A Multicenter, Observational Study to Identify Factors That Influence Access of Pregnant Women and Their Infants to Their Local Healthcare Systems
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 3,243
- Locations
- 10
- Primary Endpoint
- Percentage of Subjects Delivering at a Non-study Site.
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Ecologic Or Community
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
Percentage of Subjects Delivering at a Non-study Site.
Time Frame: 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.
Percentage of Subjects Delivering at a Study Site.
Time Frame: 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
Secondary Outcomes
- Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery)(Delivery to Day 90 post-delivery (Infant follow-up))
- 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))