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

NCT04144595 | Completed DMC

• 1 other identifier: GI19-00006
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Glucose Tolerance Test; Low Birth Weight

Keywords

Glucose Tolerance Test; Low Birth Weight

Outcome Measures

Primary Outcomes (3)

• Birth weight <10th percentile

  Birth weight \<10th percentile according to the INTERGROWTH-21st newborn weight standards for gestational age/sex.

  Newborn birth weight delivered on or after 25 week gestation will be recorded within the first hour after delivery

• Birthweight <3th percentile

  Birthweight \<3th percentile according to the INTERGROWTH-21st newborn weight standards for gestational age/sex.

  Newborn birth weight delivered on or after 25 week gestation will be recorded within the first hour after delivery

• Birth weight <2500 g

  Birth weight \<2500 g of newborn delivered on or after 37 week gestation

  Newborn birth weight delivered on or after 37 week gestation will be recorded within the first hour after delivery

Study Arms (2)

Low plasma glucose

This group will be formed by women with low plasma glucose: fasting plasma glucose (\<10th percentile, \<65 mg/dL), 1 or 2-hour low plasma glucose results after OGTT.

Diagnostic Test: 2 hour 75 g Oral glucose tolerance test

Normal plasma glucose

This group will be formed by women with normal plasma glucose: fasting plasma glucose ( ≥10th percentile, ≥65 mg/dL but \< 92 mg/dL), 1 or 2-hour normal glucose (\< 180 mg/dL and 153 mg/dL, respectively) results after OGTT.

Diagnostic Test: 2 hour 75 g Oral glucose tolerance test

Interventions

2 hour 75 g Oral glucose tolerance test DIAGNOSTIC_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

Low plasma glucose; Normal plasma glucose

Eligibility Criteria

• Gender Eligibility Details: Pregnant women at 24-28 week gestation
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consisted of patients with singleton pregnancies who underwent OGTT at 24-34 weeks, had regular medical checkups throughout their entire pregnancy, had delivered on or after 25 week gestation and had fulfilled inclusion criteria. This study was 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.

You may qualify if:

• Women with singleton pregnancy who underwent OGTT at 24-34 weeks and had regular medical checkups throughout their entire pregnancy.
• Gestational age was determined based on the last menstrual period. If gestational age according to the last menstrual period differed by more than 7 days from that according to ultrasonography at \<11 weeks, the latter was used to assign gestational age.

You may not qualify if:

• Inaccurate gestational age
• OGTT being drawn outside the prescribed window of 24 to 34 weeks gestation.
• Patients who could not swallow the OGTT solution or vomited afterward were excluded from the study.
• Patients who were diagnosed with gestational diabetes at any time during their pregnancy were excluded.
• The following comorbidities or complications that could affect fetal growth also were excluded: cardiac disease, preeclampsia, gestational hypertension, tobacco use, alcohol intake, stimulant drugs use, maternal systemic diseases (e.g., hypertension, pregestational diabetes, autoimmune disease, thrombotic disease, thyroid disease), intrauterine infectious diseases (e.g., cytomegalovirus, rubella, toxoplasmosis, syphilis), major neonatal anomalies or genetic and structural disorders (e.g., trisomy 21, trisomy 18, trisomy 13, congenital heart disease), placental disorders, and umbilical cord abnormalities.
• Patients with high risk for preeclampsia, intrauterine growth restriction, trisomy 21, trisomy 18 and trisomy 13 in the first trimester screening test.
• Patients with incomplete or missing data were also excluded.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (9)

• Nayak AU, Vijay AMA, Indusekhar R, Kalidindi S, Katreddy VM, Varadhan L. Association of hypoglycaemia in screening oral glucose tolerance test in pregnancy with low birth weight fetus. World J Diabetes. 2019 May 15;10(5):304-310. doi: 10.4239/wjd.v10.i5.304.

  PMID: 31139317 RESULT

• Shinohara S, Uchida Y, Hirai M, Hirata S, Suzuki K. Relationship between maternal hypoglycaemia and small-for-gestational-age infants according to maternal weight status: a retrospective cohort study in two hospitals. BMJ Open. 2016 Dec 2;6(12):e013749. doi: 10.1136/bmjopen-2016-013749.

  PMID: 27913562 RESULT

• Topcu HO, Iskender CT, Celen S, Oskovi A, Uygur D, Erkaya S. Maternal hypoglycemia on 50 g glucose challenge test: outcomes are influenced by fetal gender. J Perinat Med. 2016 May 1;44(4):369-76. doi: 10.1515/jpm-2015-0060.

  PMID: 25918915 RESULT

• Rogne T, Jacobsen GW. Association between low blood glucose increase during glucose tolerance tests in pregnancy and impaired fetal growth. Acta Obstet Gynecol Scand. 2014 Nov;93(11):1160-9. doi: 10.1111/aogs.12365. Epub 2014 Mar 26.

  PMID: 24576054 RESULT

• Melamed N, Hiersch L, Peled Y, Hod M, Wiznitzer A, Yogev Y. The association between low 50 g glucose challenge test result and fetal growth restriction. J Matern Fetal Neonatal Med. 2013 Jul;26(11):1107-11. doi: 10.3109/14767058.2013.770460. Epub 2013 Feb 27.

  PMID: 23350735 RESULT

• Vadakekut ES, McCoy SJ, Payton ME. Association of maternal hypoglycemia with low birth weight and low placental weight: a retrospective investigation. J Am Osteopath Assoc. 2011 Mar;111(3):148-52.

  PMID: 21464263 RESULT

• Feinberg JH, Magann EF, Morrison JC, Holman JR, Polizzotto MJ. Does maternal hypoglycemia during screening glucose assessment identify a pregnancy at-risk for adverse perinatal outcome? J Perinatol. 2005 Aug;25(8):509-13. doi: 10.1038/sj.jp.7211336.

  PMID: 15908987 RESULT

• Leng J, Hay J, Liu G, Zhang J, Wang J, Liu H, Yang X, Liu J. Small-for-gestational age and its association with maternal blood glucose, body mass index and stature: a perinatal cohort study among Chinese women. BMJ Open. 2016 Sep 15;6(9):e010984. doi: 10.1136/bmjopen-2015-010984.

  PMID: 27633632 RESULT

• Hernandez-Castro F, Berlanga-Garza A, Cruz-Gutierrez MD, Soria-Lopez JA, Villagomez-Martinez GE, Davila-Escamilla IV. Prediction of low birth weight with hypoglycemia in glucose tolerance test. Rev Saude Publica. 2021 May 17;55:30. doi: 10.11606/s1518-8787.2021055002543. eCollection 2021.

  PMID: 34008784 DERIVED

MeSH Terms

Interventions

Glucose Tolerance Test

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Flavio Hernández Castro, MD PhD

  Obstetrics Department Universidad Autónoma de Nuevo León

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: January 1, 2019
• Primary Completion: October 28, 2019
• Study Completion: November 30, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)