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

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ClinicalTrials.gov Identifier: NCT01734434
Recruitment Status : Completed
First Posted : November 27, 2012
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Observational
Study Design Observational Model: Ecologic or Community;   Time Perspective: Prospective
Condition Pregnancy, Newborn Health
Enrollment 3243
Recruitment Details Subjects were enrolled at Dominican Republic, Panama, Mozambique, and South Africa.
Pre-assignment Details All enrolled subjects were included in the trial.
Arm/Group Title Maternal Subjects (Dominican Republic) Maternal Subjects (Panama) Maternal Subjects (South Africa) Maternal Subjects (Mozambique)
Hide Arm/Group Description Pregnant women who were enrolled in Dominican Republic. Pregnant women who were enrolled in Panama. Pregnant women who were enrolled in South Africa. Pregnant women who were enrolled in Mozambique.
Period Title: Overall Study
Started 500 500 1992 251
Completed 490 488 1863 228
Not Completed 10 12 129 23
Reason Not Completed
Death Infant             3             1             17             5
Lost to Follow-up             2             9             67             11
No Live Birth             1             2             32             6
Withdrawal by Subject             4             0             8             1
Signed Adult Version of Consent Form             0             0             1             0
Subject Not Reachable             0             0             1             0
Treatment Defaulter             0             0             1             0
Wrong Version of Consent Form Signed             0             0             1             0
17 Yr Old Subject Signed Consent form             0             0             1             0
Arm/Group Title Maternal Subjects (Dominican Republic) Maternal Subjects (Panama) Maternal Subjects (South Africa) Maternal Subjects (Mozambique) Total
Hide Arm/Group Description Pregnant women who were enrolled in Dominican Republic. Pregnant women who were enrolled in Panama. Pregnant women who were enrolled in South Africa. Pregnant women who were enrolled in Mozambique. Total of all reporting groups
Overall Number of Baseline Participants 500 500 1989 251 3240
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 500 participants 500 participants 1989 participants 251 participants 3240 participants
24.49  (5.28) 25.08  (5.65) 27.05  (6.05) 25.01  (6.26) 26.19  (5.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants 500 participants 1989 participants 251 participants 3240 participants
Female
500
 100.0%
500
 100.0%
1989
 100.0%
251
 100.0%
3240
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Subjects Delivering at a Study Site.
Hide Description The percentage of subjects who delivered at the study site relative to the number of enrolled subjects was calculated
Time Frame Baseline until average of 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Maternal Subjects (Dominican Republic) Maternal Subjects (Panama) Maternal Subjects (South Africa) Maternal Subjects (Mozambique)
Hide Arm/Group Description:
Pregnant women who were enrolled in Dominican Republic.
Pregnant women who were enrolled in Panama.
Pregnant women who were enrolled in South Africa.
Pregnant women who were enrolled in Mozambique.
Overall Number of Participants Analyzed 500 500 1989 251
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Subjects with known delivery information
99.20
(97.96 to 99.78)
100
(99.26 to 100)
99.65
(99.28 to 99.86)
100
(98.54 to 100)
Study site delivery
68.55
(64.26 to 72.61)
74.40
(70.34 to 78.17)
56.66
(54.44 to 58.86)
86.85
(82.03 to 90.77)
2.Primary Outcome
Title Percentage of Subjects Delivering at a Non-study Site.
Hide Description The percentage of subjects who delivered at a non-study site relative to the number of enrolled subjects was calculated.
Time Frame Baseline until average of 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS.
Arm/Group Title Maternal Subjects (Dominican Republic) Maternal Subjects (Panama) Maternal Subjects (South Africa) Maternal Subjects (Mozambique)
Hide Arm/Group Description:
Pregnant women who were enrolled in Dominican Republic.
Pregnant women who were enrolled in Panama.
Pregnant women who were enrolled in South Africa.
Pregnant women who were enrolled in Mozambique.
Overall Number of Participants Analyzed 500 500 1989 251
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Subjects with known delivery information
99.20
(97.96 to 99.78)
100
(99.26 to 100)
99.65
(99.28 to 99.86)
100
(98.54 to 100)
Non-study healthcare facility
30.85
(26.81 to 35.12)
24.60
(20.88 to 28.62)
41.32
(39.14 to 43.53)
7.97
(4.93 to 12.04)
Home
0
(0 to 0)
0.40
(0.05 to 1.44)
0.76
(0.42 to 1.25)
2.79
(1.13 to 5.66)
Other
0
(0 to 0)
0
(0 to 0)
0.50
(0.24 to 0.93)
0.40
(0.01 to 2.20)
Unknown
0.60
(0.12 to 1.76)
0.60
(0.12 to 1.74)
0.76
(0.42 to 1.25)
1.99
(0.65 to 4.59)
3.Secondary Outcome
Title Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site.
Hide 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.
Time Frame Delivery to Day 90 post-delivery (Infant follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS
Arm/Group Title Maternal Subjects(Dominican Republic) Maternal Subjects(Panama) Maternal Subjects (South Africa) Maternal Subjects(Mozambique)
Hide Arm/Group Description:
pregnant women who were enrolled in Dominican Republic.
pregnant women who were enrolled in Panama.
pregnant women who were enrolled in South Africa.
pregnant women who were enrolled in Mozambique.
Overall Number of Participants Analyzed 493 498 1966 242
Measure Type: Number
Unit of Measure: participants
Live births at discharge 493 498 1966 242
Infants reported sick 58 81 74 5
Infants brought to health care facility-study site 54 147 27 51
4.Secondary Outcome
Title Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery)
Hide 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.
Time Frame Delivery to Day 90 post-delivery (Infant follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the FAS.
Arm/Group Title Infants (Dominican Republic) Infants (Panama) Infants (South Africa) Infants (Mozambique)
Hide Arm/Group Description:
Infants born to pregnant women who were enrolled in Dominican Republic, brought to study site for 90-day follow up.
Infants born to pregnant women who were enrolled in Panama, brought to study site for 90-day follow up.
Infants born to pregnant women who were enrolled in South Africa, brought to study site for 90-day follow up.
Infants born to pregnant women who were enrolled in Mozambique, brought to study site for 90-day follow up.
Overall Number of Participants Analyzed 493 498 1966 242
Measure Type: Number
Unit of Measure: participants
479 333 1163 146
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse event data were not collected.
 
Arm/Group Title Maternal Subjects (Dominican Republic) Maternal Subjects (Panama) Maternal Subjects (South Africa) Maternal Subjects (Mozambique)
Hide Arm/Group Description Pregnant women who were enrolled in Dominican Republic. Pregnant women who were enrolled in Panama. Pregnant women who were enrolled in South Africa. Pregnant women who were enrolled in Mozambique.
All-Cause Mortality
Maternal Subjects (Dominican Republic) Maternal Subjects (Panama) Maternal Subjects (South Africa) Maternal Subjects (Mozambique)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Maternal Subjects (Dominican Republic) Maternal Subjects (Panama) Maternal Subjects (South Africa) Maternal Subjects (Mozambique)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Maternal Subjects (Dominican Republic) Maternal Subjects (Panama) Maternal Subjects (South Africa) Maternal Subjects (Mozambique)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
EMail: RegistryContactVaccinesUS@novartis.com
Publications:
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.
Layout table for additonal information
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01734434     History of Changes
Other Study ID Numbers: V98_15OB
First Submitted: November 22, 2012
First Posted: November 27, 2012
Results First Submitted: January 8, 2016
Results First Posted: December 11, 2018
Last Update Posted: December 11, 2018