Comparison · NCT02757950-f4bc87e3
Exposed Cohort vs Unexposed Cohort: Number of Subjects Reporting Cases of Congenital Anomalies in the Neonates
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Exposed Cohort vs Unexposed Cohort: Number of Subjects Reporting Cases of Congenital Anomalies in the Neonates. Trial comparisons, record NCT02757950-f4bc87e3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02757950-f4bc87e3
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0025 | 0.000851 | 0.00733 | wilson | |
| Risk in group 2 | 0.0175 | 0.0116 | 0.0263 | wilson | |
| Risk difference, group 1 minus group 2 | -0.015 | -0.024 | -0.00734 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.143 | 0.043 | 0.477 | log | |
| Odds ratio, group 1 over group 2 | 0.141 | 0.0421 | 0.472 | log | |
| Number needed to treat, for one fewer participant with the outcome on Exposed Cohort than on Unexposed Cohort | 66.8 | 41.7 | 136 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Exposed Cohort | Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date). | 3 | 1,199 | OG000 |
| Group 2 | Unexposed Cohort | Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy. | 22 | 1,259 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Subjects Reporting Cases of Congenital Anomalies in the Neonates
- Description
Congenital anomalies include morphological, functional, chromosomal or genetic anomalies, regardless of whether detected at birth or not, the foetus is delivered dead or alive, or defects are identified by prenatal ultrasound, amniocentesis or examination of the products of conception.
- Time frame
- From week 27 of pregnancy up to birth
- Population
- Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in.
Source ClinicalTrials.gov
Trial
- Title
- A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.
- NCT number
- NCT02757950
- Phases
- Conditions
- Diphtheria
- Interventions
- Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2019-10-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02757950?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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