Trial · NCT02757950
A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.
NCT02757950, Completed, GlaxoSmithKline; results first posted 2019-10-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil. Trials, record NCT02757950. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02757950
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- Status
- Completed
- Enrollment
- 2,462 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Diphtheria
- Interventions
- Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]
- First posted
- 2016-05-02
- Last updated
- 2019-10-01
- Results first posted
- 2019-10-01
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Reporting Gestational Diabetes | After week 27 of pregnancy | Gestational diabetes was defined as: Onset or first recognition of abnormal glucose tolerance during pregnancy (the diagnosis is based on administration of glucose challenge test at 24-28 weeks of gestation). Includes Class A1: Euglycaemia achieved with diet and/or exercise and Class A2: Euglycaemia achieved with medication. |
| Primary | Number of Subjects Reporting Pregnancy-related Hypertension, Pre-eclampsia, Eclampsia, and HELLP Syndrome | After week 27 of pregnancy | Pregnancy-related hypertension is defined as: Blood pressure systolic higher than (\>) 140 and/or diastolic \> 90 millimetre of mercury (mmHg), documented in at least two separate measurements after 20 weeks of gestation, without proteinuria or other stigmata of pre-eclampsia, and returning to normal post-partum. Hypertension usually resolves by 12 weeks post-partum, included pre-eclampsia, eclampsia and haemolysis elevated liver enzymes low platelet (HELLP) Syndrome for this study. |
| Primary | Number of Subjects Reporting Pregnancy Hemorrhage | After week 27 of pregnancy | Pregnancy vaginal hemorrhage is defined as: excessive blood loss after delivery i.e. estimated blood loss in excess of 500 milliliters (ml) after vaginal delivery and estimated blood loss in excess of 1000 ml after Caesarean delivery. The other symptoms are higher than or equal to (≥) 10 percent (%) drop in hematocrit, need for blood transfusion, symptomatic hypotension, dizziness, pallor and oliguria. Vaginal or intrauterine hemorrhage that encompasses antepartum (i.e. bleeding from the genital tract after 24 weeks of gestation), intrapartum, and postpartum bleeding (i.e. within 24 hours post-delivery). A major obstetric hemorrhage is defined as blood loss from uterus or genital tract \>1500 ml or a decrease. |
| Primary | Number of Subjects With Pre-specified Neonate-related Outcomes Resulting in Preterm Birth | From week 27 up to week 37 of pregnancy | Preterm birth is defined as: Birth before 37 weeks of gestation. |
| Primary | Number of Subjects With Pre-specified Neonate-related Outcomes, Resulting in Neonates Small for Their Gestational Age | After week 27 of pregnancy | Small for gestational age is defined as: Birth weight less than (\<) 10% for infants of same gestational age and gender in same population. |
| Secondary | Number of Subjects Reporting Pregnancy-related Adverse Events (AEs) of Interest/Neonate-related Events up to Delivery | After week 27 of pregnancy | Pregnancy-related AEs of interest and neonate-related events are defined as: premature rupture of membranes, preterm premature rupture of membranes, premature uterine contraction, neonatal death, maternal death, still birth, neonatal hypoxic ischaemic encephalopathy. |
| Secondary | Number of Subjects Reporting Cases of Congenital Anomalies in the Neonates | From week 27 of pregnancy up to birth | 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. |
| Secondary | Number of Subjects With Pregnancy-related AEs and Birth Outcomes Per Calendar Year | After week 27 of pregnancy | Pregnancy related AEs include: gestational diabetes, pregnancy-related hypertension, pre-eclampsia, eclampsia, HELLP Syndrome and pregnancy hemorrhage. Birth outcomes include: preterm birth and small for gestational age. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Reporting Gestational Diabetes | After week 27 of pregnancy | Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects Reporting Pregnancy-related Hypertension, Pre-eclampsia, Eclampsia, and HELLP Syndrome | After week 27 of pregnancy | Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects Reporting Pregnancy Hemorrhage | After week 27 of pregnancy | Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Pre-specified Neonate-related Outcomes Resulting in Preterm Birth | From week 27 up to week 37 of pregnancy | Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Pre-specified Neonate-related Outcomes, Resulting in Neonates Small for Their Gestational Age | After week 27 of pregnancy | Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reporting Pregnancy-related Adverse Events (AEs) of Interest/Neonate-related Events up to Delivery | After week 27 of pregnancy | Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reporting Cases of Congenital Anomalies in the Neonates | From week 27 of pregnancy up to birth | Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Pregnancy-related AEs and Birth Outcomes Per Calendar Year | After week 27 of pregnancy | Analysis was performed on the Unexposed Cohort which included women pregnant before implementation of the maternal immunization program, who didn't receive Refortrix, the study vaccine. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Reporting Gestational Diabetes | Exposed Cohort | 10 | Participants | ||
| Number of Subjects Reporting Gestational Diabetes | Unexposed Cohort | 22 | Participants | ||
| Number of Subjects Reporting Pregnancy-related Hypertension, Pre-eclampsia, Eclampsia, and HELLP Syndrome | Exposed Cohort | Pregnancy-related hypertension | 11 | Participants | |
| Number of Subjects Reporting Pregnancy-related Hypertension, Pre-eclampsia, Eclampsia, and HELLP Syndrome | Unexposed Cohort | Pregnancy-related hypertension | 31 | Participants | |
| Number of Subjects Reporting Pregnancy-related Hypertension, Pre-eclampsia, Eclampsia, and HELLP Syndrome | Exposed Cohort | Pre-eclampsia | 10 | Participants | |
| Number of Subjects Reporting Pregnancy-related Hypertension, Pre-eclampsia, Eclampsia, and HELLP Syndrome | Unexposed Cohort | Pre-eclampsia | 30 | Participants | |
| Number of Subjects Reporting Pregnancy-related Hypertension, Pre-eclampsia, Eclampsia, and HELLP Syndrome | Exposed Cohort | Eclampsia | 2 | Participants | |
| Number of Subjects Reporting Pregnancy-related Hypertension, Pre-eclampsia, Eclampsia, and HELLP Syndrome | Unexposed Cohort | Eclampsia | 0 | Participants | |
| Number of Subjects Reporting Pregnancy-related Hypertension, Pre-eclampsia, Eclampsia, and HELLP Syndrome | Exposed Cohort | HELLP syndrome | 0 | Participants | |
| Number of Subjects Reporting Pregnancy-related Hypertension, Pre-eclampsia, Eclampsia, and HELLP Syndrome | Unexposed Cohort | HELLP syndrome | 1 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Exposed Cohort | 1,203 | |
| Overall Study | STARTED | Unexposed Cohort | 1,259 | |
| Overall Study | COMPLETED | Exposed Cohort | 1,199 | |
| Overall Study | COMPLETED | Unexposed Cohort | 1,248 | |
| Overall Study | NOT COMPLETED | Exposed Cohort | 4 | |
| Overall Study | NOT COMPLETED | Unexposed Cohort | 11 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Unexposed Cohort | 0 | 0 |
| Total, all-cause mortality | Exposed Cohort | 0 | 0 |
| Total, other adverse events | Unexposed Cohort | 0 | 0 |
| Total, other adverse events | Exposed Cohort | 0 | 0 |
| Total, serious adverse events | Unexposed Cohort | 0 | 0 |
| Total, serious adverse events | Exposed Cohort | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31216218 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Exposed Cohort vs Unexposed Cohort: Number of Subjects With Pre-specified Neonate-related Outcomes, Resulting in Neonates Small for Their Gestational Age | Trial comparisons |
| Exposed Cohort vs Unexposed Cohort: Number of Subjects Reporting Gestational Diabetes | Trial comparisons |
| Exposed Cohort vs Unexposed Cohort: Number of Subjects With Pre-specified Neonate-related Outcomes Resulting in Preterm Birth | Trial comparisons |
| Exposed Cohort vs Unexposed Cohort: Number of Subjects Reporting Pregnancy Hemorrhage | Trial comparisons |
| Exposed Cohort vs Unexposed Cohort: Number of Subjects Reporting Cases of Congenital Anomalies in the Neonates | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02757950
GET https://conductscience.org/api/trials/v1/NCT02757950/results?page=2