Bone Health in Hyperemesis Gravidarum

Sponsor

Kayseri Education and Research Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02862496

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Hyperemesis Gravidarum

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Urine N-telopeptide, Serum Vit D, Parathormone and Calcium Levels in Hyperemesis Gravidarum

Study Start Date :

Jun 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2016

Anticipated Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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