Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, 64460, Mexico
NCT Number: NCT04144595
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.
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Observational
Monterrey, Nuevo León, 64460, Mexico
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In pregnant women between 24 and 34 weeks of gestational age, plasma glucose was recorded after an overnight fast. Following consumption of 75 g glucose in 200 mL water over 10 min, the equivalent 1 hour and 2 hour values was recorded
Time frame: Newborn birth weight delivered on or after 25 week gestation will be recorded within the first hour after delivery
Birth weight <10th percentile according to the INTERGROWTH-21st newborn weight standards for gestational age/sex.
Time frame: Newborn birth weight delivered on or after 25 week gestation will be recorded within the first hour after delivery
Birthweight <3th percentile according to the INTERGROWTH-21st newborn weight standards for gestational age/sex.
Time frame: Newborn birth weight delivered on or after 37 week gestation will be recorded within the first hour after delivery
Birth weight <2500 g of newborn delivered on or after 37 week gestation
Hospital Universitario Dr. Jose E. Gonzalez
Other
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