Preeclampsia, Pregnant Women
Conditions
Keywords
antioxidant supplementation, preeclampsia
Brief summary
The purpose of this study is to investigate the benefit of several micro nutrients of antioxidants (using milk) in a cohort of women with low antioxidant status and the changes in cell-free mRNA.
Detailed description
Preeclampsia remains one of leading causes of maternal and perinatal mortality and morbidity. Despite intensive research, the cause of preeclampsia has not been established. One of the theories is exaggeration of systemic inflammatory that might induce reactive oxygen species (ROS). It has been proposed that pregnancy will progress uneventfully if adequate antioxidant exists to buffer ROS. The ROS can induce endothelial dysfunction which leads to clinical symptoms of hypertension and proteinuria in preeclampsia. Several large randomized clinical trials of antioxidant supplementation have concluded that there were no benefits of antioxidants supplementation for prevention of preeclampsia. However, there is limited information about benefits of antioxidants in women with low antioxidant status at early gestation that deprived of the antioxidant most. Our aim, therefore, in this study was to assess whether early supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium lowers the risk of preeclampsia in women with low antioxidant status at early gestation.
Interventions
DIETARY_SUPPLEMENTmicronutrient antioxidant
Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
DIETARY_SUPPLEMENTControl
supplementation with milk
Sponsors
Indonesia University
Showa University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* pregnant women with 8-12 weeks of gestation
Exclusion criteria
* known multiple pregnancy * known fetal anomaly * known thrombophilia * known infections and mola hydatidosa * chronic renal failure * uncontrolled hypertension * known placental abnormalities * documented uterine bleeding within a week of screening * uterine malformation * history of medical and metabolic complication such as heart disease or diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preeclampsia | 40 weeks | Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg \[Korotkoff V\] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (\> 0.3 g/day). Severe preeclampsia was defined by the presence of \>1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cell-free mRNA | 40 weeks | Secondary outcome were level of mRNA level of angiogenic factors (vascular endothelial growth factor receptor-1 (VEGFR-1), placental growth factor (PlGF) and endoglin(ENG)); antioxidant status (FRAP, heme oksigenase-1 (HO-1) and superoxide-dismutase (SOD)) |
Countries
Indonesia
Participant flow
Recruitment details
Recruitment started in June 2001 and completed in December 2009, Department of Obstetrics and Gynaecology, University of Indonesia, at Cipto Mangunkusumo National Hospital
Pre-assignment details
There were 110 (65.4 percent) eligible subjects from 168 pregnant women, because of ferric reducing ability of plasma (FRAP) level measured
Participants by arm
| Arm | Count |
|---|---|
| Micronutrient Antioxidant Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium | 52 |
| Control | 58 |
| Total | 110 |
Baseline characteristics
| Characteristic | Control | Micronutrient Antioxidant | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 52 Participants | 110 Participants |
| Age Continuous | 29.7 years STANDARD_DEVIATION 5.07 | 28.1 years STANDARD_DEVIATION 5.08 | 28.9 years STANDARD_DEVIATION 5.1 |
| Region of Enrollment Indonesia | 58 participants | 52 participants | 110 participants |
| Sex: Female, Male Female | 58 Participants | 52 Participants | 110 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Preeclampsia
Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg \[Korotkoff V\] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (\> 0.3 g/day). Severe preeclampsia was defined by the presence of \>1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)
Time frame: 40 weeks
Primary
Preeclampsia
Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg \[Korotkoff V\] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (\> 0.3 g/day). Severe preeclampsia was defined by the presence of \>1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Micronutrient Antioxidant | Preeclampsia | 1 participants |
| Control | Preeclampsia | 8 participants |
Secondary
Cell-free mRNA
Secondary outcome were level of mRNA level of angiogenic factors (vascular endothelial growth factor receptor-1 (VEGFR-1), placental growth factor (PlGF) and endoglin(ENG)); antioxidant status (FRAP, heme oksigenase-1 (HO-1) and superoxide-dismutase (SOD))
Time frame: 40 weeks