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Bone Health in Hyperemesis Gravidarum

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ClinicalTrials.gov Identifier: NCT02862496
Recruitment Status : Unknown
Verified August 2016 by Erdem Sahin, Kayseri Education and Research Hospital.
Recruitment status was:  Recruiting
First Posted : August 11, 2016
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Erdem Sahin, Kayseri Education and Research Hospital

Study Description
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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.

Condition or disease
Hyperemesis Gravidarum

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: Urine N-telopeptide, Serum Vit D, Parathormone and Calcium Levels in Hyperemesis Gravidarum
Study Start Date : June 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Urine N- telopeptide levels in Pregnant Women with Hyperemesis Gravidarum [ Time Frame: 4 months ]
  2. Serum Vitamin D Levels in Pregnant Women with Hyperemesis Gravidarum [ Time Frame: 4 months ]
  3. Serum Calcium Levels in Pregnant Women with Hyperemesis Gravidarum [ Time Frame: 4 months ]
  4. Serum Parathormone Levels in Pregnant Women with Hyperemesis Gravidarum [ Time Frame: 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862496


Contacts
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Contact: Erdem SAHİN, Study Principal İnvestigator +905321688683 erdemsahin07@hotmail.com
Contact: Yusuf MADENDAG +905055011340 yusufmadendag@gmail.com

Locations
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Turkey
Kayseri Training and Research Hospital Recruiting
Kayseri, Turkey, 38000
Contact    5321688683    erdemsahin07@hotmail.com   
Sponsors and Collaborators
Kayseri Education and Research Hospital
Investigators
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Study Director: Erdem SAHİN Kayseri Training and Research Hospital
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Erdem Sahin, Principal Investigator, Kayseri Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02862496    
Other Study ID Numbers: 2016/345
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Keywords provided by Erdem Sahin, Kayseri Education and Research Hospital:
Hyperemesis Gravidarum
Bone Health
Urine N-telopeptide
 Serum calcium
Serum parathormone
Serum vit D
Additional relevant MeSH terms:
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Hyperemesis Gravidarum
Morning Sickness
Pregnancy Complications
Vomiting
Signs and Symptoms, Digestive