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

Novartis Vaccines3,243 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

3,243

Conditions

Pregnancy, Newborn Health

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (10)

Centro Sanitario de Santo Domingo

Santo Domingo, Dominican Republic

Maternidad Nuestra Senora de La Altagracia

Santo Domingo, Dominican Republic

CISM Manhica Health Research Centre

Manhiça, Mozambique

Policentro Juan Diaz

Panama City, Panama

Policentro Parque Lefevre

Panama City, Panama

Policlínica JJ Vallarino

Panama City, Panama

Children's Infectious Diseases Clinical Research Unit

Cape Town, South Africa

Setshaba Research Centre

Gauteng, South Africa

Synexus Research Centre

Gauteng, South Africa

Respiratory and Meningeal Pathogens Research Unit

Soweto, Johannesburg, South Africa

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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)

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)