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Maternal Hypoglycemia and Placental Pathology

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00614094
First Posted: February 13, 2008
Last Update Posted: July 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oklahoma State University Center for Health Sciences
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: January 31, 2008
First Posted: February 13, 2008
Last Update Posted: July 9, 2008
Last Verified: July 2008

Keywords provided by Oklahoma State University Center for Health Sciences:
placenta, hypoglycemia

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases