Pregnancy, Newborn Health Clinical Trial
Official title:
A Multicenter, Observational Study to Identify Factors That Influence Access of Pregnant Women and Their Infants to Their Local Healthcare Systems
| NCT number | NCT01734434 |
| Other study ID # | V98_15OB |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 2012 |
| Est. completion date | January 2015 |
| Verified date | July 2017 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 3243 |
| Est. completion date | January 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
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: |
| Country | Name | City | State |
|---|---|---|---|
| Dominican Republic | Centro Sanitario de Santo Domingo | Santo Domingo | |
| Dominican Republic | Maternidad Nuestra Senora de La Altagracia | Santo Domingo | |
| Mozambique | CISM Manhica Health Research Centre | Manhiça | |
| Panama | Policentro Juan Diaz | Panama City | |
| Panama | Policentro Parque Lefevre | Panama City | |
| Panama | Policlínica JJ Vallarino | Panama City | |
| South Africa | Children's Infectious Diseases Clinical Research Unit | Cape Town | |
| South Africa | Setshaba Research Centre | Gauteng | |
| South Africa | Synexus Research Centre | Gauteng | |
| South Africa | Respiratory and Meningeal Pathogens Research Unit | Soweto, Johannesburg |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Vaccines | GlaxoSmithKline |
Dominican Republic, Mozambique, Panama, South Africa,
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. — View Citation
WHO. Antenatal care in developing countries. Promises, achievements and missed opportunities. An analysis of trends, levels and differentials, 1990-2001. Geneva: 2003.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Secondary | Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site. | The number of infants born live, reported sick and brought to a study or non-study health care facility site by the maternal subjects over the period of 90 days after delivery was calculated. | Delivery to Day 90 post-delivery (Infant follow-up) | |
| Secondary | Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery) | The number of infants who were brought by the maternal subjects to a study site for 90-day infant follow-up visit relative to the number of live birth deliveries. | Delivery to Day 90 post-delivery (Infant follow-up) |