NCT02963753

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

10 months

First QC Date

November 10, 2016

Last Update Submit

April 12, 2017

Conditions

Keywords

Hyperemesis gravidarumgestational diabetes mellitusoral glucose tolerance test

Outcome Measures

Primary Outcomes (1)

  • To determine serum glucose levels in both groups during 75 gram oral glucose tolerance test screening

    3 months

Study Arms (2)

hyperemesis gravidarum group

The study group consisted of women hospitalized for hyperemesis during first trimester of their pregnancy

the control group

whereas the control group included all other women who delivered in the same period.

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study was carried out with two groups. The study group consisted of women hospitalized for HEG during first trimester of their pregnancy, whereas the control group included all other women who delivered in the same period. When the pregnant women had those symptoms such as the presence of intractable vomiting during pregnancy associated with dehydration, electrolyte,and/or metabolic disturbances, as well as a weight loss 5% or more, they were diagnosed as HEG.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperemesis GravidarumDiabetes, Gestational

Condition Hierarchy (Ancestors)

Morning SicknessPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVomitingSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • YUSUF MADENDAG

    Kayseri Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 15, 2016

Study Start

January 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

April 13, 2017

Record last verified: 2017-04