PreTerm Birth
Conditions
Brief summary
This study is a controlled trial which compares the effect of zinc, beta-carotene, and Vitamin D3 supplementation in pregnant women which has preterm birth. The measured outcome is zinc, vitamin A, and 25(OH)D level in serum and placenta, MyD88, TRIF, NFκB, and IL-1β levels in placenta.
Detailed description
The research will be held in Cipto Mangunkusumo General and Budi Kemuliaan Hospital. Each participant of each group will be given the medication of preterm birth hospital protocol, which includes nifedipine 4x10 mg as tocolytic agent, dexamethasone 2x6 mg intravenous for 2 days which aims to support lung maturation, and antibiotic. Then, the blood sample is obtained for zinc, vitamin A and 25(OH)D levels examination. Subjects will be divided into 2 groups which are group whose given the oral zinc 50 mg/day, oral beta-carotene 25,000 IU and oral vitamin D3 50,000 IU/week supplementation, and group who is not given the intervention. Each participant will be observed until delivery. After delivery, level of zinc, vitamin A, and 25(OH)D in serum and placenta will be measured, as well as level of MyD88, TRIF, NFκB, and IL-1β in placenta.
Interventions
DRUGZinc
included in intervention arm
DRUGNifedipine
included in intervention and control arm
DRUGBeta Carotene
included in intervention arm
DRUGVitamin D3
included in intervention arm
DRUGDexamethasone
included in intervention and control arm
Sponsors
Indonesia University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women who has preterm birth in 26-36 weeks gestational age
Exclusion criteria
* Multiple pregnancy * Drug allergy * Intra Uterine Growth Retardation (IUGR) is detected * Congenital malformation in fetus was found * Preterm Premature Rupture of Membrane (PPROM) * Maternal complication such as gestational hypertension, preeclampsia, gestational diabetes mellitus, heart disease, infection, and autoimmune disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Placenta vitamin A | 1 year | Placenta vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL) |
| Placenta zinc | 1 year | Placenta zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L) |
| Placenta IL-1B | 1 year | Placenta IL-1B will be measured by ELISA. The level will be compared between intervention and control group (pg/mL) |
| Serum zinc | 1 year | Serum zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L) |
| Placenta NFkB | 1 year | Placenta NFkB will be measured by immunochemistry. The level will be compared between intervention and control group (percentage) |
| Placenta 25(OH)D | 1 year | Placenta 25(OH)D will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL) |
| Serum 25(OH)D | 1 year | Serum 25(OH)D will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL) |
| placenta MyD88 | 1 year | Placenta MyD88 will be measured by immunochemistry. The level will be compared between intervention and control group (percentage) |
| placenta TRIF | 1 year | Placenta TRIF will be measured by immunochemistry. The level will be compared between intervention and control group (percentage) |
| Serum vitamin A | 1 year | Serum vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL) |
Outcome results
None listed