondary | Breastmilk Samples That Are rtPCR Positive | No samples were received which were sufficient to allow PCR testing after antibody testing. | Posted | Delivery |
|
|
| Secondary | Placental Samples That Are rtPCR Positive | The population numbers reflect the samples received which were suitable for rtPCR testing. No placental samples were received from participants in the Unexposed or Vaccinated arms, so these were not analysed. | Posted | Number | No. of Placental Samples rtPCR positive | Delivery |
|
|
|
| Secondary | Number of Participants in Whose Placental Sample the Virus Can be Grown in Vitro | All PCR placental samples were negative at delivery, except for one swab which was determined to have likely been contaminated in the delivery room. As all other samples were negative, none proceeded to in vitro culture. | Posted | Delivery |
|
|
| Secondary | Number of Participants in Whose Breast Milk Sample the Virus Can be Grown in Vitro | No breastmilk samples were PCR positive, therefore none proceeded to in vitro culture. | Posted | Delivery |
|
|
| Secondary | Number of Mother-baby Pairs in Whom the Virus Can be Grown in Vitro | No paired samples proceeded to in vitro culture due to lack of PCR positivity. | Posted | 6 weeks post delivery |
|
|
| 0 |
| 173 |
| 0 |
| 173 |
| 0 |
| 173 |
| EG001 | Unexposed | Expectant mothers with a negative nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation. | 0 | 627 | 0 | 627 | 0 | 627 |
| EG002 | Vaccinated | Expectant mothers with a negative nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation who received a vaccine against SARS-CoV-2 prior to delivery. | 0 | 43 | 0 | 43 | 0 | 43 |
| EG003 | Vaccinated and Exposed | Expectant mothers with a positive nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation who also received a vaccine against SARS-CoV-2 prior to delivery. | 0 | 38 | 0 | 38 | 0 | 38 |
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| D007239 |
| Infections |
| D005247 | Feeding Behavior |
| D001519 | Behavior |