Association Between Low Plasma Glucose After Oral Glucose Tolerance Test

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04144595
Study type	Observational
Source	Hospital Universitario Dr. Jose E. Gonzalez
Contact
Status	Completed
Phase
Start date	January 1, 2019
Completion date	November 30, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Association Between Low Plasma Glucose After Oral Glucose Tolerance Test in Pregnancy With Impaired Fetal Growth

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms