NCT04144595

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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

Conditions

• Oral Glucose Tolerance Test
• Low Birth Weight

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	2 hour 75 g Oral glucose tolerance test	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

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-10-28
• Completion: 2019-11-30
• First posted: 2019-10-30
• Last updated: 2020-01-13

Locations

1 site across 1 country: Mexico