Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT04144595
Brief Summary:
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.
Detailed Description:
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
Study:
NCT04144595
Study Brief:
Protocol Section:
NCT04144595