Study to Identify Factors Influencing Access of Pregnant Women and Their Infants to Local Healthcare Systems

Study Overview
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Brief Summary
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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: 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

Official Title
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A Multicenter, Observational Study to Identify Factors That Influence Access of Pregnant Women and Their Infants to Their Local Healthcare Systems

Conditions
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Pregnancy, Newborn Health

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br>24 weeks or more of gestation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health care access, Pregnant women