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

Novartis

Status: Completed

Conditions: Pregnancy, Newborn Health

Study type: Observational

Funder types: Industry

Identifiers

NCT01734434

V98_15OB

Details and patient eligibility

About

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

Enrollment: 3,243 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

3,243 participants in 1 patient group

Pregnant women

Description:

24 weeks or more of gestation