Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2016-06-30
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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hyperemesis gravidarum
hyperemesis gravidarum group consisting of 30 pregnant women between 7-20 weeks of gestation with diagnosed hyperemesis gravidarum.
No interventions assigned to this group
Control group
control group consisting of 30 health pregnant women between 7-20 weeks of gestation with excluded hyperemesis gravidarum.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* İn hyperemesis group; 5% weight loss with regard to pre-gestation vomiting more than 3 times 3-5 % weight loss with ketonuria.
Exclusion Criteria
* 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
18 Years
35 Years
FEMALE
Yes
Sponsors
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Kayseri Education and Research Hospital
OTHER_GOV
Responsible Party
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Erdem Sahin
Principal Investigator
Principal Investigators
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Erdem SAHİN
Role: STUDY_DIRECTOR
Kayseri Training and Research Hospital
Locations
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Kayseri Training and Research Hospital
Kayseri, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Role: primary
References
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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.
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.
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.
Practice Bulletin No. 153: Nausea and Vomiting of Pregnancy. Obstet Gynecol. 2015 Sep;126(3):e12-e24. doi: 10.1097/AOG.0000000000001048.
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.
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.
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.
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.
Other Identifiers
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2016/345
Identifier Type: -
Identifier Source: org_study_id
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