Maternal Hypoglycemia and Placental Pathology - Full Text View

Purpose

The purpose of this retrospective pilot study is to assess the association of maternal hypoglycemia during the one hour glucose tolerance test with decreased placental weight and identifiable placental pathology. We hypothesize that a decreased one hour glucose tolerance test is a risk factor for decreased placental weight, an increased fetal to placental weight ratio, and other identifiable placental pathology.

Condition
Maternal Hypoglycemia

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	Maternal Hypoglycemia During One Hour Glucose Tolerance Test as a Risk for Decreased Placental Weight and Placental Pathology

Resource links provided by NLM:

MedlinePlus related topics: Hypoglycemia

U.S. FDA Resources

Further study details as provided by Oklahoma State University Center for Health Sciences:

Estimated Enrollment:	350
Study Start Date:	December 2007
Study Completion Date:	July 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Women younger than 35, who delivered a term infant either by vaginal delivery or cesarean section at Tulsa Regional Medical Center between July 1, 2005 and July 31, 2007

Criteria

Inclusion Criteria:

women younger than 35, who delivered a term infant either by vaginal delivery or cesarean section at Tulsa Regional Medical Center between July 1, 2005 and July 31, 2007

Exclusion Criteria:

insufficient gestational dates, multiple gestation, hypothyroidism, hyperthyroidism, heart disease, tobacco use, drug use, history of or current gestational diabetes, history of IUGR, chromosomal abnormalities, congenital malformations, preexisting diabetes, any autoimmune disease, hypertensive disorders, abnormal maternal screen, pulmonary disease, previous gastric bypass, any disease process that results in decreased gastrointestinal absorption, HIV, intrauterine amniotic infection, history of placental abruption, thrombophilia, body mass index (BMI) greater than 40 or BMI less than 19.8

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614094

Locations

United States, Oklahoma
Oklahoma State University Center for Health Sciences
Tulsa, Oklahoma, United States, 74107

Sponsors and Collaborators

Oklahoma State University Center for Health Sciences

Investigators

Principal Investigator:

John M Beal, D.O.

Oklahoma State University Center for Health Sciences Dept of OB/Gyn

More Information

Publications:

Casey BM, Lucas MJ, Mcintire DD, Leveno KJ. Pregnancy outcomes in women with gestational diabetes compared with the general obstetric population. Obstet Gynecol. 1997 Dec;90(6):869-73.

Abell DA, Beischer NA. Evaluation of the three-hour oral glucose tolerance test in detection of significant hyperglycemia and hypoglycemia in pregnancy. Diabetes. 1975 Oct;24(10):874-80.

Sokol RJ, Kazzi GM, Kalhan SC, Pillay SK. Identifying the pregnancy at risk for intrauterine growth retardation: possible usefulness of the intravenous glucose tolerance test. Am J Obstet Gynecol. 1982 May 15;143(2):220-3.

Langer O, Damus K, Maiman M, Divon M, Levy J, Bauman W. A link between relative hypoglycemia-hypoinsulinemia during oral glucose tolerance tests and intrauterine growth retardation. Am J Obstet Gynecol. 1986 Oct;155(4):711-6.

Calfee EF, Rust OA, Bofill JA, Ross EL, Morrison JC. Maternal hypoglycemia: is it associated with adverse perinatal outcome? J Perinatol. 1999 Jul-Aug;19(5):379-82.

Weissman A, Solt I, Zloczower M, Jakobi P. Hypoglycemia during the 100-g oral glucose tolerance test: incidence and perinatal significance. Obstet Gynecol. 2005 Jun;105(6):1424-8.

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.

Responsible Party:	J. Martin Beal, Oklahoma State University Center for Health Sciences Dept. of OB/Gyn
ClinicalTrials.gov Identifier:	NCT00614094 History of Changes
Other Study ID Numbers:	2007043
Study First Received:	January 31, 2008
Last Updated:	July 8, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Oklahoma State University Center for Health Sciences:

placenta, hypoglycemia

Additional relevant MeSH terms:

Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 22, 2013