Bone Health in Hyperemesis Gravidarum

NCT02862496 | Unknown

• 1 other identifier: 2016/345
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperemesis Gravidarum

Keywords

Hyperemesis Gravidarum; Bone Health; Urine N-telopeptide; Serum calcium; Serum parathormone; Serum vit D

Outcome Measures

Primary Outcomes (4)

• Urine N- telopeptide levels in Pregnant Women with Hyperemesis Gravidarum

  4 months

• Serum Vitamin D Levels in Pregnant Women with Hyperemesis Gravidarum

  4 months

• Serum Calcium Levels in Pregnant Women with Hyperemesis Gravidarum

  4 months

• Serum Parathormone Levels in Pregnant Women with Hyperemesis Gravidarum

  4 months

Study Arms (2)

hyperemesis gravidarum

hyperemesis gravidarum group consisting of 30 pregnant women between 7-20 weeks of gestation with diagnosed hyperemesis gravidarum.

Control group

control group consisting of 30 health pregnant women between 7-20 weeks of gestation with excluded hyperemesis gravidarum.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kayseri Education and Research Hospital: lead

Study Sites (1)

Kayseri Training and Research Hospital

Kayseri, 38000, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• 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.

  PMID: 16150279 BACKGROUND

• 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.

  PMID: 18931500 BACKGROUND

• 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.

  PMID: 26004883 BACKGROUND

• Practice Bulletin No. 153: Nausea and Vomiting of Pregnancy. Obstet Gynecol. 2015 Sep;126(3):e12-e24. doi: 10.1097/AOG.0000000000001048.

  PMID: 26287788 BACKGROUND

• 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.

  PMID: 1466251 BACKGROUND

• 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.

  PMID: 24399365 BACKGROUND

• 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.

  PMID: 25209679 BACKGROUND

• 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.

  PMID: 30572827 DERIVED

MeSH Terms

Conditions

Hyperemesis Gravidarum

Condition Hierarchy (Ancestors)

Morning Sickness; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erdem SAHİN

  Kayseri Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Erdem SAHİN, Study Principal İnvestigator

CONTACT

+905321688683; erdemsahin07@hotmail.com

Yusuf MADENDAG

CONTACT

+905055011340; yusufmadendag@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: August 11, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

TU (1)