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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02963753
Other study ID # 2017/173
Secondary ID
Status Completed
Phase N/A
First received November 10, 2016
Last updated April 12, 2017
Start date January 2016
Est. completion date November 2016

Study information

Verified date April 2017
Source Kayseri Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hyperemesis gravidarum (HEG) is not only nausea and vomiting of pregnancy, but it is also a clinical syndrome including endocrine and metabolic complications. Recently, some investigators have been begun performing researches related to the development of gestational diabetes mellitus (GDM) in pregnant women with HEG because they think about those metabolic and endocrine complications of HEG.In the literature there are few studies assessing how HEG has effects on GDM or 75 gram oral glucose tolerance test (OGTT). So the investigators aim to evaluate the effects of HEG on 75 gram OGTT.


Description:

This retrospective controlled study conducted by Obstetrics and Gynecology clinics of Kayseri Training and Research Hospital.Pregnant women who delivered at the Kayseri Education and Training Hospital of Medicine, in Turkey, between January 2010 and September 2016 were identified.This study was carried out with two groups. The study group consisted of women hospitalized for Hyperemesis gravidarum (HEG) during first trimester of their pregnancy, whereas the control group included all other women who delivered in the same period.Screening for GDM was performed twice during pregnancy. The first screening was performed during the first trimester using the random plasma glucose test with a cutoff value of 109 mg/dl. Screening for GDM was performed for all women during their first prenatal visit, regardless of the presence or absence of hyperemesis-associated symptoms.The second screening was performed during the second trimester, between 24 and 27 weeks, using a 75-g oral glucose tolerance test (OGTT), after pregnant women with HEG got rid of hyperemesis. GDM was diagnosed on the basis of the universal criteria established by the International Association of Diabetes and Pregnancy Study Group: a plasma glucose level that met or exceeded the fasting cutoff value 92 mg/dl, the first-hour cutoff value 180 mg/dl, or the second-hour cutoff value 153mg/dl.

To be considered for diagnosis of pre-gestational diabetes mellitus, women had to meet at least one of the following criteria: the fasting plasma glucose test with a cutoff value of 126 mg/dl or the random plasma glucose test with a cutoff value of 200 mg/dl or the second-hour cutoff value 153mg/dl after 75 gram OGGT (American Diabetes Association) The delivery midwifery and medical records were retrospectively evaluated. All of the patient's body mass index (BMI,calculated as weight in kilograms divided by the square of height in meters), urine ketone levels and ages were recorded separately both in the initial exam and during performing 75 gram OGTT.


Recruitment information / eligibility

Status Completed
Enrollment 560
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- between 18 and 35 years-old singleton pregnancies and performed 75 gram OGTT

Exclusion Criteria:

- Other causes lead to nausea and vomiting in pregnancy such as gastroenteritis, gastroparesis, hepatitis, intestinal obstruction, peptic ulcer, appendicitis, pyelonephritis, urolithiasis, ovarian torsion, diabetes mellitus, hyperthyroidism, hyperparathyroidism, migraine.

- And also patients who have risks for GDM such as body mass index > 30, history of GDM in previous pregnancy and diabetes in the family were excluded.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kayseri Education and Research Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary To determine serum glucose levels in both groups during 75 gram oral glucose tolerance test screening 3 months
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