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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01734434
First received: November 22, 2012
Last updated: February 24, 2015
Last verified: February 2015
  Purpose

This study will collect information regarding the factors that might influence access of pregnant women to the local healthcare system. The main visits of the study will be screening & enrollment, delivery and 90 day infant follow-up. Data will be collected mainly from questionnaires administered to pregnant women at these visits. The questionnaires contain the following standard questions which will be 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 will be 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

Condition
Pregnancy, Newborn Health

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: A Multicenter, Observational Study to Identify Factors That Influence Access of Pregnant Women and Their Infants to Their Local Healthcare Systems

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Identify factors that might influence if a pregnant woman [ Time Frame: 24 weeks or more of gestation ] [ Designated as safety issue: No ]

    Identify factors that might influence if a pregnant woman:

    • will enroll in this study
    • will return to a study site to deliver
    • will seek medical attention for her sick infant at a study site
    • will bring her infant back to a study site for a follow-up visit at 90 days of age


Enrollment: 3257
Study Start Date: November 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant women
24 weeks or more of gestation

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Pregnant women of gestational age 24 weeks or more

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734434

Locations
Dominican Republic
Centro Sanitario de Santo Domingo
Santo Domingo, Dominican Republic
Maternidad Nuestra Senora de La Altagracia
Santo Domingo, Dominican Republic
Mozambique
CISM Manhica Health Research Centre
Manhiça, Mozambique
Panama
Policentro Juan Diaz
Panama City, Panama
Policentro Parque Lefevre
Panama City, Panama
Policlínica JJ Vallarino
Panama City, Panama
South Africa
Children's Infectious Diseases Clinical Research Unit
Cape Town, South Africa, 7500
Setshaba Research Centre
Gauteng, South Africa, 0152
Synexus Research Centre
Gauteng, South Africa
Respiratory and Meningeal Pathogens Research Unit
Soweto, Johannesburg, South Africa
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines and Diagnostics Novartis Vaccines
  More Information

Publications:
WHO. Antenatal care in developing countries. Promises, achievements and missed opportunities. An analysis of trends, levels and differentials, 1990-2001. Geneva: 2003.
Assembly UNG. A world fit for children. Outcome document of the Special Session on Children. New York: 2002.

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01734434     History of Changes
Other Study ID Numbers: V98_15OB
Study First Received: November 22, 2012
Last Updated: February 24, 2015
Health Authority: Dominican Republic: Consejo Nacional de Bioetica en Salud

Keywords provided by Novartis:
Health care access, Pregnant women

ClinicalTrials.gov processed this record on August 31, 2015