Trial Outcomes & Findings for Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART) (NCT NCT00920621)
NCT ID: NCT00920621
Last Updated: 2026-05-12
Results Overview
Parental report of physician diagnosis of asthma or occurrence of recurrent wheeze in the child's first 3 years of life ascertained from questionnaires administered every 3 months. \*For some variables the "negative" count incorporates "negative and indeterminate."
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
876 participants
Primary outcome timeframe
First 3 years of life.
Results posted on
2026-05-12
Participant Flow
VDAART was a randomized, double-blind, placebo-controlled trial. Enrollment began October 2009 and completed follow-up January 2015 in 3 medical centers in the United Stated. 881 pregnant women age 18-39 at high risk for having children with asthma were randomized at 10-18 weeks gestation. 5 did not meet inclusion criteria and were removed.
Participant milestones
| Measure |
Vitamin D Treatment (Offspring)
Offspring of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D)
|
Placebo (Offspring)
Offspring of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control"
|
Placebo (Mothers)
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
Vitamin D Treatment (Mothers)
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
440
|
436
|
436
|
440
|
|
Overall Study
COMPLETED
|
405
|
401
|
391
|
386
|
|
Overall Study
NOT COMPLETED
|
35
|
35
|
45
|
54
|
Reasons for withdrawal
| Measure |
Vitamin D Treatment (Offspring)
Offspring of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D)
|
Placebo (Offspring)
Offspring of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control"
|
Placebo (Mothers)
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
Vitamin D Treatment (Mothers)
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
19
|
21
|
17
|
16
|
|
Overall Study
Fetal/neonatal deaths
|
16
|
14
|
14
|
16
|
|
Overall Study
Blood sample not collected
|
0
|
0
|
14
|
22
|
Baseline Characteristics
Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART)
Baseline characteristics by cohort
| Measure |
Vitamin D Treatment (Mothers)
n=440 Participants
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D)
|
Placebo (Mothers)
n=436 Participants
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
Vitamin D Treatment (Children)
n=405 Participants
Children of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
Placebo (Children)
n=401 Participants
Children of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
Total
n=3364 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27.5 years
STANDARD_DEVIATION 5.5 • n=440 Participants
|
27.3 years
STANDARD_DEVIATION 5.6 • n=436 Participants
|
0 years
STANDARD_DEVIATION 0 • n=405 Participants
|
0 years
STANDARD_DEVIATION 0 • n=401 Participants
|
27.4 years
STANDARD_DEVIATION 5.6 • n=1682 Participants
|
|
Sex: Female, Male
Female
|
440 Participants
n=440 Participants
|
436 Participants
n=436 Participants
|
204 Participants
n=405 Participants
|
181 Participants
n=401 Participants
|
1261 Participants
n=1682 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=440 Participants
|
0 Participants
n=436 Participants
|
201 Participants
n=405 Participants
|
220 Participants
n=401 Participants
|
421 Participants
n=1682 Participants
|
|
Race/Ethnicity, Customized
Black
|
190 Participants
n=440 Participants
|
190 Participants
n=436 Participants
|
199 Participants
n=405 Participants
|
191 Participants
n=401 Participants
|
770 Participants
n=1682 Participants
|
|
Race/Ethnicity, Customized
White Hispanic
|
59 Participants
n=440 Participants
|
61 Participants
n=436 Participants
|
53 Participants
n=405 Participants
|
51 Participants
n=401 Participants
|
224 Participants
n=1682 Participants
|
|
Race/Ethnicity, Customized
White non-Hispanic
|
114 Participants
n=440 Participants
|
116 Participants
n=436 Participants
|
82 Participants
n=405 Participants
|
79 Participants
n=401 Participants
|
391 Participants
n=1682 Participants
|
|
Race/Ethnicity, Customized
Other
|
77 Participants
n=440 Participants
|
69 Participants
n=436 Participants
|
71 Participants
n=405 Participants
|
80 Participants
n=401 Participants
|
297 Participants
n=1682 Participants
|
PRIMARY outcome
Timeframe: First 3 years of life.Population: Some measures have missing data due to collection, technical, and processing issues.
Parental report of physician diagnosis of asthma or occurrence of recurrent wheeze in the child's first 3 years of life ascertained from questionnaires administered every 3 months. \*For some variables the "negative" count incorporates "negative and indeterminate."
Outcome measures
| Measure |
Vitamin D Treatment
n=405 Participants
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
Placebo
n=401 Participants
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
|---|---|---|
|
Asthma or Recurrent Wheeze in First 3 Years of Life
Children positive
|
98 Participants
|
120 Participants
|
|
Asthma or Recurrent Wheeze in First 3 Years of Life
Children negative
|
307 Participants
|
281 Participants
|
PRIMARY outcome
Timeframe: 32-38 weeks gestationPopulation: Some measures have missing data due to collection, technical, and processing issues.
Maternal serum 25-hydroxyvitamin D measurement at third trimester during pregnancy
Outcome measures
| Measure |
Vitamin D Treatment
n=386 Participants
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
Placebo
n=391 Participants
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
|---|---|---|
|
Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling.
25(OH)D level of ≥ 30 ng/mL , women positive
|
289 Participants
|
133 Participants
|
|
Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling.
25(OH)D level of ≥ 30 ng/mL , women negative
|
97 Participants
|
258 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Some measures have missing data due to collection, technical, and processing issues.
Child positive-specific IgE tests from blood collection at 3 year visit.
Outcome measures
| Measure |
Vitamin D Treatment
n=3876 completed tests
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
Placebo
n=3651 completed tests
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
|---|---|---|
|
Child Positive-specific IgE Tests From Blood Collection at 3 Year Visit.
|
414 Positive-specific IgE tests
|
452 Positive-specific IgE tests
|
SECONDARY outcome
Timeframe: 1 year visitPopulation: Some measures have missing data due to collection, technical, and processing issues.
Child serum 25-hydroxyvitamin D measurement from blood collection at 1 year visit.
Outcome measures
| Measure |
Vitamin D Treatment
n=322 Participants
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
Placebo
n=309 Participants
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
|---|---|---|
|
Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 1 Year Visit.
|
29.3 ng/mL
Standard Deviation 9.2
|
30.1 ng/mL
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: Child's first 3 years of life.Population: Some measures have missing data due to collection, technical, and processing issues.
Parental report of physician diagnosis of eczema with rash in typical distribution in the child's first 3 years of life ascertained from questionnaires administered every 3 months. \*For some variables the "negative" count incorporates "negative and indeterminate."
Outcome measures
| Measure |
Vitamin D Treatment
n=405 Participants
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
Placebo
n=401 Participants
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
|---|---|---|
|
Parental Report of Physician Diagnosed Eczema (With Rash) in the Child's First 3 Years of Life.
Children positive
|
83 Participants
|
89 Participants
|
|
Parental Report of Physician Diagnosed Eczema (With Rash) in the Child's First 3 Years of Life.
Children negative
|
322 Participants
|
312 Participants
|
SECONDARY outcome
Timeframe: Child's first 3 years of life.Population: Some measures have missing data due to collection, technical, and processing issues.
Parental report of physician diagnosis of lower respiratory tract infection (LRI) in the child's first 3 years of life. LRI defined as physician diagnosed bronchitis, bronchiolitis, croup, or pneumonia ascertained from questionnaires administered every 3 months.
Outcome measures
| Measure |
Vitamin D Treatment
n=405 Participants
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
Placebo
n=401 Participants
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
|---|---|---|
|
Parental Report of Physician Diagnosis of Lower Respiratory Tract Infection in the Child's First 3 Years of Life.
|
222 Number of lower respiratory infections
|
276 Number of lower respiratory infections
|
SECONDARY outcome
Timeframe: Blood collection at childs' 3 year visit.Population: Some measures have missing data due to collection, technical, and processing issues.
Child serum 25-hydroxyvitamin D measurement from blood collection at 3 year visit.
Outcome measures
| Measure |
Vitamin D Treatment
n=289 Participants
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
Placebo
n=271 Participants
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
|---|---|---|
|
Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 3 Year Visit.
|
21.3 ng/mL
Standard Deviation 10.4
|
21.5 ng/mL
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Child's first 3 years of life.Population: Some measures have missing data due to collection, technical, and processing issues.
Any allergic sensitization in the child's first 3 years of life. \*For some variables the "negative" count incorporates "negative and indeterminate."
Outcome measures
| Measure |
Vitamin D Treatment
n=278 Participants
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
Placebo
n=261 Participants
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
|---|---|---|
|
Any Allergic Sensitization in the Child's First 3 Years of Life.
No sensitization
|
132 Participants
|
117 Participants
|
|
Any Allergic Sensitization in the Child's First 3 Years of Life.
Any sensitization
|
146 Participants
|
144 Participants
|
SECONDARY outcome
Timeframe: Blood collection at deliveryPopulation: Some measures have missing data due to collection, technical, and processing issues.
Mass Spec Vitamin D value from cord blood at delivery
Outcome measures
| Measure |
Vitamin D Treatment
n=303 Participants
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
Placebo
n=316 Participants
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
|---|---|---|
|
Mass Spec Vitamin D Value From Cord Blood at Delivery
|
28.2 ng/mL
Standard Deviation 12.4
|
19.1 ng/mL
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Some measures have missing data due to collection, technical, and processing issues.
Mass spec measured relative abundance of five metabolites of the sphingolipid metabolism pathway in plasma samples extracted at the year one visit.
Outcome measures
| Measure |
Vitamin D Treatment
n=211 Participants
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
Placebo
n=202 Participants
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
|---|---|---|
|
Sphingolipid Profile
sphinganine-1-phosphate
|
0.32 relative abundance (no units)
Standard Deviation 0.10
|
0.32 relative abundance (no units)
Standard Deviation 0.10
|
|
Sphingolipid Profile
sphinganine
|
0.33 relative abundance (no units)
Standard Deviation 0.20
|
0.31 relative abundance (no units)
Standard Deviation 0.18
|
|
Sphingolipid Profile
phosphoethanolamine
|
0.33 relative abundance (no units)
Standard Deviation 0.13
|
0.34 relative abundance (no units)
Standard Deviation 0.13
|
|
Sphingolipid Profile
sphingosine
|
0.34 relative abundance (no units)
Standard Deviation 0.17
|
0.33 relative abundance (no units)
Standard Deviation 0.17
|
|
Sphingolipid Profile
sphingosine-1-phosphate
|
0.31 relative abundance (no units)
Standard Deviation 0.06
|
0.32 relative abundance (no units)
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Some measures have missing data due to collection, technical, and processing issues.
Mass spec measured relative abundance of five metabolites of the sphingolipid metabolism pathway in plasma samples extracted at the year three visit.
Outcome measures
| Measure |
Vitamin D Treatment
n=179 Participants
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
Placebo
n=174 Participants
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
|---|---|---|
|
Sphingolipid Profile
sphinganine-1-phosphate
|
0.34 relative abundance (no units)
Standard Deviation 0.12
|
0.32 relative abundance (no units)
Standard Deviation 0.12
|
|
Sphingolipid Profile
sphinganine
|
0.39 relative abundance (no units)
Standard Deviation 0.20
|
0.37 relative abundance (no units)
Standard Deviation 0.20
|
|
Sphingolipid Profile
phosphoethanolamine
|
0.31 relative abundance (no units)
Standard Deviation 0.11
|
0.30 relative abundance (no units)
Standard Deviation 0.11
|
|
Sphingolipid Profile
sphingosine
|
0.38 relative abundance (no units)
Standard Deviation 0.19
|
0.37 relative abundance (no units)
Standard Deviation 0.19
|
|
Sphingolipid Profile
sphingosine-1-phosphate
|
0.31 relative abundance (no units)
Standard Deviation 0.07
|
0.30 relative abundance (no units)
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Some measures have missing data due to collection, technical, and processing issues.
Genotype at the rs12936231 SNP
Outcome measures
| Measure |
Vitamin D Treatment
n=311 Participants
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
Placebo
n=307 Participants
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
|---|---|---|
|
Child 17q21 Genotype
CC
|
93 Participants
|
78 Participants
|
|
Child 17q21 Genotype
GC
|
152 Participants
|
161 Participants
|
|
Child 17q21 Genotype
GG
|
66 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: Mother at 32-38 weeks gestation, Child's first 6 years of lifeWe extracted DNA and sequenced the bacterial 16S V4 hyper-variable region. The average number of 16S region reads sequenced per participant is provided here. Prior evidence suggests that read counts of at least 1,000 are adequate for 16S fecal microbiome profiling (Reference: Momozawa Y, et cal. Characterization of bacteria in biopsies of colon and stools by high throughput sequencing of the V2 region of bacterial 16S rRNA gene in human. PLoS One. 2011 Feb 10;6(2):e16952.)
Outcome measures
| Measure |
Vitamin D Treatment
n=696 Samples
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
Placebo
n=631 Samples
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
|---|---|---|
|
Fecal Microbiome Profile
Mother at 32-38 weeks gestation
|
10787 read counts
Standard Deviation 3534
|
10773 read counts
Standard Deviation 2511
|
|
Fecal Microbiome Profile
Child at 3-6 months
|
13443 read counts
Standard Deviation 8624
|
14024 read counts
Standard Deviation 9010
|
|
Fecal Microbiome Profile
Child at 1 year
|
11709 read counts
Standard Deviation 4202
|
11635 read counts
Standard Deviation 3488
|
|
Fecal Microbiome Profile
Child at 3 years
|
12095 read counts
Standard Deviation 4733
|
12407 read counts
Standard Deviation 4288
|
|
Fecal Microbiome Profile
Child at 4 years
|
0 read counts
Standard Deviation 0
|
0 read counts
Standard Deviation 0
|
|
Fecal Microbiome Profile
Child at 5 years
|
0 read counts
Standard Deviation 0
|
0 read counts
Standard Deviation 0
|
|
Fecal Microbiome Profile
Child at 6 years
|
0 read counts
Standard Deviation 0
|
0 read counts
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Late pregnancy (32-38 week's gestation)Population: Participants with non-missing late pregnancy 25(OH)D measurements. BMI categories defined as \<25, 25-29.9, and \>=30 (kg/m2)
Number and proportion of participants with late-pregnancy 25(OH)D concentrations below thresholds \<50 nmol/L and \<75 nmol/L, summarized by maternal BMI category at enrollment and treatment arm. Late pregnancy 25(OH)D concentrations were converted from ng/mL to nmol/L using a factor of 2.5.
Outcome measures
| Measure |
Vitamin D Treatment
n=362 Participants
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
Placebo
n=378 Participants
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
|---|---|---|
|
Proportion of Participants With Late-Pregnancy 25(OH)D Below Clinically Relevant Thresholds, by Maternal BMI Category
Threshold 1: Late pregnancy 25 (OH)D <50 nmol/L, BMI <25 kg/m2 · BMI >= 30 kg/m2
|
6 participants
|
30 participants
|
|
Proportion of Participants With Late-Pregnancy 25(OH)D Below Clinically Relevant Thresholds, by Maternal BMI Category
Threshold 1: Late pregnancy 25 (OH)D <50 nmol/L, BMI 25-29.9 kg/m2 · BMI >= 30 kg/m2
|
12 participants
|
29 participants
|
|
Proportion of Participants With Late-Pregnancy 25(OH)D Below Clinically Relevant Thresholds, by Maternal BMI Category
Threshold 1: Late pregnancy 25 (OH)D <50 nmol/L, BMI >=30 kg/m2 · BMI >= 30 kg/m2
|
20 participants
|
50 participants
|
|
Proportion of Participants With Late-Pregnancy 25(OH)D Below Clinically Relevant Thresholds, by Maternal BMI Category
Threshold 2: Late pregnancy 25 (OH)D <75 nmol/L, BMI <25 kg/m2 · BMI >= 30 kg/m2
|
20 participants
|
82 participants
|
|
Proportion of Participants With Late-Pregnancy 25(OH)D Below Clinically Relevant Thresholds, by Maternal BMI Category
Threshold 2: Late pregnancy 25 (OH)D <75 nmol/L, BMI 25-29.9 kg/m2 · BMI >= 30 kg/m2
|
23 participants
|
71 participants
|
|
Proportion of Participants With Late-Pregnancy 25(OH)D Below Clinically Relevant Thresholds, by Maternal BMI Category
Threshold 2: Late pregnancy 25 (OH)D <75 nmol/L, BMI >=30 kg/m2 · BMI >= 30 kg/m2
|
44 participants
|
97 participants
|
Adverse Events
Vitamin D Treatment (Mothers)
Serious events: 75 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (Mothers)
Serious events: 77 serious events
Other events: 0 other events
Deaths: 1 deaths
Vitamin D Treatment (Offspring)
Serious events: 58 serious events
Other events: 0 other events
Deaths: 3 deaths
Placebo (Offspring)
Serious events: 52 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Vitamin D Treatment (Mothers)
n=440 participants at risk
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
Placebo (Mothers)
n=436 participants at risk
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
Vitamin D Treatment (Offspring)
n=440 participants at risk
Offspring of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
|
Placebo (Offspring)
n=436 participants at risk
Offspring of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
HELLP
|
0.45%
2/440 • Number of events 2 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.23%
1/436 • Number of events 1 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.00%
0/440 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.00%
0/436 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
|
Pregnancy, puerperium and perinatal conditions
Preeclampsia
|
7.7%
34/440 • Number of events 36 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
8.5%
37/436 • Number of events 38 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.00%
0/440 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.00%
0/436 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
|
General disorders
Hospitalization
|
7.3%
32/440 • Number of events 42 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
7.3%
32/436 • Number of events 45 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.00%
0/440 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.00%
0/436 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
|
General disorders
Postpartum Hospitalization
|
1.6%
7/440 • Number of events 10 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
1.4%
6/436 • Number of events 8 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.00%
0/440 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.00%
0/436 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-term delivery <32 weeks gestation
|
0.00%
0/440 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.00%
0/436 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.68%
3/440 • Number of events 5 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
1.6%
7/436 • Number of events 11 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
|
General disorders
Maternal Death
|
0.00%
0/440 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.23%
1/436 • Number of events 1 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.00%
0/440 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.00%
0/436 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
|
Pregnancy, puerperium and perinatal conditions
Major fetal or congenital anomaly
|
0.00%
0/440 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.00%
0/436 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
2.3%
10/440 • Number of events 17 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
3.0%
13/436 • Number of events 14 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
|
General disorders
NICU
|
0.00%
0/440 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.00%
0/436 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
6.6%
29/440 • Number of events 36 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
4.1%
18/436 • Number of events 28 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
|
Pregnancy, puerperium and perinatal conditions
Still birth or intrauterine fetal death
|
0.00%
0/440 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.00%
0/436 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
3.0%
13/440 • Number of events 13 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
2.5%
11/436 • Number of events 11 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal demise
|
0.00%
0/440 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.00%
0/436 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.68%
3/440 • Number of events 3 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
0.69%
3/436 • Number of events 3 • From the point mothers entered the study until 2 years post delivery.
Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place