Trial Outcomes & Findings for Determinants of Gestational Weight Gain in Obese Pregnant Women (NCT NCT01954342)
NCT ID: NCT01954342
Last Updated: 2021-09-16
Results Overview
Energy intake is determined using the energy intake-balance method. Energy intake was calculated as the sum of energy expenditure by doubly labeled water and energy deposition of fat and fat-free tissues by 3 compartment model using plethysmography and isotope dilution.
Recruitment status
COMPLETED
Target enrollment
72 participants
Primary outcome timeframe
Approximately 6 months (from 13-16 weeks gestation to 35-37 weeks gestation)
Results posted on
2021-09-16
Participant Flow
Participant milestones
| Measure |
Pregnant Women With Excess Gestational Weight Gain
Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Recommended Gestational Weight Gain
Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Inadequate Gestational Weight Gain
Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women Not Included in Analysis
Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
8
|
10
|
18
|
|
Overall Study
COMPLETED
|
36
|
8
|
10
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
18
|
Reasons for withdrawal
| Measure |
Pregnant Women With Excess Gestational Weight Gain
Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Recommended Gestational Weight Gain
Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Inadequate Gestational Weight Gain
Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women Not Included in Analysis
Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
|
|---|---|---|---|---|
|
Overall Study
Missing data from 13-16week study visit
|
0
|
0
|
0
|
1
|
|
Overall Study
Miscarriage
|
0
|
0
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
5
|
|
Overall Study
Preterm delivery
|
0
|
0
|
0
|
3
|
|
Overall Study
Pre-eclampsia
|
0
|
0
|
0
|
4
|
|
Overall Study
Unreliable Data
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Determinants of Gestational Weight Gain in Obese Pregnant Women
Baseline characteristics by cohort
| Measure |
Pregnant Women With Excess Gestational Weight Gain
n=36 Participants
Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Recommended Gestational Weight Gain
n=8 Participants
Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Inadequate Gestational Weight Gain
n=10 Participants
Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women Not Included in Analysis
n=18 Participants
Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27.7 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
25 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
29.2 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
28.2 years
STANDARD_DEVIATION 6.1 • n=4 Participants
|
27.7 years
STANDARD_DEVIATION 5.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
72 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Parity
0 viable pregnancies
|
16 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Parity
1 viable pregnancies
|
14 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Parity
2 viable pregnancies
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Parity
≥3 viable pregnancies
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Body Mass Index
|
34.8 kg/m^2
STANDARD_DEVIATION 3.0 • n=5 Participants
|
34.6 kg/m^2
STANDARD_DEVIATION 4.5 • n=7 Participants
|
40.6 kg/m^2
STANDARD_DEVIATION 7.9 • n=5 Participants
|
41.0 kg/m^2
STANDARD_DEVIATION 6.3 • n=4 Participants
|
37.1 kg/m^2
STANDARD_DEVIATION 5.7 • n=21 Participants
|
|
Highest Education
Less than high school
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Highest Education
High school
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Highest Education
1-3 years college
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Highest Education
College degree
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Highest Education
Postgraduate work
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Approximately 6 months (from 13-16 weeks gestation to 35-37 weeks gestation)Population: Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis). Reasons include the following: missing necessary data from either the 13-16 weeks gestation or 35-37 weeks gestation visit, pre-eclampsia, or unreliable data.
Energy intake is determined using the energy intake-balance method. Energy intake was calculated as the sum of energy expenditure by doubly labeled water and energy deposition of fat and fat-free tissues by 3 compartment model using plethysmography and isotope dilution.
Outcome measures
| Measure |
Pregnant Women With Excess Gestational Weight Gain
n=36 Participants
Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Recommended Gestational Weight Gain
n=8 Participants
Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Inadequate Gestational Weight Gain
n=10 Participants
Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women Not Included in Analysis
Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
|
|---|---|---|---|---|
|
Energy Intake
|
2908 kilocalories per day
Standard Deviation 384
|
2698 kilocalories per day
Standard Deviation 280
|
2581 kilocalories per day
Standard Deviation 417
|
—
|
SECONDARY outcome
Timeframe: Approximately 7 days within 13-16 weeks gestationPopulation: Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis). Reasons include the following: missing necessary data from either the 13-16 weeks gestation or 35-37 weeks gestation visit, pre-eclampsia, or unreliable data.
Physical activity is determined using daily mean amplitude deviation in milligrams by wrist worn accelerometer over a period of approximately 7 days within early pregnancy (13-16 weeks gestation). Mean amplitude deviation describes the mean distance of data points from the mean, and higher values denote higher levels of physical activity.
Outcome measures
| Measure |
Pregnant Women With Excess Gestational Weight Gain
n=36 Participants
Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Recommended Gestational Weight Gain
n=8 Participants
Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Inadequate Gestational Weight Gain
n=10 Participants
Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women Not Included in Analysis
Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
|
|---|---|---|---|---|
|
Physical Activity
|
53.8 milligrams
Standard Deviation 10.2
|
56.4 milligrams
Standard Deviation 6.5
|
46.6 milligrams
Standard Deviation 9.8
|
—
|
SECONDARY outcome
Timeframe: Approximately 7 days within 35-37 weeks gestationPopulation: Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis). Reasons include the following: missing necessary data from either the 13-16 weeks gestation or 35-37 weeks gestation visit, pre-eclampsia, or unreliable data.
Physical activity is determined using daily mean amplitude deviation in milligrams by wrist worn accelerometer over a period of approximately 7 days within late pregnancy (35-37 weeks gestation). Mean amplitude deviation describes the mean distance of data points from the mean, and higher values denote higher levels of physical activity.
Outcome measures
| Measure |
Pregnant Women With Excess Gestational Weight Gain
n=36 Participants
Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Recommended Gestational Weight Gain
n=8 Participants
Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Inadequate Gestational Weight Gain
n=10 Participants
Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women Not Included in Analysis
Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
|
|---|---|---|---|---|
|
Physical Activity
|
47.5 milligrams
Standard Deviation 11.4
|
52.9 milligrams
Standard Deviation 10.7
|
41.4 milligrams
Standard Deviation 12.6
|
—
|
SECONDARY outcome
Timeframe: 1 day within 13-16 weeks gestationPopulation: Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis). Reasons include the following: missing necessary data from either the 13-16 weeks gestation or 35-37 weeks gestation visit, pre-eclampsia, or unreliable data.
Energy expenditure during sleep is determined by 1 overnight stay in a whole body calorimeter within early pregnancy (13-16 weeks gestation).
Outcome measures
| Measure |
Pregnant Women With Excess Gestational Weight Gain
n=36 Participants
Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Recommended Gestational Weight Gain
n=8 Participants
Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Inadequate Gestational Weight Gain
n=10 Participants
Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women Not Included in Analysis
Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
|
|---|---|---|---|---|
|
Energy Expenditure During Sleep
|
1648 kilocalories per day
Standard Deviation 198
|
1688 kilocalories per day
Standard Deviation 218
|
1907 kilocalories per day
Standard Deviation 329
|
—
|
SECONDARY outcome
Timeframe: 1 day within 35-37 weeks gestationPopulation: Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis). Reasons include the following: missing necessary data from either the 13-16 weeks gestation or 35-37 weeks gestation visit, pre-eclampsia, or unreliable data.
Energy expenditure during sleep is determined by 1 overnight stay in a whole body calorimeter within late pregnancy (35-37 weeks gestation).
Outcome measures
| Measure |
Pregnant Women With Excess Gestational Weight Gain
n=36 Participants
Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Recommended Gestational Weight Gain
n=8 Participants
Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Inadequate Gestational Weight Gain
n=10 Participants
Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women Not Included in Analysis
Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
|
|---|---|---|---|---|
|
Energy Expenditure During Sleep
|
1975 kilocalories per day
Standard Deviation 216
|
2081 kilocalories per day
Standard Deviation 288
|
2125 kilocalories per day
Standard Deviation 278
|
—
|
SECONDARY outcome
Timeframe: Approximately 7 days within 13-16 weeks gestationPopulation: Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis) for various reasons. In the analyzed Arms, some participants were not analyzed as energy intake by remote food photography method was less than 60% of the total energy expenditure during that period.
Percentage of protein of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).
Outcome measures
| Measure |
Pregnant Women With Excess Gestational Weight Gain
n=29 Participants
Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Recommended Gestational Weight Gain
n=5 Participants
Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Inadequate Gestational Weight Gain
n=5 Participants
Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women Not Included in Analysis
Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
|
|---|---|---|---|---|
|
Percentage of Protein of Energy Intake
|
15.3 percentage of energy intake
Standard Deviation 3.8
|
16.3 percentage of energy intake
Standard Deviation 3.6
|
18.9 percentage of energy intake
Standard Deviation 12.1
|
—
|
SECONDARY outcome
Timeframe: Approximately 7 days within 35-37 weeks gestationPopulation: Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis) for various reasons. In the analyzed Arms, some participants were not analyzed as energy intake by remote food photography method was less than 60% of the total energy expenditure during that period.
Percentage of protein of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation).
Outcome measures
| Measure |
Pregnant Women With Excess Gestational Weight Gain
n=29 Participants
Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Recommended Gestational Weight Gain
n=5 Participants
Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Inadequate Gestational Weight Gain
n=5 Participants
Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women Not Included in Analysis
Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
|
|---|---|---|---|---|
|
Percentage of Protein of Energy Intake
|
15.3 percentage of energy intake
Standard Deviation 4.3
|
16.1 percentage of energy intake
Standard Deviation 3.8
|
13.7 percentage of energy intake
Standard Deviation 3.1
|
—
|
SECONDARY outcome
Timeframe: Approximately 7 days within 13-16 weeks gestationPopulation: Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis) for various reasons. In the analyzed Arms, some participants were not analyzed as energy intake by remote food photography method was less than 60% of the total energy expenditure during that period.
Percentage of fat of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).
Outcome measures
| Measure |
Pregnant Women With Excess Gestational Weight Gain
n=29 Participants
Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Recommended Gestational Weight Gain
n=5 Participants
Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Inadequate Gestational Weight Gain
n=5 Participants
Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women Not Included in Analysis
Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
|
|---|---|---|---|---|
|
Percentage of Fat of Energy Intake
|
38.1 percentage of energy intake
Standard Deviation 4.3
|
38.0 percentage of energy intake
Standard Deviation 5.8
|
34.0 percentage of energy intake
Standard Deviation 5.6
|
—
|
SECONDARY outcome
Timeframe: Approximately 7 days within 35-37 weeks gestationPopulation: Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis) for various reasons. In the analyzed Arms, some participants were not analyzed as energy intake by remote food photography method was less than 60% of the total energy expenditure during that period.
Percentage of fat of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation).
Outcome measures
| Measure |
Pregnant Women With Excess Gestational Weight Gain
n=29 Participants
Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Recommended Gestational Weight Gain
n=5 Participants
Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Inadequate Gestational Weight Gain
n=5 Participants
Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women Not Included in Analysis
Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
|
|---|---|---|---|---|
|
Percentage of Fat of Energy Intake
|
38.3 percentage of energy intake
Standard Deviation 5.9
|
39.6 percentage of energy intake
Standard Deviation 6.0
|
34.6 percentage of energy intake
Standard Deviation 5.6
|
—
|
SECONDARY outcome
Timeframe: Approximately 7 days within 13-16 weeks gestationPopulation: Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis) for various reasons. In the analyzed Arms, some participants were not analyzed as energy intake by remote food photography method was less than 60% of the total energy expenditure during that period.
Percentage of carbohydrate of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).
Outcome measures
| Measure |
Pregnant Women With Excess Gestational Weight Gain
n=29 Participants
Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Recommended Gestational Weight Gain
n=5 Participants
Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Inadequate Gestational Weight Gain
n=5 Participants
Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women Not Included in Analysis
Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
|
|---|---|---|---|---|
|
Percentage of Carbohydrate of Energy Intake
|
47.6 percentage of energy intake
Standard Deviation 7.0
|
46.6 percentage of energy intake
Standard Deviation 8.5
|
48.2 percentage of energy intake
Standard Deviation 12.3
|
—
|
SECONDARY outcome
Timeframe: Approximately 7 days within 35-37 weeks gestationPopulation: Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis) for various reasons. In the analyzed Arms, some participants were not analyzed as energy intake by remote food photography method was less than 60% of the total energy expenditure during that period.
Percentage of carbohydrate of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation).
Outcome measures
| Measure |
Pregnant Women With Excess Gestational Weight Gain
n=29 Participants
Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Recommended Gestational Weight Gain
n=5 Participants
Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Inadequate Gestational Weight Gain
n=5 Participants
Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women Not Included in Analysis
Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
|
|---|---|---|---|---|
|
Percentage of Carbohydrate of Energy Intake
|
47.4 percentage of energy intake
Standard Deviation 8.6
|
44.9 percentage of energy intake
Standard Deviation 8.0
|
52.7 percentage of energy intake
Standard Deviation 8.3
|
—
|
Adverse Events
Pregnant Women With Excess Gestational Weight Gain
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
Pregnant Women With Recommended Gestational Weight Gain
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Pregnant Women With Inadequate Gestational Weight Gain
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Pregnant Women Not Included in Analysis
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregnant Women With Excess Gestational Weight Gain
n=36 participants at risk
Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Recommended Gestational Weight Gain
n=8 participants at risk
Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Inadequate Gestational Weight Gain
n=10 participants at risk
Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women Not Included in Analysis
n=18 participants at risk
Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage or Pregnancy Loss
|
2.8%
1/36 • Number of events 1 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
16.7%
3/18 • Number of events 3 • 1 year 6 months
|
|
Musculoskeletal and connective tissue disorders
hip pain
|
2.8%
1/36 • Number of events 1 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Nervous system disorders
Aphasia
|
2.8%
1/36 • Number of events 1 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Infections and infestations
Kidney infection
|
0.00%
0/36 • 1 year 6 months
|
12.5%
1/8 • Number of events 1 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Nervous system disorders
Vertigo
|
0.00%
0/36 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
5.6%
1/18 • Number of events 1 • 1 year 6 months
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/36 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
5.6%
1/18 • Number of events 1 • 1 year 6 months
|
Other adverse events
| Measure |
Pregnant Women With Excess Gestational Weight Gain
n=36 participants at risk
Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Recommended Gestational Weight Gain
n=8 participants at risk
Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women With Inadequate Gestational Weight Gain
n=10 participants at risk
Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines
|
Pregnant Women Not Included in Analysis
n=18 participants at risk
Pregnant women who enrolled in the study but were not included in data analysis for various reasons.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cold/sinus congestion
|
38.9%
14/36 • Number of events 18 • 1 year 6 months
|
25.0%
2/8 • Number of events 3 • 1 year 6 months
|
40.0%
4/10 • Number of events 5 • 1 year 6 months
|
16.7%
3/18 • Number of events 3 • 1 year 6 months
|
|
Nervous system disorders
Headaches
|
13.9%
5/36 • Number of events 5 • 1 year 6 months
|
12.5%
1/8 • Number of events 1 • 1 year 6 months
|
30.0%
3/10 • Number of events 3 • 1 year 6 months
|
5.6%
1/18 • Number of events 1 • 1 year 6 months
|
|
Gastrointestinal disorders
Heartburn
|
19.4%
7/36 • Number of events 8 • 1 year 6 months
|
12.5%
1/8 • Number of events 1 • 1 year 6 months
|
40.0%
4/10 • Number of events 4 • 1 year 6 months
|
11.1%
2/18 • Number of events 2 • 1 year 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
9/36 • Number of events 9 • 1 year 6 months
|
50.0%
4/8 • Number of events 4 • 1 year 6 months
|
20.0%
2/10 • Number of events 2 • 1 year 6 months
|
5.6%
1/18 • Number of events 1 • 1 year 6 months
|
|
Endocrine disorders
Gestational Diabetes
|
8.3%
3/36 • Number of events 3 • 1 year 6 months
|
37.5%
3/8 • Number of events 3 • 1 year 6 months
|
20.0%
2/10 • Number of events 2 • 1 year 6 months
|
5.6%
1/18 • Number of events 1 • 1 year 6 months
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
19.4%
7/36 • Number of events 8 • 1 year 6 months
|
25.0%
2/8 • Number of events 2 • 1 year 6 months
|
50.0%
5/10 • Number of events 5 • 1 year 6 months
|
22.2%
4/18 • Number of events 4 • 1 year 6 months
|
|
Psychiatric disorders
Anxiety
|
11.1%
4/36 • Number of events 4 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
5.6%
1/18 • Number of events 1 • 1 year 6 months
|
|
Psychiatric disorders
Depression
|
11.1%
4/36 • Number of events 4 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
11.1%
2/18 • Number of events 2 • 1 year 6 months
|
|
Immune system disorders
Allergies
|
5.6%
2/36 • Number of events 2 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Cardiac disorders
Hypertension
|
5.6%
2/36 • Number of events 2 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
20.0%
2/10 • Number of events 2 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
2/36 • Number of events 2 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
5.6%
1/18 • Number of events 1 • 1 year 6 months
|
|
Infections and infestations
Urinary Tract Infection
|
11.1%
4/36 • Number of events 4 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
20.0%
2/10 • Number of events 2 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Musculoskeletal and connective tissue disorders
Abdominal Pain
|
5.6%
2/36 • Number of events 2 • 1 year 6 months
|
12.5%
1/8 • Number of events 1 • 1 year 6 months
|
20.0%
2/10 • Number of events 2 • 1 year 6 months
|
5.6%
1/18 • Number of events 1 • 1 year 6 months
|
|
Infections and infestations
Fungal Infection
|
5.6%
2/36 • Number of events 2 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Infections and infestations
Bacterial Infection
|
8.3%
3/36 • Number of events 3 • 1 year 6 months
|
12.5%
1/8 • Number of events 1 • 1 year 6 months
|
10.0%
1/10 • Number of events 1 • 1 year 6 months
|
5.6%
1/18 • Number of events 1 • 1 year 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.8%
1/36 • Number of events 1 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
20.0%
2/10 • Number of events 2 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Musculoskeletal and connective tissue disorders
Body Pain
|
0.00%
0/36 • 1 year 6 months
|
25.0%
2/8 • Number of events 2 • 1 year 6 months
|
20.0%
2/10 • Number of events 2 • 1 year 6 months
|
11.1%
2/18 • Number of events 2 • 1 year 6 months
|
|
Gastrointestinal disorders
Stomach virus
|
2.8%
1/36 • Number of events 1 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
10.0%
1/10 • Number of events 1 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/36 • 1 year 6 months
|
12.5%
1/8 • Number of events 1 • 1 year 6 months
|
20.0%
2/10 • Number of events 2 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/36 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
10.0%
1/10 • Number of events 1 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/36 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
20.0%
2/10 • Number of events 2 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Nervous system disorders
Fainting
|
0.00%
0/36 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
10.0%
1/10 • Number of events 1 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/36 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
10.0%
1/10 • Number of events 1 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Musculoskeletal and connective tissue disorders
Carpal Tunnel
|
0.00%
0/36 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
10.0%
1/10 • Number of events 1 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Musculoskeletal and connective tissue disorders
Pelvin Pain
|
0.00%
0/36 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
10.0%
1/10 • Number of events 1 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Cardiac disorders
Hypotension
|
0.00%
0/36 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
10.0%
1/10 • Number of events 1 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
2.8%
1/36 • Number of events 1 • 1 year 6 months
|
12.5%
1/8 • Number of events 1 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Musculoskeletal and connective tissue disorders
Hip Pain
|
0.00%
0/36 • 1 year 6 months
|
12.5%
1/8 • Number of events 1 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
General disorders
Fatigue
|
0.00%
0/36 • 1 year 6 months
|
12.5%
1/8 • Number of events 1 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/36 • 1 year 6 months
|
12.5%
1/8 • Number of events 1 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Metabolism and nutrition disorders
Folate Deficiency
|
0.00%
0/36 • 1 year 6 months
|
12.5%
1/8 • Number of events 1 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
0.00%
0/18 • 1 year 6 months
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.00%
0/36 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
5.6%
1/18 • Number of events 1 • 1 year 6 months
|
|
Musculoskeletal and connective tissue disorders
Oral Pain
|
2.8%
1/36 • Number of events 1 • 1 year 6 months
|
25.0%
2/8 • Number of events 2 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
5.6%
1/18 • Number of events 1 • 1 year 6 months
|
|
Musculoskeletal and connective tissue disorders
Edema
|
0.00%
0/36 • 1 year 6 months
|
12.5%
1/8 • Number of events 1 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
11.1%
2/18 • Number of events 2 • 1 year 6 months
|
|
Blood and lymphatic system disorders
Cystic Hygroma
|
0.00%
0/36 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
5.6%
1/18 • Number of events 1 • 1 year 6 months
|
|
Metabolism and nutrition disorders
Protein Deficiency
|
0.00%
0/36 • 1 year 6 months
|
0.00%
0/8 • 1 year 6 months
|
0.00%
0/10 • 1 year 6 months
|
5.6%
1/18 • Number of events 1 • 1 year 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place