Low Birth Weight Clinical Trial
Official title:
Association Between Low Plasma Glucose After Oral Glucose Tolerance Test in Pregnancy With Impaired Fetal Growth
Objective: To study the association of low maternal plasma glucose in 2 hour 75 g oral
glucose tolerance test (OGTT) in women with impaired birth weight and determinate if this
result is predictive of low birth weight (<10th percentile according to the INTERGROWTH-21st
newborn weight standards for gestational age/sex).
Materials and methods: OGTT at 24-34 week gestation will be performed in pregnant women, the
birth weight will be compared between women with low fasting plasma glucose (FPG) (<10th
percentile, <65 mg/dL) and normal FPG (≥10th percentile, ≥ 65 mg/dL) also for 1 and 2-hour
plasma glucose (1-h PG/2-h PG). Receiver operating characteristic curve analysis will be used
to determine the optimal lower OGTT threshold for the prediction of low birth weight.
Maternal hypoglycemia has been reported to be linked with low birth weight and poor neonatal
outcome. OGTT is performed routinely in pregnancy and hypoglycemia following this screening
test is often encountered and the implication of this finding for the fetal growth is
unclear.
The aim of study will be determinate the association of low maternal plasma glucose in OGTT
in women with impaired birth weight and determinate if this result is predictive of low birth
weight (<10th percentile according to the INTERGROWTH-21st newborn weight standards for
gestational age/sex).
The study population will consist of patients with singleton pregnancies who will undergo
OGTT at 24-34 weeks, have regular medical checkups throughout their entire pregnancy, deliver
on or after 25 week gestation and fulfill inclusion criteria.
The birth weight will be compared between women with low fasting plasma glucose (FPG) (<10th
percentile, <65 mg/dL*) and normal FPG (≥10th percentile, ≥ 65 mg/dL) also for 1 and 2-hour
plasma glucose (1-h PG/2-h PG). Receiver operating characteristic curve analysis will be used
to determine the optimal lower OGTT threshold for the prediction of low birth weight.
This study will be performed according to the standards of the Helsinki Declaration and
approval was obtained from the ethics and educational issues coordinating committee of our
University Hospital.
*Determinated previously in a pilot study
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