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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This study collected information regarding the factors that might influence access of pregnant women to the local healthcare system. The main visits of the study screened & enrollment, delivery and 90 day infant follow-up. Data were collected mainly from questionnaires administered to pregnant women at these visits. The questionnaires contained the following standard questions which were asked at each visit, in addition to some visit-specific questions related to delivery and health status of infants up to 90 days of age. The standard questions related to the following aspects:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women | 24 weeks or more of gestation |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Delivering at a Study Site. | The percentage of subjects who delivered at the study site relative to the number of enrolled subjects was calculated | Baseline until average of 24 weeks |
| Percentage of Subjects Delivering at a Non-study Site. | The percentage of subjects who delivered at a non-study site relative to the number of enrolled subjects was calculated. | Baseline until average of 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site. | The number of infants born live, reported sick and brought to a study or non-study health care facility site by the maternal subjects over the period of 90 days after delivery was calculated. | Delivery to Day 90 post-delivery (Infant follow-up) |
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Inclusion Criteria:
Exclusion Criteria:
None
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Pregnant women of gestational age 24 weeks or more
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines and Diagnostics | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Sanitario de Santo Domingo | Santo Domingo | Dominican Republic | ||||
| Maternidad Nuestra Senora de La Altagracia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | WHO. Antenatal care in developing countries. Promises, achievements and missed opportunities. An analysis of trends, levels and differentials, 1990-2001. Geneva: 2003. | ||
| Background | Assembly UNG. A world fit for children. Outcome document of the Special Session on Children. New York: 2002. | ||
| 19106756 | Background | Qazi SA, Stoll BJ. Neonatal sepsis: a major global public health challenge. Pediatr Infect Dis J. 2009 Jan;28(1 Suppl):S1-2. doi: 10.1097/INF.0b013e31819587a9. No abstract available. | |
| 29334920 |
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All enrolled subjects were included in the trial.
Subjects were enrolled at Dominican Republic, Panama, Mozambique, and South Africa.
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| ID | Title | Description |
|---|---|---|
| FG000 | Maternal Subjects (Dominican Republic) | Pregnant women who were enrolled in Dominican Republic. |
| FG001 | Maternal Subjects (Panama) | Pregnant women who were enrolled in Panama. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery) | The number of infants who were brought by the maternal subjects to a study site for 90-day infant follow-up visit relative to the number of live birth deliveries. | Delivery to Day 90 post-delivery (Infant follow-up) |
| Santo Domingo |
| Dominican Republic |
| CISM Manhica Health Research Centre | Manhiça | Mozambique |
| Policentro Juan Diaz | Panama City | Panama |
| Policentro Parque Lefevre | Panama City | Panama |
| PoliclÃnica JJ Vallarino | Panama City | Panama |
| Children's Infectious Diseases Clinical Research Unit | Cape Town | 7500 | South Africa |
| Setshaba Research Centre | Gauteng | 0152 | South Africa |
| Synexus Research Centre | Gauteng | South Africa |
| Respiratory and Meningeal Pathogens Research Unit | Soweto, Johannesburg | South Africa |
| Derived |
| Madhi SA, Rivera LM, Saez-Llorens X, Menendez C, Carrim-Ganey N, Cotton MF, Katzman D, Luttig MM, Candelario R, Baker S, Roychoudhury M. Factors influencing access of pregnant women and their infants to their local healthcare system: a prospective, multi-centre, observational study. BMC Pregnancy Childbirth. 2018 Jan 15;18(1):29. doi: 10.1186/s12884-017-1655-3. |
| FG002 | Maternal Subjects (South Africa) | Pregnant women who were enrolled in South Africa. |
| FG003 | Maternal Subjects (Mozambique) | Pregnant women who were enrolled in Mozambique. |
| COMPLETED |
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| NOT COMPLETED |
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Demographic data was analysed on Full analysis set (FAS) population-All subjects in the all enrolled set who provided data after enrollment related to delivery, logistics or medical outcomes.
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| ID | Title | Description |
|---|---|---|
| BG000 | Maternal Subjects (Dominican Republic) | Pregnant women who were enrolled in Dominican Republic. |
| BG001 | Maternal Subjects (Panama) | Pregnant women who were enrolled in Panama. |
| BG002 | Maternal Subjects (South Africa) | Pregnant women who were enrolled in South Africa. |
| BG003 | Maternal Subjects (Mozambique) | Pregnant women who were enrolled in Mozambique. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Percentage of Subjects Delivering at a Study Site. | The percentage of subjects who delivered at the study site relative to the number of enrolled subjects was calculated | Analysis was done on Full analysis set (FAS)-All subjects in the All Enrolled Set who provided data after enrollment related to delivery, logistics or medical outcomes. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Baseline until average of 24 weeks |
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| Primary | Percentage of Subjects Delivering at a Non-study Site. | The percentage of subjects who delivered at a non-study site relative to the number of enrolled subjects was calculated. | Analysis was done on FAS. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Baseline until average of 24 weeks |
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| Secondary | Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site. | The number of infants born live, reported sick and brought to a study or non-study health care facility site by the maternal subjects over the period of 90 days after delivery was calculated. | Analysis was done on the FAS | Posted | Number | participants | Delivery to Day 90 post-delivery (Infant follow-up) |
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| Secondary | Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery) | The number of infants who were brought by the maternal subjects to a study site for 90-day infant follow-up visit relative to the number of live birth deliveries. | Analysis was performed on the FAS. | Posted | Number | participants | Delivery to Day 90 post-delivery (Infant follow-up) |
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Adverse event data were not collected.
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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 | Maternal Subjects (Dominican Republic) | Pregnant women who were enrolled in Dominican Republic. | 0 | 0 | 0 | 0 | ||
| EG001 | Maternal Subjects (Panama) | Pregnant women who were enrolled in Panama. | 0 | 0 | 0 | 0 | ||
| EG002 | Maternal Subjects (South Africa) | Pregnant women who were enrolled in South Africa. | 0 | 0 | 0 | 0 | ||
| EG003 | Maternal Subjects (Mozambique) | Pregnant women who were enrolled in Mozambique. | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
| Male |
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| Study site delivery |
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