Trial Outcomes & Findings for Maternal Lifestyle and Neonatal Hypoglycemia (NCT NCT01409382)
NCT ID: NCT01409382
Last Updated: 2016-09-29
Results Overview
Any glucose level equal or below 40mg/dL at 1, 2 or 4 h after birth, obtained by heelstick.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
480 participants
Primary outcome timeframe
1, 2 and 4 h after birth.
Results posted on
2016-09-29
Participant Flow
Recruitment has started in March 2011 at a High-Risk Maternal and Fetal Unit of a tertiary hospital. Enrollment started in May 2011.
Participant milestones
| Measure |
Lifestyle Counseling
Daily brisk walking plus a carbohydrate-restricted diet. Patients assigned to the intervention protocol will be instructed to walk briskly for at least 40 minutes seven days a week, to avoid high-carbohydrate meals (such as snacks, candies, fiber-free juices and sugar-sweetened beverages), and to eat at least two daily servings of meat, poultry, fish (e.g. 2 g/kg) or other protein-rich food, starting when they decided to get pregnant and continuing until delivery. Antidepressants will be not discontinued, but patients on paroxetine and sertraline will be switched to fluoxetine.
|
Standard Follow-up
Prenatal care will proceed according to the routine. Antidepressants will be not discontinued, but patients on paroxetine and sertraline will be switched to fluoxetine.
|
|---|---|---|
|
Overall Study
STARTED
|
240
|
240
|
|
Overall Study
COMPLETED
|
159
|
160
|
|
Overall Study
NOT COMPLETED
|
81
|
80
|
Reasons for withdrawal
| Measure |
Lifestyle Counseling
Daily brisk walking plus a carbohydrate-restricted diet. Patients assigned to the intervention protocol will be instructed to walk briskly for at least 40 minutes seven days a week, to avoid high-carbohydrate meals (such as snacks, candies, fiber-free juices and sugar-sweetened beverages), and to eat at least two daily servings of meat, poultry, fish (e.g. 2 g/kg) or other protein-rich food, starting when they decided to get pregnant and continuing until delivery. Antidepressants will be not discontinued, but patients on paroxetine and sertraline will be switched to fluoxetine.
|
Standard Follow-up
Prenatal care will proceed according to the routine. Antidepressants will be not discontinued, but patients on paroxetine and sertraline will be switched to fluoxetine.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
3
|
|
Overall Study
Multiple pregnancy
|
2
|
4
|
|
Overall Study
Still pregnant when study ended
|
13
|
2
|
|
Overall Study
Did not manage to get pregnant
|
64
|
70
|
|
Overall Study
Had a 2nd trimester loss after accident
|
1
|
0
|
Baseline Characteristics
Maternal Lifestyle and Neonatal Hypoglycemia
Baseline characteristics by cohort
| Measure |
Lifestyle Counseling
n=240 Participants
Daily brisk walking plus a carbohydrate-restricted diet
|
Standard Follow-up
n=240 Participants
Prenatal care will proceed according to the routine
|
Total
n=480 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
240 Participants
n=5 Participants
|
240 Participants
n=7 Participants
|
480 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 6 • n=5 Participants
|
33 years
STANDARD_DEVIATION 8 • n=7 Participants
|
33 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
240 Participants
n=5 Participants
|
240 Participants
n=7 Participants
|
480 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
240 participants
n=5 Participants
|
240 participants
n=7 Participants
|
480 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1, 2 and 4 h after birth.Any glucose level equal or below 40mg/dL at 1, 2 or 4 h after birth, obtained by heelstick.
Outcome measures
| Measure |
Lifestyle Counseling
n=420 blood samples 1, 2 and 4 h after birth
Daily brisk walking plus a carbohydrate-restricted diet
|
Standard Follow-up
n=273 blood samples 1, 2 and 4 h after birth
Prenatal care will proceed according to the routine.
|
|---|---|---|
|
Neonatal Hypoglycemia
|
3 neonates
|
15 neonates
|
SECONDARY outcome
Timeframe: One hour after feeding or after intravenous dextrosePopulation: All hypoglycemic neonates were screened for refractory hypoglycemia. Only neonates born to mothers who were physically inactive and reported excessive carbohydrate consumption displayed refractory hypoglycemia.
Any glucose level ≤ 40/dL at 1, 2 or 4 h: 1. Neonates with hypoglycemia (glucose level equal or below 40 mg/dL at 1, 2 or 4 h) will be offered milk. Neonates unable to suckle, will be treated with intravenous dextrose for one hour. 2. A new heel stick blood sample will be drawn to assess glucose levels. 3. Neonates with persistent hypoglycemia will be considered as refractory hypoglycemia.
Outcome measures
| Measure |
Lifestyle Counseling
n=3 Participants
Daily brisk walking plus a carbohydrate-restricted diet
|
Standard Follow-up
n=15 Participants
Prenatal care will proceed according to the routine.
|
|---|---|---|
|
Refractory Hypoglycemia
|
0 neonates with refractory hypoglycemia
|
3 neonates with refractory hypoglycemia
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Three yearsEarly miscarriages, 2nd and 3rd trimester losses, preterm deliveries, take-home babies, neonatal hypoglycemia: number of babies
Outcome measures
| Measure |
Lifestyle Counseling
n=159 Participants
Daily brisk walking plus a carbohydrate-restricted diet
|
Standard Follow-up
n=160 Participants
Prenatal care will proceed according to the routine.
|
|---|---|---|
|
Pregnancy and Neonatal Outcomes
Early Miscarriages
|
19 participants (babies)
|
62 participants (babies)
|
|
Pregnancy and Neonatal Outcomes
Second and Third Trimester Losses
|
0 participants (babies)
|
7 participants (babies)
|
|
Pregnancy and Neonatal Outcomes
Live Born
|
140 participants (babies)
|
91 participants (babies)
|
|
Pregnancy and Neonatal Outcomes
Term
|
126 participants (babies)
|
57 participants (babies)
|
|
Pregnancy and Neonatal Outcomes
Take-home babies
|
140 participants (babies)
|
83 participants (babies)
|
|
Pregnancy and Neonatal Outcomes
Neonatal hypoglycemia
|
3 participants (babies)
|
15 participants (babies)
|
Adverse Events
Standard Follow-up (Mothers)
Serious events: 36 serious events
Other events: 0 other events
Deaths: 0 deaths
Lifestyle Counseling (Mothers)
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Follow-up (Babies)
Serious events: 84 serious events
Other events: 0 other events
Deaths: 0 deaths
Lifestyle Counseling (Babies)
Serious events: 22 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Follow-up (Mothers)
n=160 participants at risk
Prenatal care will proceed according to the routine.
|
Lifestyle Counseling (Mothers)
n=159 participants at risk
Exercise plus a carbohydrate-controlled diet.
|
Standard Follow-up (Babies)
n=160 participants at risk
Prenatal care will proceed according to the routine.
|
Lifestyle Counseling (Babies)
n=159 participants at risk
Exercise plus a carbohydrate-controlled diet.
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
First trimester
|
—
0/0 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
—
0/0 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
38.8%
62/160 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
11.9%
19/159 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
|
Pregnancy, puerperium and perinatal conditions
Second and third trimester
|
—
0/0 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
—
0/0 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
4.4%
7/160 • Number of events 7 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
0.00%
0/159 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
|
Endocrine disorders
Gestational diabetes mellitus
|
10.6%
17/160 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
1.9%
3/159 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
—
0/0 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
—
0/0 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
|
Pregnancy, puerperium and perinatal conditions
Preeclampsia
|
13.8%
22/160 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
5.0%
8/159 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
—
0/0 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
—
0/0 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
|
Pregnancy, puerperium and perinatal conditions
neonatal hypoglycemia
|
—
0/0 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
—
0/0 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
16.5%
15/91 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
2.1%
3/140 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
|
Pregnancy, puerperium and perinatal conditions
neonatal death
|
—
0/0 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
—
0/0 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
8.8%
8/91 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
0.00%
0/140 • From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Silvia Hoirisch-Clapauch
Hospital Federal dos Servidores do Estado
Phone: 55-21-999737500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place