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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02862496
Other study ID # 2016/345
Secondary ID
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


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
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