Trial Outcomes & Findings for Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility (NCT NCT02432209)
NCT ID: NCT02432209
Last Updated: 2022-02-03
Results Overview
Defined as a live birth of an infant born at ≥ 37 weeks, with a birth weight between 2500 and 4000g and without a major congenital anomaly
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
379 participants
Primary outcome timeframe
At time of birth, approximately 17 months into the study
Results posted on
2022-02-03
Participant Flow
Participant milestones
| Measure |
Intensive Lifestyle Mod. Intervention
The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.
Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.
Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
Standard Lifestyle Intervention
Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
|---|---|---|
|
Overall Study
STARTED
|
188
|
191
|
|
Overall Study
COMPLETED
|
157
|
151
|
|
Overall Study
NOT COMPLETED
|
31
|
40
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility
Baseline characteristics by cohort
| Measure |
Intensive Lifestyle Mod. Intervention
n=188 Participants
The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.
Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.
Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
Standard Lifestyle Intervention
n=191 Participants
Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
Total
n=379 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
n=5 Participants
|
32 years
n=7 Participants
|
32 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
188 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
379 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
179 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
356 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
45 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
126 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At time of birth, approximately 17 months into the studyDefined as a live birth of an infant born at ≥ 37 weeks, with a birth weight between 2500 and 4000g and without a major congenital anomaly
Outcome measures
| Measure |
Intensive Lifestyle Mod. Intervention
n=188 Participants
The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.
Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.
Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
Standard Lifestyle Intervention
n=191 Participants
Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
|---|---|---|
|
Rate of Good Birth Outcomes
|
23 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: At time of birth, approximately 17 months into the studyAll the live birth for the study
Outcome measures
| Measure |
Intensive Lifestyle Mod. Intervention
n=188 Participants
The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.
Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.
Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
Standard Lifestyle Intervention
n=191 Participants
Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
|---|---|---|
|
Live Birth Rate
|
38 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 0-8 monthsPopulation: For those who achieved pregnancy
Days from randomization to the first known date of conception
Outcome measures
| Measure |
Intensive Lifestyle Mod. Intervention
n=59 Participants
The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.
Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.
Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
Standard Lifestyle Intervention
n=52 Participants
Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
|---|---|---|
|
Time to Pregnancy in Days
|
160 days
Interval 102.0 to 190.0
|
163 days
Interval 98.5 to 214.0
|
SECONDARY outcome
Timeframe: After conception, 0-13 months into the studyPopulation: For those who achieved pregnancy
Pregnancy loss (conception without a live birth) among those who achieved pregnancy
Outcome measures
| Measure |
Intensive Lifestyle Mod. Intervention
n=63 Participants
The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.
Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.
Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
Standard Lifestyle Intervention
n=59 Participants
Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
|---|---|---|
|
Pregnancy Loss Rate
|
24 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: After conception, 1-13 months into the studyPopulation: For those with clinical pregnancy
Determined by number of multiple pregnancies / number of pregnancies
Outcome measures
| Measure |
Intensive Lifestyle Mod. Intervention
n=48 Participants
The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.
Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.
Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
Standard Lifestyle Intervention
n=45 Participants
Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
|---|---|---|
|
Multiple Pregnancy Rate
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: at time of birth, approximately 17 months into the studyPopulation: For the live-born infants
Birth weight (grams) for infant delivered
Outcome measures
| Measure |
Intensive Lifestyle Mod. Intervention
n=36 Participants
The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.
Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.
Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
Standard Lifestyle Intervention
n=42 Participants
Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
|---|---|---|
|
Birth Weight in Grams
|
3217.7 gram
Interval 2802.4 to 3642.9
|
3189.3 gram
Interval 2636.5 to 3671.3
|
SECONDARY outcome
Timeframe: At time of birth, approximately 17 months into the studyPopulation: For those who delivered baby(babies)
Babies by Cesarean Section/Number of participants who delivered baby
Outcome measures
| Measure |
Intensive Lifestyle Mod. Intervention
n=36 Participants
The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.
Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.
Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
Standard Lifestyle Intervention
n=40 Participants
Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
|---|---|---|
|
Mode of Delivery-Cesarean Section
|
19 Participants
|
23 Participants
|
Adverse Events
Intensive Lifestyle Mod. Intervention
Serious events: 12 serious events
Other events: 157 other events
Deaths: 0 deaths
Standard Lifestyle Intervention
Serious events: 13 serious events
Other events: 157 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intensive Lifestyle Mod. Intervention
n=188 participants at risk
The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.
Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.
Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
Standard Lifestyle Intervention
n=191 participants at risk
Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
|---|---|---|
|
Endocrine disorders
Hospitalization
|
1.1%
2/188 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
0.00%
0/191 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Endocrine disorders
Pelvic pain
|
0.53%
1/188 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
0.00%
0/191 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
General disorders
Appendicitis
|
0.00%
0/188 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
0.52%
1/191 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/188 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
0.52%
1/191 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
General disorders
Complex cyst resulting in surgical intervention
|
0.00%
0/188 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
0.52%
1/191 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Hospitalization during first trimester
|
1.6%
1/63 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
0.00%
0/59 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
1.6%
1/63 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
3.4%
2/59 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy of Unknown Location
|
4.8%
3/63 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
5.1%
3/59 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Marginal Placenta Previa
|
1.6%
1/63 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
0.00%
0/59 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Placenta Previa and Pre-term birth
|
0.00%
0/63 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
1.7%
1/59 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
General disorders
Hospitalization
|
3.2%
2/63 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
1.7%
1/59 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Hospitalization-infant
|
2.6%
1/38 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
4.8%
2/42 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Myelomeningocele
|
2.6%
1/38 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
0.00%
0/42 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/188 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
0.52%
1/191 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
Other adverse events
| Measure |
Intensive Lifestyle Mod. Intervention
n=188 participants at risk
The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.
Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.
Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
Standard Lifestyle Intervention
n=191 participants at risk
Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.
Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
|
|---|---|---|
|
Cardiac disorders
Constipation
|
12.2%
23/188 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
3.7%
7/191 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
General disorders
Diarrhea
|
18.6%
35/188 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
4.7%
9/191 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
General disorders
Fever
|
2.7%
5/188 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
0.00%
0/191 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Gastrointestinal disorders
Flatulence
|
17.6%
33/188 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
1.0%
2/191 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
General disorders
Mood swings
|
1.1%
2/188 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
4.7%
9/191 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
General disorders
Nausea/vomiting
|
21.8%
41/188 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
12.6%
24/191 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Gastrointestinal disorders
Oily stools/discharge
|
22.9%
43/188 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
0.00%
0/191 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Pre-term labor
|
3.2%
2/63 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
10.2%
6/59 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia/Eclampsia
|
6.3%
4/63 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
11.9%
7/59 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Gestational Diabetes
|
9.5%
6/63 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
16.9%
10/59 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Incompetent cervix
|
3.2%
2/63 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
0.00%
0/59 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
3.2%
2/63 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
6.8%
4/59 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Placental abnormalities
|
7.9%
5/63 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
6.8%
4/59 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Post-partum Infection
|
0.00%
0/63 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
3.4%
2/59 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Post-partum hemorrhage
|
0.00%
0/63 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
1.7%
1/59 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Other complication
|
6.3%
4/63 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
5.1%
3/59 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Other post-partum complication(s)
|
4.8%
3/63 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
1.7%
1/59 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Intrauterine growth restriction
|
2.6%
1/38 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
9.5%
4/42 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Admission to NICU
|
18.4%
7/38 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
28.6%
12/42 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
General disorders
Abdominal pain
|
10.6%
20/188 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
6.3%
12/191 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
General disorders
Anxiety/irritability
|
5.9%
11/188 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
7.3%
14/191 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
General disorders
Back pain
|
6.9%
13/188 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
10.5%
20/191 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
12.2%
23/188 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
13.1%
25/191 • From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place