Clinical trial NCT01734434: Study to Identify Factors Influencing Access of Pregnant Women and Their Infants to Local Healthcare Systems
Official title: A Multicenter, Observational Study to Identify Factors That Influence Access of Pregnant Women and Their Infants to Their Local Healthcare Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy, Newborn Health
Keywords: Health care access, Pregnant women
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2012-11-27
Enrollment: 3243
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women of gestational age 24 weeks or more

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Percentage of Subjects Delivering at a Study Site.
timeFrame: Baseline until average of 24 weeks
measure: Percentage of Subjects Delivering at a Non-study Site.
timeFrame: Baseline until average of 24 weeks
Secondary outcomes:
measure: Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site.
timeFrame: Delivery to Day 90 post-delivery (Infant follow-up)
measure: Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery)
timeFrame: Delivery to Day 90 post-delivery (Infant follow-up)
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Centro Sanitario de Santo Domingo
city: Santo Domingo
country: Dominican Republic
facility: Maternidad Nuestra Senora de La Altagracia
city: Manhiça
country: Mozambique
facility: CISM Manhica Health Research Centre
city: Panama City
country: Panama
facility: Policentro Juan Diaz
city: Panama City
country: Panama
facility: Policentro Parque Lefevre
city: Panama City
country: Panama
facility: Policlínica JJ Vallarino
city: Cape Town
country: South Africa
facility: Children's Infectious Diseases Clinical Research Unit
city: Gauteng
country: South Africa
facility: Setshaba Research Centre
city: Gauteng
country: South Africa
facility: Synexus Research Centre
city: Soweto, Johannesburg
country: South Africa
facility: Respiratory and Meningeal Pathogens Research Unit
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines and Diagnostics
role: STUDY_CHAIR
References:
citation: WHO. Antenatal care in developing countries. Promises, achievements and missed opportunities. An analysis of trends, levels and differentials, 1990-2001. Geneva: 2003.
citation: Assembly UNG. A world fit for children. Outcome document of the Special Session on Children. New York: 2002.
citation: 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.
citation: 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.