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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01734434
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : February 25, 2015
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Brief Summary:

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 or disease
Pregnancy, Newborn Health

Study Type : Observational
Actual Enrollment : 3257 participants
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
Study Start Date : November 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Pregnant women
24 weeks or more of gestation

Primary Outcome Measures :
  1. Identify factors that might influence if a pregnant woman [ Time Frame: 24 weeks or more of gestation ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pregnant women of gestational age 24 weeks or more

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01734434

Dominican Republic
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
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
Study Chair: Novartis Vaccines and Diagnostics Novartis Vaccines

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.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Vaccines Identifier: NCT01734434     History of Changes
Other Study ID Numbers: V98_15OB
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: February 25, 2015
Last Verified: February 2015

Keywords provided by Novartis ( Novartis Vaccines ):
Health care access, Pregnant women