Clinical trial NCT02862496: Bone Health in Hyperemesis Gravidarum
Official title: Urine N-telopeptide, Serum Vit D, Parathormone and Calcium Levels in Hyperemesis Gravidarum
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperemesis Gravidarum
Keywords: Hyperemesis Gravidarum
Bone Health
Urine N-telopeptide
Serum calcium
Serum parathormone
Serum vit D
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2016-08-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population was consisted of 2 groups and included pregnant women in between 7. and 20. weeks of gestation for both groups. The normal pregnancy group was consisted of 30 healthy pregnant women whom excluded hyperemesis gravidarum (HG), the HG group was consisted of 30 pregnant women with diagnosed HG.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Between 7. and 20. weeks of gestation pregnant women in both groups
* İn 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

Primary outcomes:
measure: Urine N- telopeptide levels in Pregnant Women with Hyperemesis Gravidarum
timeFrame: 4 months
measure: Serum Vitamin D Levels in Pregnant Women with Hyperemesis Gravidarum
timeFrame: 4 months
measure: Serum Calcium Levels in Pregnant Women with Hyperemesis Gravidarum
timeFrame: 4 months
measure: Serum Parathormone Levels in Pregnant Women with Hyperemesis Gravidarum
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Kayseri Training and Research Hospital
Study officials:
affiliation: Kayseri Training and Research Hospital
name: Erdem SAHİN
role: STUDY_DIRECTOR
References:
citation: Bailit JL. Hyperemesis gravidarium: Epidemiologic findings from a large cohort. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 1):811-4. doi: 10.1016/j.ajog.2005.02.132.
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.
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. No abstract available.
citation: Practice Bulletin No. 153: Nausea and Vomiting of Pregnancy. Obstet Gynecol. 2015 Sep;126(3):e12-e24. doi: 10.1097/AOG.0000000000001048.
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. doi: 10.1002/jbmr.5650071119.
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.
citation: Sanz-Salvador L, Garcia-Perez MA, Tarin 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.
citation: Sahin E, Madendag Y, Eraslan Sahin M, Tayyar AT, Col Madendag I, Gozukucuk M, Karakukcu C, Acmaz G, Muderris II. Maternal type 1collagen N-terminal telopeptide levels in severe hyperemesis gravidarum. BMC Pregnancy Childbirth. 2018 Dec 20;18(1):502. doi: 10.1186/s12884-018-2149-7.