N/A
N=3,243
Study to Identify Factors Influencing Access of Pregnant Women and Their Infants to Local Healthcare Systems
Pregnancy, Newborn Health
Bottom Line
View on ClinicalTrials.gov: NCT01734434 ↗Enrolled (actual)
3,243
Serious AEs
—
Results posted
Dec 2018
Primary outcome: Primary: Percentage of Subjects Delivering at a Study Site. — 99.20; 100; 99.65; 100 Percentages of subjects
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Novartis Vaccines
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Delivering at a Study Site. |
99.20; 100; 99.65; 100; 68.55; 74.40 | — |
| PRIMARY Percentage of Subjects Delivering at a Non-study Site. |
99.20; 100; 99.65; 100; 30.85; 24.60 | — |
| SECONDARY Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site. |
493; 498; 1966; 242; 58; 81 | — |
| SECONDARY Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery) |
479; 333; 1163; 146 | — |
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
Eligibility Criteria
Inclusion Criteria
- Pregnant women with gestational age of greater than or equal to 24 weeks at the time of enrollment
- 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
- Pregnant women of gestational age between 28 weeks and 34 weeks 6/7 days
Exclusion Criteria
None
Data sourced from ClinicalTrials.gov (NCT01734434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.