Trial Outcomes & Findings for Study to Identify Factors Influencing Access of Pregnant Women and Their Infants to Local Healthcare Systems (NCT NCT01734434)
NCT ID: NCT01734434
Last Updated: 2018-12-11
Results Overview
The percentage of subjects who delivered at the study site relative to the number of enrolled subjects was calculated
Recruitment status
COMPLETED
Target enrollment
3243 participants
Primary outcome timeframe
Baseline until average of 24 weeks
Results posted on
2018-12-11
Participant Flow
Subjects were enrolled at Dominican Republic, Panama, Mozambique, and South Africa.
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
Maternal Subjects (Dominican Republic)
Pregnant women who were enrolled in Dominican Republic.
|
Maternal Subjects (Panama)
Pregnant women who were enrolled in Panama.
|
Maternal Subjects (South Africa)
Pregnant women who were enrolled in South Africa.
|
Maternal Subjects (Mozambique)
Pregnant women who were enrolled in Mozambique.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
500
|
500
|
1992
|
251
|
|
Overall Study
COMPLETED
|
490
|
488
|
1863
|
228
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
129
|
23
|
Reasons for withdrawal
| Measure |
Maternal Subjects (Dominican Republic)
Pregnant women who were enrolled in Dominican Republic.
|
Maternal Subjects (Panama)
Pregnant women who were enrolled in Panama.
|
Maternal Subjects (South Africa)
Pregnant women who were enrolled in South Africa.
|
Maternal Subjects (Mozambique)
Pregnant women who were enrolled in Mozambique.
|
|---|---|---|---|---|
|
Overall Study
Death Infant
|
3
|
1
|
17
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
9
|
67
|
11
|
|
Overall Study
No Live Birth
|
1
|
2
|
32
|
6
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
8
|
1
|
|
Overall Study
Signed Adult Version of Consent Form
|
0
|
0
|
1
|
0
|
|
Overall Study
Subject Not Reachable
|
0
|
0
|
1
|
0
|
|
Overall Study
Treatment Defaulter
|
0
|
0
|
1
|
0
|
|
Overall Study
Wrong Version of Consent Form Signed
|
0
|
0
|
1
|
0
|
|
Overall Study
17 Yr Old Subject Signed Consent form
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Identify Factors Influencing Access of Pregnant Women and Their Infants to Local Healthcare Systems
Baseline characteristics by cohort
| Measure |
Maternal Subjects (Dominican Republic)
n=500 Participants
Pregnant women who were enrolled in Dominican Republic.
|
Maternal Subjects (Panama)
n=500 Participants
Pregnant women who were enrolled in Panama.
|
Maternal Subjects (South Africa)
n=1989 Participants
Pregnant women who were enrolled in South Africa.
|
Maternal Subjects (Mozambique)
n=251 Participants
Pregnant women who were enrolled in Mozambique.
|
Total
n=3240 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
24.49 Years
STANDARD_DEVIATION 5.28 • n=5 Participants
|
25.08 Years
STANDARD_DEVIATION 5.65 • n=7 Participants
|
27.05 Years
STANDARD_DEVIATION 6.05 • n=5 Participants
|
25.01 Years
STANDARD_DEVIATION 6.26 • n=4 Participants
|
26.19 Years
STANDARD_DEVIATION 5.99 • n=21 Participants
|
|
Sex: Female, Male
Female
|
500 Participants
n=5 Participants
|
500 Participants
n=7 Participants
|
1989 Participants
n=5 Participants
|
251 Participants
n=4 Participants
|
3240 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline until average of 24 weeksPopulation: 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.
The percentage of subjects who delivered at the study site relative to the number of enrolled subjects was calculated
Outcome measures
| Measure |
Maternal Subjects (Dominican Republic)
n=500 Participants
Pregnant women who were enrolled in Dominican Republic.
|
Maternal Subjects (Panama)
n=500 Participants
Pregnant women who were enrolled in Panama.
|
Maternal Subjects (South Africa)
n=1989 Participants
Pregnant women who were enrolled in South Africa.
|
Maternal Subjects (Mozambique)
n=251 Participants
Pregnant women who were enrolled in Mozambique.
|
|---|---|---|---|---|
|
Percentage of Subjects Delivering at a Study Site.
Subjects with known delivery information
|
99.20 Percentages of subjects
Interval 97.96 to 99.78
|
100 Percentages of subjects
Interval 99.26 to 100.0
|
99.65 Percentages of subjects
Interval 99.28 to 99.86
|
100 Percentages of subjects
Interval 98.54 to 100.0
|
|
Percentage of Subjects Delivering at a Study Site.
Study site delivery
|
68.55 Percentages of subjects
Interval 64.26 to 72.61
|
74.40 Percentages of subjects
Interval 70.34 to 78.17
|
56.66 Percentages of subjects
Interval 54.44 to 58.86
|
86.85 Percentages of subjects
Interval 82.03 to 90.77
|
PRIMARY outcome
Timeframe: Baseline until average of 24 weeksPopulation: Analysis was done on FAS.
The percentage of subjects who delivered at a non-study site relative to the number of enrolled subjects was calculated.
Outcome measures
| Measure |
Maternal Subjects (Dominican Republic)
n=500 Participants
Pregnant women who were enrolled in Dominican Republic.
|
Maternal Subjects (Panama)
n=500 Participants
Pregnant women who were enrolled in Panama.
|
Maternal Subjects (South Africa)
n=1989 Participants
Pregnant women who were enrolled in South Africa.
|
Maternal Subjects (Mozambique)
n=251 Participants
Pregnant women who were enrolled in Mozambique.
|
|---|---|---|---|---|
|
Percentage of Subjects Delivering at a Non-study Site.
Subjects with known delivery information
|
99.20 Percentages of subjects
Interval 97.96 to 99.78
|
100 Percentages of subjects
Interval 99.26 to 100.0
|
99.65 Percentages of subjects
Interval 99.28 to 99.86
|
100 Percentages of subjects
Interval 98.54 to 100.0
|
|
Percentage of Subjects Delivering at a Non-study Site.
Non-study healthcare facility
|
30.85 Percentages of subjects
Interval 26.81 to 35.12
|
24.60 Percentages of subjects
Interval 20.88 to 28.62
|
41.32 Percentages of subjects
Interval 39.14 to 43.53
|
7.97 Percentages of subjects
Interval 4.93 to 12.04
|
|
Percentage of Subjects Delivering at a Non-study Site.
Home
|
0 Percentages of subjects
Interval 0.0 to 0.0
|
0.40 Percentages of subjects
Interval 0.05 to 1.44
|
0.76 Percentages of subjects
Interval 0.42 to 1.25
|
2.79 Percentages of subjects
Interval 1.13 to 5.66
|
|
Percentage of Subjects Delivering at a Non-study Site.
Other
|
0 Percentages of subjects
Interval 0.0 to 0.0
|
0 Percentages of subjects
Interval 0.0 to 0.0
|
0.50 Percentages of subjects
Interval 0.24 to 0.93
|
0.40 Percentages of subjects
Interval 0.01 to 2.2
|
|
Percentage of Subjects Delivering at a Non-study Site.
Unknown
|
0.60 Percentages of subjects
Interval 0.12 to 1.76
|
0.60 Percentages of subjects
Interval 0.12 to 1.74
|
0.76 Percentages of subjects
Interval 0.42 to 1.25
|
1.99 Percentages of subjects
Interval 0.65 to 4.59
|
SECONDARY outcome
Timeframe: Delivery to Day 90 post-delivery (Infant follow-up)Population: Analysis was done on the FAS
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.
Outcome measures
| Measure |
Maternal Subjects (Dominican Republic)
n=493 Participants
Pregnant women who were enrolled in Dominican Republic.
|
Maternal Subjects (Panama)
n=498 Participants
Pregnant women who were enrolled in Panama.
|
Maternal Subjects (South Africa)
n=1966 Participants
Pregnant women who were enrolled in South Africa.
|
Maternal Subjects (Mozambique)
n=242 Participants
Pregnant women who were enrolled in Mozambique.
|
|---|---|---|---|---|
|
Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site.
Live births at discharge
|
493 participants
|
498 participants
|
1966 participants
|
242 participants
|
|
Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site.
Infants reported sick
|
58 participants
|
81 participants
|
74 participants
|
5 participants
|
|
Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site.
Infants brought to health care facility-study site
|
54 participants
|
147 participants
|
27 participants
|
51 participants
|
SECONDARY outcome
Timeframe: Delivery to Day 90 post-delivery (Infant follow-up)Population: Analysis was performed on the FAS.
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.
Outcome measures
| Measure |
Maternal Subjects (Dominican Republic)
n=493 Participants
Pregnant women who were enrolled in Dominican Republic.
|
Maternal Subjects (Panama)
n=498 Participants
Pregnant women who were enrolled in Panama.
|
Maternal Subjects (South Africa)
n=1966 Participants
Pregnant women who were enrolled in South Africa.
|
Maternal Subjects (Mozambique)
n=242 Participants
Pregnant women who were enrolled in Mozambique.
|
|---|---|---|---|---|
|
Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery)
|
479 participants
|
333 participants
|
1163 participants
|
146 participants
|
Adverse Events
Maternal Subjects (Dominican Republic)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Maternal Subjects (Panama)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Maternal Subjects (South Africa)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Maternal Subjects (Mozambique)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60