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

Completed
Conditions
Pregnancy, Newborn Health
Registration Number
NCT01734434
Lead Sponsor
Novartis Vaccines
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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
3243
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.

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

Secondary Outcome Measures
NameTimeMethod
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.

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.

Trial Locations

Locations (10)

Centro Sanitario de Santo Domingo

🇩🇴

Santo Domingo, Dominican Republic

CISM Manhica Health Research Centre

🇲🇿

Manhiça, Mozambique

Synexus Research Centre

🇿🇦

Gauteng, South Africa

Children's Infectious Diseases Clinical Research Unit

🇿🇦

Cape Town, South Africa

Policentro Juan Diaz

🇵🇦

Panama City, Panama

Maternidad Nuestra Senora de La Altagracia

🇩🇴

Santo Domingo, Dominican Republic

Policlínica JJ Vallarino

🇵🇦

Panama City, Panama

Setshaba Research Centre

🇿🇦

Gauteng, South Africa

Policentro Parque Lefevre

🇵🇦

Panama City, Panama

Respiratory and Meningeal Pathogens Research Unit

🇿🇦

Soweto, Johannesburg, South Africa

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