Hyperemesis Gravidarum Clinical Trial
Official title:
Urine N-telopeptide, Serum Vit D, Parathormone and Calcium Levels in Hyperemesis Gravidarum
The purpose of the study is to determine whether maternal bone resorption would be seen in Hyperemesis Gravidarum and could be detected in early period using serum vitamin D levels, serum calcium (Ca) levels, serum parathormone (PTH) levels and urine N- telopeptide levels in the patients with Hyperemesis Gravidarum.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Between 7. and 20. weeks of gestation pregnant women in both groups - In hyperemesis group; 5% weight loss with regard to pre-gestation vomiting more than 3 times 3-5 % weight loss with ketonuria. Exclusion Criteria: - Other pathologies that cause nausea and vomiting in pregnancy gastroenteritis gastroparesis gall duct diseases hepatitis peptic ulcers appendicitis pyelonephritis ovarian torsion urinary tract stones diabetic ketoacidosis hyperthyroidism hyperparathyroidism migraine pseudo tumor cerebra vestibular diseases - Additionally some situations causing to rise of Ntx levels osteoporosis paget disease bone tumors - Furthermore some of conditions resulted in pre-menopausal osteoporosis or decreasing in Bone Mineral Density Malignancy Smoking Celiac Disease Depression Inflammatory Bowel Disease Pre-gestational Diabetes Chronic Kidney or Liver Disease Drug Use such as steroids, anticonvulsants, antiepileptic, heparin or low molecular weight heparin |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Turkey | Kayseri Training and Research Hospital | Kayseri |
Lead Sponsor | Collaborator |
---|---|
Kayseri Education and Research Hospital |
Turkey,
Bailit JL. Hyperemesis gravidarium: Epidemiologic findings from a large cohort. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 1):811-4. — View Citation
Hanson DA, Weis MA, Bollen AM, Maslan SL, Singer FR, Eyre DR. A specific immunoassay for monitoring human bone resorption: quantitation of type I collagen cross-linked N-telopeptides in urine. J Bone Miner Res. 1992 Nov;7(11):1251-8. — View Citation
Hlaing TT, Compston JE. Biochemical markers of bone turnover - uses and limitations. Ann Clin Biochem. 2014 Mar;51(Pt 2):189-202. doi: 10.1177/0004563213515190. Epub 2014 Jan 7. Review. — View Citation
Minami H, Furuhashi M, Minami K, Miyazaki K, Yoshida K, Ishikawa K. Fetal intraventricular bleeding possibly due to maternal vitamin K deficiency. Fetal Diagn Ther. 2008;24(4):357-60. doi: 10.1159/000163078. Epub 2008 Oct 16. — View Citation
Practice Bulletin No. 153: Nausea and Vomiting of Pregnancy. Obstet Gynecol. 2015 Sep;126(3):e12-24. doi: 10.1097/AOG.0000000000001048. Review. — View Citation
Sanz-Salvador L, García-Pérez MÁ, Tarín JJ, Cano A. Bone metabolic changes during pregnancy: a period of vulnerability to osteoporosis and fracture. Eur J Endocrinol. 2015 Feb;172(2):R53-65. doi: 10.1530/EJE-14-0424. Epub 2014 Sep 10. Review. — View Citation
Yahia M, Najeh H, Zied H, Khalaf M, Salah AM, Sofienne BM, Laidi B, Hamed J, Hayenne M. Wernicke's encephalopathy: A rare complication of hyperemesis gravidarum. Anaesth Crit Care Pain Med. 2015 Jun;34(3):173-7. doi: 10.1016/j.accpm.2014.09.005. Epub 2015 May 21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urine N- telopeptide levels in Pregnant Women with Hyperemesis Gravidarum | 4 months | No | |
Primary | Serum Vitamin D Levels in Pregnant Women with Hyperemesis Gravidarum | 4 months | No | |
Primary | Serum Calcium Levels in Pregnant Women with Hyperemesis Gravidarum | 4 months | No | |
Primary | Serum Parathormone Levels in Pregnant Women with Hyperemesis Gravidarum | 4 months | No |
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