Low Birth Weight Clinical Trial
Official title:
Association Between Low Plasma Glucose After Oral Glucose Tolerance Test in Pregnancy With Impaired Fetal Growth
Verified date | January 2020 |
Source | Hospital Universitario Dr. Jose E. Gonzalez |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | November 30, 2019 |
Est. primary completion date | October 28, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Universitario Dr. José Eleuterio González | Monterrey | Nuevo León |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario Dr. Jose E. Gonzalez |
Mexico,
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. — View Citation
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. — View Citation
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 — View Citation
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.i5.3 — View Citation
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. — View Citation
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. d — View Citation
Topçu HO, Iskender CT, Çelen 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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