Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-01-26 @ 10:32 PM
Study NCT ID:
NCT01734434
Status:
COMPLETED
Last Update Posted:
2018-12-11
First Post:
2012-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Identify Factors Influencing Access of Pregnant Women and Their Infants to Local Healthcare Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Adverse event data were not collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Maternal Subjects (Dominican Republic)', 'description': 'Pregnant women who were enrolled in Dominican Republic.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Maternal Subjects (Panama)', 'description': 'Pregnant women who were enrolled in Panama.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Maternal Subjects (South Africa)', 'description': 'Pregnant women who were enrolled in South Africa.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Maternal Subjects (Mozambique)', 'description': 'Pregnant women who were enrolled in Mozambique.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Delivering at a Study Site.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}, {'value': '1989', 'groupId': 'OG002'}, {'value': '251', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Subjects (Dominican Republic)', 'description': 'Pregnant women who were enrolled in Dominican Republic.'}, {'id': 'OG001', 'title': 'Maternal Subjects (Panama)', 'description': 'Pregnant women who were enrolled in Panama.'}, {'id': 'OG002', 'title': 'Maternal Subjects (South Africa)', 'description': 'Pregnant women who were enrolled in South Africa.'}, {'id': 'OG003', 'title': 'Maternal Subjects (Mozambique)', 'description': 'Pregnant women who were enrolled in Mozambique.'}], 'classes': [{'title': 'Subjects with known delivery information', 'categories': [{'measurements': [{'value': '99.20', 'groupId': 'OG000', 'lowerLimit': '97.96', 'upperLimit': '99.78'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '99.26', 'upperLimit': '100'}, {'value': '99.65', 'groupId': 'OG002', 'lowerLimit': '99.28', 'upperLimit': '99.86'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '98.54', 'upperLimit': '100'}]}]}, {'title': 'Study site delivery', 'categories': [{'measurements': [{'value': '68.55', 'groupId': 'OG000', 'lowerLimit': '64.26', 'upperLimit': '72.61'}, {'value': '74.40', 'groupId': 'OG001', 'lowerLimit': '70.34', 'upperLimit': '78.17'}, {'value': '56.66', 'groupId': 'OG002', 'lowerLimit': '54.44', 'upperLimit': '58.86'}, {'value': '86.85', 'groupId': 'OG003', 'lowerLimit': '82.03', 'upperLimit': '90.77'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until average of 24 weeks', 'description': 'The percentage of subjects who delivered at the study site relative to the number of enrolled subjects was calculated', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on Full analysis set (FAS)-All subjects in the All Enrolled Set who provided data after enrollment related to delivery, logistics or medical outcomes.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Delivering at a Non-study Site.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}, {'value': '1989', 'groupId': 'OG002'}, {'value': '251', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Subjects (Dominican Republic)', 'description': 'Pregnant women who were enrolled in Dominican Republic.'}, {'id': 'OG001', 'title': 'Maternal Subjects (Panama)', 'description': 'Pregnant women who were enrolled in Panama.'}, {'id': 'OG002', 'title': 'Maternal Subjects (South Africa)', 'description': 'Pregnant women who were enrolled in South Africa.'}, {'id': 'OG003', 'title': 'Maternal Subjects (Mozambique)', 'description': 'Pregnant women who were enrolled in Mozambique.'}], 'classes': [{'title': 'Subjects with known delivery information', 'categories': [{'measurements': [{'value': '99.20', 'groupId': 'OG000', 'lowerLimit': '97.96', 'upperLimit': '99.78'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '99.26', 'upperLimit': '100'}, {'value': '99.65', 'groupId': 'OG002', 'lowerLimit': '99.28', 'upperLimit': '99.86'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '98.54', 'upperLimit': '100'}]}]}, {'title': 'Non-study healthcare facility', 'categories': [{'measurements': [{'value': '30.85', 'groupId': 'OG000', 'lowerLimit': '26.81', 'upperLimit': '35.12'}, {'value': '24.60', 'groupId': 'OG001', 'lowerLimit': '20.88', 'upperLimit': '28.62'}, {'value': '41.32', 'groupId': 'OG002', 'lowerLimit': '39.14', 'upperLimit': '43.53'}, {'value': '7.97', 'groupId': 'OG003', 'lowerLimit': '4.93', 'upperLimit': '12.04'}]}]}, {'title': 'Home', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0.40', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '1.44'}, {'value': '0.76', 'groupId': 'OG002', 'lowerLimit': '0.42', 'upperLimit': '1.25'}, {'value': '2.79', 'groupId': 'OG003', 'lowerLimit': '1.13', 'upperLimit': '5.66'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0.50', 'groupId': 'OG002', 'lowerLimit': '0.24', 'upperLimit': '0.93'}, {'value': '0.40', 'groupId': 'OG003', 'lowerLimit': '0.01', 'upperLimit': '2.20'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0.60', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '1.76'}, {'value': '0.60', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '1.74'}, {'value': '0.76', 'groupId': 'OG002', 'lowerLimit': '0.42', 'upperLimit': '1.25'}, {'value': '1.99', 'groupId': 'OG003', 'lowerLimit': '0.65', 'upperLimit': '4.59'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until average of 24 weeks', 'description': 'The percentage of subjects who delivered at a non-study site relative to the number of enrolled subjects was calculated.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS.'}, {'type': 'SECONDARY', 'title': 'Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}, {'value': '1966', 'groupId': 'OG002'}, {'value': '242', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Subjects(Dominican Republic)', 'description': 'pregnant women who were enrolled in Dominican Republic.'}, {'id': 'OG001', 'title': 'Maternal Subjects(Panama)', 'description': 'pregnant women who were enrolled in Panama.'}, {'id': 'OG002', 'title': 'Maternal Subjects (South Africa)', 'description': 'pregnant women who were enrolled in South Africa.'}, {'id': 'OG003', 'title': 'Maternal Subjects(Mozambique)', 'description': 'pregnant women who were enrolled in Mozambique.'}], 'classes': [{'title': 'Live births at discharge', 'categories': [{'measurements': [{'value': '493', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}, {'value': '1966', 'groupId': 'OG002'}, {'value': '242', 'groupId': 'OG003'}]}]}, {'title': 'Infants reported sick', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Infants brought to health care facility-study site', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Delivery to Day 90 post-delivery (Infant follow-up)', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the FAS'}, {'type': 'SECONDARY', 'title': 'Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}, {'value': '1966', 'groupId': 'OG002'}, {'value': '242', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Infants (Dominican Republic)', 'description': 'Infants born to pregnant women who were enrolled in Dominican Republic, brought to study site for 90-day follow up.'}, {'id': 'OG001', 'title': 'Infants (Panama)', 'description': 'Infants born to pregnant women who were enrolled in Panama, brought to study site for 90-day follow up.'}, {'id': 'OG002', 'title': 'Infants (South Africa)', 'description': 'Infants born to pregnant women who were enrolled in South Africa, brought to study site for 90-day follow up.'}, {'id': 'OG003', 'title': 'Infants (Mozambique)', 'description': 'Infants born to pregnant women who were enrolled in Mozambique, brought to study site for 90-day follow up.'}], 'classes': [{'categories': [{'measurements': [{'value': '479', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}, {'value': '1163', 'groupId': 'OG002'}, {'value': '146', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Delivery to Day 90 post-delivery (Infant follow-up)', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the FAS.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Maternal Subjects (Dominican Republic)', 'description': 'Pregnant women who were enrolled in Dominican Republic.'}, {'id': 'FG001', 'title': 'Maternal Subjects (Panama)', 'description': 'Pregnant women who were enrolled in Panama.'}, {'id': 'FG002', 'title': 'Maternal Subjects (South Africa)', 'description': 'Pregnant women who were enrolled in South Africa.'}, {'id': 'FG003', 'title': 'Maternal Subjects (Mozambique)', 'description': 'Pregnant women who were enrolled in Mozambique.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '500'}, {'groupId': 'FG001', 'numSubjects': '500'}, {'groupId': 'FG002', 'numSubjects': '1992'}, {'groupId': 'FG003', 'numSubjects': '251'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '490'}, {'groupId': 'FG001', 'numSubjects': '488'}, {'groupId': 'FG002', 'numSubjects': '1863'}, {'groupId': 'FG003', 'numSubjects': '228'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '129'}, {'groupId': 'FG003', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Death Infant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '67'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'No Live Birth', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Signed Adult Version of Consent Form', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject Not Reachable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Treatment Defaulter', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Wrong Version of Consent Form Signed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': '17 Yr Old Subject Signed Consent form', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were enrolled at Dominican Republic, Panama, Mozambique, and South Africa.', 'preAssignmentDetails': 'All enrolled subjects were included in the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1989', 'groupId': 'BG002'}, {'value': '251', 'groupId': 'BG003'}, {'value': '3240', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Maternal Subjects (Dominican Republic)', 'description': 'Pregnant women who were enrolled in Dominican Republic.'}, {'id': 'BG001', 'title': 'Maternal Subjects (Panama)', 'description': 'Pregnant women who were enrolled in Panama.'}, {'id': 'BG002', 'title': 'Maternal Subjects (South Africa)', 'description': 'Pregnant women who were enrolled in South Africa.'}, {'id': 'BG003', 'title': 'Maternal Subjects (Mozambique)', 'description': 'Pregnant women who were enrolled in Mozambique.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.49', 'spread': '5.28', 'groupId': 'BG000'}, {'value': '25.08', 'spread': '5.65', 'groupId': 'BG001'}, {'value': '27.05', 'spread': '6.05', 'groupId': 'BG002'}, {'value': '25.01', 'spread': '6.26', 'groupId': 'BG003'}, {'value': '26.19', 'spread': '5.99', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '500', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1989', 'groupId': 'BG002'}, {'value': '251', 'groupId': 'BG003'}, {'value': '3240', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Demographic data was analysed on Full analysis set (FAS) population-All subjects in the all enrolled set who provided data after enrollment related to delivery, logistics or medical outcomes.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3243}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-17', 'studyFirstSubmitDate': '2012-11-22', 'resultsFirstSubmitDate': '2016-01-08', 'studyFirstSubmitQcDate': '2012-11-26', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-17', 'studyFirstPostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Delivering at a Study Site.', 'timeFrame': 'Baseline until average of 24 weeks', 'description': 'The percentage of subjects who delivered at the study site relative to the number of enrolled subjects was calculated'}, {'measure': 'Percentage of Subjects Delivering at a Non-study Site.', 'timeFrame': 'Baseline until average of 24 weeks', 'description': 'The percentage of subjects who delivered at a non-study site relative to the number of enrolled subjects was calculated.'}], 'secondaryOutcomes': [{'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)', 'description': '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.'}, {'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)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Health care access, Pregnant women'], 'conditions': ['Pregnancy, Newborn Health']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'WHO. Antenatal care in developing countries. Promises, achievements and missed opportunities. An analysis of trends, levels and differentials, 1990-2001. Geneva: 2003.'}, {'type': 'BACKGROUND', 'citation': 'Assembly UNG. A world fit for children. Outcome document of the Special Session on Children. New York: 2002.'}, {'pmid': '19106756', 'type': 'BACKGROUND', '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.'}, {'pmid': '29334920', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "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:\n\n* Logistics of transportation to the study site (type, time it takes, cost incurred)\n* Accessibility to a telephone/cell phone\n* Provisions of alternative child care during site visits if there are other children under the subject's care"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women of gestational age 24 weeks or more', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Pregnant women with gestational age of greater than or equal to 24 weeks at the time of enrollment\n2. 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\n3. Pregnant women of gestational age between 28 weeks and 34 weeks 6/7 days\n\nExclusion Criteria:\n\nNone"}, 'identificationModule': {'nctId': 'NCT01734434', 'briefTitle': 'Study to Identify Factors Influencing Access of Pregnant Women and Their Infants to Local Healthcare Systems', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Observational Study to Identify Factors That Influence Access of Pregnant Women and Their Infants to Their Local Healthcare Systems', 'orgStudyIdInfo': {'id': 'V98_15OB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women', 'description': '24 weeks or more of gestation'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Centro Sanitario de Santo Domingo', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Maternidad Nuestra Senora de La Altagracia', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'city': 'Manhiça', 'country': 'Mozambique', 'facility': 'CISM Manhica Health Research Centre', 'geoPoint': {'lat': -25.40222, 'lon': 32.80722}}, {'city': 'Panama City', 'country': 'Panama', 'facility': 'Policentro Juan Diaz', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'city': 'Panama City', 'country': 'Panama', 'facility': 'Policentro Parque Lefevre', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'city': 'Panama City', 'country': 'Panama', 'facility': 'Policlínica JJ Vallarino', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'zip': '7500', 'city': 'Cape Town', 'country': 'South Africa', 'facility': "Children's Infectious Diseases Clinical Research Unit", 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '0152', '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'}], 'overallOfficials': [{'name': 'Novartis Vaccines and Diagnostics', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Vaccines'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}