Bone Health in Hyperemesis Gravidarum

Hyperemesis Gravidarum Clinical Trial

Official title:

Urine N-telopeptide, Serum Vit D, Parathormone and Calcium Levels in Hyperemesis Gravidarum

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02862496
• Other study ID #: 2016/345
• Status: Recruiting
• Phase: N/A
• First received: July 21, 2016
• Last updated: August 7, 2016
• Start date: June 2016
• Est. completion date: October 2016

Study information

• Verified date: August 2016
• Source: Kayseri Education and Research Hospital
• Contact: Erdem SAHIN, Study Principal Investigator
• Phone: +905321688683
• Email: erdemsahin07[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperemesis Gravidarum

Locations

Country	Name	City	State
Turkey	Kayseri Training and Research Hospital	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Kayseri Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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

Outcome

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