MedDataX Logo

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

NCT ID: NCT01734434

Last Updated: 2018-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3243 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy, Newborn Health

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Health care access, Pregnant women

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pregnant women

24 weeks or more of gestation

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Vaccines and Diagnostics

Role: STUDY_CHAIR

Novartis Vaccines

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centro Sanitario de Santo Domingo

Santo Domingo, , Dominican Republic

Site Status

Maternidad Nuestra Senora de La Altagracia

Santo Domingo, , Dominican Republic

Site Status

CISM Manhica Health Research Centre

Manhiça, , Mozambique

Site Status

Policentro Juan Diaz

Panama City, , Panama

Site Status

Policentro Parque Lefevre

Panama City, , Panama

Site Status

Policlínica JJ Vallarino

Panama City, , Panama

Site Status

Children's Infectious Diseases Clinical Research Unit

Cape Town, , South Africa

Site Status

Setshaba Research Centre

Gauteng, , South Africa

Site Status

Synexus Research Centre

Gauteng, , South Africa

Site Status

Respiratory and Meningeal Pathogens Research Unit

Soweto, Johannesburg, , South Africa

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Dominican Republic Mozambique Panama South Africa

References

Explore related publications, articles, or registry entries linked to this study.

WHO. Antenatal care in developing countries. Promises, achievements and missed opportunities. An analysis of trends, levels and differentials, 1990-2001. Geneva: 2003.

Reference Type BACKGROUND

Assembly UNG. A world fit for children. Outcome document of the Special Session on Children. New York: 2002.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 19106756 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29334920 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

V98_15OB

Identifier Type: -

Identifier Source: org_study_id