Pregnancy, Newborn Health
Conditions
Keywords
Health care access, Pregnant women
Brief summary
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: * Logistics of transportation to the study site (type, time it takes, cost incurred) * Accessibility to a telephone/cell phone * Provisions of alternative child care during site visits if there are other children under the subject's care
Interventions
None listed
Sponsors
GlaxoSmithKline
Novartis Vaccines
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
1. Pregnant women with gestational age of greater than or equal to 24 weeks at the time of enrollment 2. Subject / subject's parents or a legal representative who has given written consent after the nature of the study has been explained according to local regulatory requirements 3. Pregnant women of gestational age between 28 weeks and 34 weeks 6/7 days
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Delivering at a Study Site. | Baseline until average of 24 weeks | The percentage of subjects who delivered at the study site relative to the number of enrolled subjects was calculated |
| Percentage of Subjects Delivering at a Non-study Site. | Baseline until average of 24 weeks | The percentage of subjects who delivered at a non-study site relative to the number of enrolled subjects was calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site. | Delivery to Day 90 post-delivery (Infant follow-up) | 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. |
| Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery) | Delivery to Day 90 post-delivery (Infant follow-up) | 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. |
Countries
Dominican Republic, Mozambique, Panama, South Africa
Participant flow
Recruitment details
Subjects were enrolled at Dominican Republic, Panama, Mozambique, and South Africa.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Maternal Subjects (Dominican Republic) Pregnant women who were enrolled in Dominican Republic. | 500 |
| Maternal Subjects (Panama) Pregnant women who were enrolled in Panama. | 500 |
| Maternal Subjects (South Africa) Pregnant women who were enrolled in South Africa. | 1,989 |
| Maternal Subjects (Mozambique) Pregnant women who were enrolled in Mozambique. | 251 |
| Total | 3,240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | 17 Yr Old Subject Signed Consent form | 0 | 0 | 1 | 0 |
| Overall Study | Death Infant | 3 | 1 | 17 | 5 |
| Overall Study | Lost to Follow-up | 2 | 9 | 67 | 11 |
| Overall Study | No Live Birth | 1 | 2 | 32 | 6 |
| Overall Study | Signed Adult Version of Consent Form | 0 | 0 | 1 | 0 |
| Overall Study | Subject Not Reachable | 0 | 0 | 1 | 0 |
| Overall Study | Treatment Defaulter | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 8 | 1 |
| Overall Study | Wrong Version of Consent Form Signed | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Maternal Subjects (Dominican Republic) | Maternal Subjects (Panama) | Maternal Subjects (South Africa) | Maternal Subjects (Mozambique) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 24.49 Years STANDARD_DEVIATION 5.28 | 25.08 Years STANDARD_DEVIATION 5.65 | 27.05 Years STANDARD_DEVIATION 6.05 | 25.01 Years STANDARD_DEVIATION 6.26 | 26.19 Years STANDARD_DEVIATION 5.99 |
| Sex: Female, Male Female | 500 Participants | 500 Participants | 1989 Participants | 251 Participants | 3240 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Baseline until average of 24 weeks
Population: Analysis was done on FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maternal Subjects (Dominican Republic) | Percentage of Subjects Delivering at a Non-study Site. | Other | 0 Percentages of subjects |
| Maternal Subjects (Dominican Republic) | Percentage of Subjects Delivering at a Non-study Site. | Non-study healthcare facility | 30.85 Percentages of subjects |
| Maternal Subjects (Dominican Republic) | Percentage of Subjects Delivering at a Non-study Site. | Unknown | 0.60 Percentages of subjects |
| Maternal Subjects (Dominican Republic) | Percentage of Subjects Delivering at a Non-study Site. | Home | 0 Percentages of subjects |
| Maternal Subjects (Dominican Republic) | Percentage of Subjects Delivering at a Non-study Site. | Subjects with known delivery information | 99.20 Percentages of subjects |
| Maternal Subjects (Panama) | Percentage of Subjects Delivering at a Non-study Site. | Home | 0.40 Percentages of subjects |
| Maternal Subjects (Panama) | Percentage of Subjects Delivering at a Non-study Site. | Other | 0 Percentages of subjects |
| Maternal Subjects (Panama) | Percentage of Subjects Delivering at a Non-study Site. | Unknown | 0.60 Percentages of subjects |
| Maternal Subjects (Panama) | Percentage of Subjects Delivering at a Non-study Site. | Non-study healthcare facility | 24.60 Percentages of subjects |
| Maternal Subjects (Panama) | Percentage of Subjects Delivering at a Non-study Site. | Subjects with known delivery information | 100 Percentages of subjects |
| Maternal Subjects (South Africa) | Percentage of Subjects Delivering at a Non-study Site. | Home | 0.76 Percentages of subjects |
| Maternal Subjects (South Africa) | Percentage of Subjects Delivering at a Non-study Site. | Subjects with known delivery information | 99.65 Percentages of subjects |
| Maternal Subjects (South Africa) | Percentage of Subjects Delivering at a Non-study Site. | Non-study healthcare facility | 41.32 Percentages of subjects |
| Maternal Subjects (South Africa) | Percentage of Subjects Delivering at a Non-study Site. | Other | 0.50 Percentages of subjects |
| Maternal Subjects (South Africa) | Percentage of Subjects Delivering at a Non-study Site. | Unknown | 0.76 Percentages of subjects |
| Maternal Subjects (Mozambique) | Percentage of Subjects Delivering at a Non-study Site. | Other | 0.40 Percentages of subjects |
| Maternal Subjects (Mozambique) | Percentage of Subjects Delivering at a Non-study Site. | Non-study healthcare facility | 7.97 Percentages of subjects |
| Maternal Subjects (Mozambique) | Percentage of Subjects Delivering at a Non-study Site. | Subjects with known delivery information | 100 Percentages of subjects |
| Maternal Subjects (Mozambique) | Percentage of Subjects Delivering at a Non-study Site. | Home | 2.79 Percentages of subjects |
| Maternal Subjects (Mozambique) | Percentage of Subjects Delivering at a Non-study Site. | Unknown | 1.99 Percentages of subjects |
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
Time frame: Baseline until average of 24 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maternal Subjects (Dominican Republic) | Percentage of Subjects Delivering at a Study Site. | Subjects with known delivery information | 99.20 Percentages of subjects |
| Maternal Subjects (Dominican Republic) | Percentage of Subjects Delivering at a Study Site. | Study site delivery | 68.55 Percentages of subjects |
| Maternal Subjects (Panama) | Percentage of Subjects Delivering at a Study Site. | Study site delivery | 74.40 Percentages of subjects |
| Maternal Subjects (Panama) | Percentage of Subjects Delivering at a Study Site. | Subjects with known delivery information | 100 Percentages of subjects |
| Maternal Subjects (South Africa) | Percentage of Subjects Delivering at a Study Site. | Subjects with known delivery information | 99.65 Percentages of subjects |
| Maternal Subjects (South Africa) | Percentage of Subjects Delivering at a Study Site. | Study site delivery | 56.66 Percentages of subjects |
| Maternal Subjects (Mozambique) | Percentage of Subjects Delivering at a Study Site. | Subjects with known delivery information | 100 Percentages of subjects |
| Maternal Subjects (Mozambique) | Percentage of Subjects Delivering at a Study Site. | Study site delivery | 86.85 Percentages of subjects |
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.
Time frame: Delivery to Day 90 post-delivery (Infant follow-up)
Population: Analysis was done on the FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maternal Subjects (Dominican Republic) | Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site. | Infants reported sick | 58 participants |
| Maternal Subjects (Dominican Republic) | Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site. | Live births at discharge | 493 participants |
| Maternal Subjects (Dominican Republic) | Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site. | Infants brought to health care facility-study site | 54 participants |
| Maternal Subjects (Panama) | Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site. | Infants reported sick | 81 participants |
| Maternal Subjects (Panama) | Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site. | Infants brought to health care facility-study site | 147 participants |
| Maternal Subjects (Panama) | Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site. | Live births at discharge | 498 participants |
| Maternal Subjects (South Africa) | Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site. | Infants reported sick | 74 participants |
| Maternal Subjects (South Africa) | Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site. | Infants brought to health care facility-study site | 27 participants |
| Maternal Subjects (South Africa) | Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site. | Live births at discharge | 1966 participants |
| Maternal Subjects (Mozambique) | Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site. | Infants brought to health care facility-study site | 51 participants |
| Maternal Subjects (Mozambique) | Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site. | Live births at discharge | 242 participants |
| Maternal Subjects (Mozambique) | Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site. | Infants reported sick | 5 participants |
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.
Time frame: Delivery to Day 90 post-delivery (Infant follow-up)
Population: Analysis was performed on the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maternal Subjects (Dominican Republic) | Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery) | 479 participants |
| Maternal Subjects (Panama) | Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery) | 333 participants |
| Maternal Subjects (South Africa) | Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery) | 1163 participants |
| Maternal Subjects (Mozambique) | Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery) | 146 participants |