Sponsor study identifier
observational
3,243
4 countries
10
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
November 22, 2012
Actual (reported)November 27, 2012
Actual (reported)January 2015
Actual (reported)January 2015
Actual (reported)December 11, 2018
Actual (reported)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
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.
Baseline until average of 24 weeks
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)
Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery)
Delivery to Day 90 post-delivery (Infant follow-up)
24 weeks or more of gestation
Pregnant women of gestational age 24 weeks or more
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, 7500, South Africa
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.
Qazi SA, Stoll BJ. Neonatal sepsis: a major global public health challenge. Pediatr Infect Dis J. 2009 Jan;28(1 Suppl):S1-2. doi: 10.1097/INF.0b013e31819587a9. No abstract available.
Novartis Vaccines and Diagnostics
Novartis Vaccines
3,243 participants (actual enrollment reported by the registry).
First Submitted
November 22, 2012
First Posted
November 27, 2012
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Setshaba Research Centre
Gauteng, 0152, South Africa
Synexus Research Centre
Gauteng, South Africa
Respiratory and Meningeal Pathogens Research Unit
Soweto, Johannesburg, South Africa
Madhi SA, Rivera LM, Saez-Llorens X, Menendez C, Carrim-Ganey N, Cotton MF, Katzman D, Luttig MM, Candelario R, Baker S, Roychoudhury M. Factors influencing access of pregnant women and their infants to their local healthcare system: a prospective, multi-centre, observational study. BMC Pregnancy Childbirth. 2018 Jan 15;18(1):29. doi: 10.1186/s12884-017-1655-3.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)Last Updated
December 11, 2018
Results First Posted
December 11, 2018
Record last verified: 2017-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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