Hyperemesis Gravidarum and Osteoporosis
Is Hyperemesis Gravidarum a Risk Factor for Osteoporosis ?
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
In our study, investigators prospectively enrolled gestational-age matched 40 women with history of HG and 39 women with history of healthy pregnancy in postpartum period, in Kayseri Education and Research Hospital, a tertiary teaching hospital in Kayseri, Turkey between january and december 2015. Ethics approval for the study was obtained from Erciyes School of Medicine and written informed consent was acquired from all subjects.
A total of 40 primigravid singleton pregnant patients aged over 18 years diagnosed with hyperemesis gravidarum and treated with intravenous fluids in first trimester were included in our study as HG group. HG was defined and diagnosed according to the criteria such that the pregnant was admitted one or more times for antepartum hospitalization because of protracted vomiting and nausea accompanied by weight loss, disturbance of electrolyte balance, ketonuria, and dehydration. The first hospitalization had occurred before 20 completed weeks of gestation.
Patients in following conditions were excluded from our study:
- Patients with diagnostic confounders such as overt hyperthyroidism, stomach disease, cholelithiasis, or gastroenteritis
- Patients with chronic illness (e.g.Crohn's disease, colitis ulcerosa, chronic liver disease, diabetes, thyroid disfunction, hyperparathyroidism) and multigenerational pregnancies,
- Patients with history of thyroid surgery, calcium and/or hormone producing tumours, systemic lupus erythematodes,
- Patients with eating disorders,
- Patients with usage of steroids, antiepileptic drugs and/or low molecular weight heparin (long term medication known to affect bone metabolism) and also patients with history of steroid usage for fetal lung maturation.
- Patients with history of osteoporosis, bone fracture in young ages in family. The control group consisted of healthy pregnant women. All patients gave birth between 37-40 gestational weeks. History of supplement containing vitamin usage during pregnancy were noted and also the data regarding demographic variables including age, parity, gravida, abortions, vitamin usage in pregnancy and body mass index (BMI) were asked and recorded.
All patients were performed on a standard dual energy x-ray absorptiometry (DEXA, Hologic Discovery Wi S/N 80848) during early postpartum period ( frequently in two days after birth before discharge of patients) by a single technician. Results for bone area, bone mineral density (BMD), bone mineral content (BMC), T and Z scores for lumbar spine (anteroposterior projection at L1-L4) and right hip were recorded. The radiation dose for all of the scans for lumbar spine and right hip were 4.3 µSv, 4.9 µSv, respectively. According to the World Health Organization (WHO) classification system , T-score ≤-2.5 is classified as osteoporosis and T-score between -2.5 and -1 is classified as osteopenia. In deed, a bone mass reduction more than 2.5 standard deviations compared to young adults of the same gender in DEXA scan (T score) is said to be osteoporosis in WHO criteria . Z score is the number of standard deviations above or below the mean for the patient's age, sex, and ethnicity while T score is the number of standard deviations above or below the mean for healthy 30 year old adult of the same sex, and ethnicity .
Biochemical analysis Blood samples (10 mL) were drawn at the time of DEXA scans in postpartum period and collected into ethylenediaminetetraacetate (EDTA) containing sterile tubes and serum separator tubes (SSTs). Samples were centrifugated at 3000 rpm for 10 minutes at room temperature. Serum and plasma of samples were than separated and stored at -80 ºC until the assay. Serum phosphorus (P) and calcium (Ca) were measured by Ion selective electrode (ISE) and alkaline phosphatase (ALP) activity was measured by kinetic enzymatic method, with reagents of Beckman Coulter, on an auto-analyser (Olympus AU5400, Beckman Coulter, Inc., U.S.A.). Serum intact parathormone (iPTH) was analyzed by two-site immunoenzymatic method and 25-hydroxy D levels were analyzed by competitive immunoenzymatic method on UniCel DxI 800 Immunoassay System (Beckman Coulter, Inc., U.S.A.).
Statistical analysis:
The statistical analyses were performed using SPSS for Windows 13.0. Descriptive statistics of all variables were calculated. Some data have been reported as the mean±standard deviation and percentage where necessary. The t-test was performed to compare means between two groups for normally distributed data, and the Mann-Whitney U-test was used for the non-normally distributed data. The χ2-test was used to compare proportions among groups for categorical data. Values of P<0.05 was accepted as statistically significant.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- diagnosed with hyperemesis gravidarum
- treated with intravenous fluids in first trimester
- primigravid singleton pregnant patients
Exclusion Criteria:
- Patients with diagnostic confounders such as overt hyperthyroidism, stomach disease, cholelithiasis, or gastroenteritis
- Patients with chronic illness (e.g.Crohn's disease, colitis ulcerosa, chronic liver disease, diabetes, thyroid disfunction, hyperparathyroidism) and multigenerational pregnancies,
- Patients with history of thyroid surgery, calcium and/or hormone producing tumours, systemic lupus erythematodes,
- Patients with eating disorders,
- Patients with usage of steroids, antiepileptic drugs and/or low molecular weight heparin (long term medication known to affect bone metabolism) and also patients with history of steroid usage for fetal lung maturation.
- Patients with history of osteoporosis, bone fracture in young ages in family.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Hyperemesis Gravidarum group
Blood samples (10 mL) were drawn at the time of DEXA scans in postpartum period
|
Blood samples (10 mL) were drawn at the time of DEXA scans in postpartum period
|
|
control group
Blood samples (10 mL) were drawn at the time of DEXA scans in postpartum period
|
Blood samples (10 mL) were drawn at the time of DEXA scans in postpartum period
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
dual energy x-ray absorptiometry (DEXA)
Time Frame: up to 5 minutes
|
All patients were performed on a standard dual energy x-ray absorptiometry (DEXA, Hologic Discovery Wi S/N 80848) during early postpartum period ( frequently in two days after birth before discharge of patients) by a single technician to assess osteoporosis.
Blood samples include laboratory parameters associated with osteoporosis (Vitamin D, ALP, P, Ca and PTH).
|
up to 5 minutes
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
blood tests
Time Frame: up to 5 minutes
|
Blood samples (10 mL) were drawn at the time of DEXA scans in postpartum period and collected into ethylenediaminetetraacetate (EDTA) containing sterile tubes and serum separator tubes (SSTs) to assess osteoporosis.
Blood samples include laboratory parameters associated with osteoporosis (Vitamin D, ALP, P, Ca and PTH).
|
up to 5 minutes
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Gulsum Uysal, Adana Numune Training and Research Hospital, Adana, Turkey
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2014/435
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hyperemesis Gravidarum
-
NCT02989337UnknownHyperemesis; Gravidarum, With Dehydration
-
NCT03785691TerminatedHyperemesis Gravidarum | Nausea Gravidarum | Vomiting of Pregnancy
-
NCT05244460RecruitingCannabis Hyperemesis Syndrome
-
NCT06772974Not yet recruitingHyperemesis Gravidarum | Nausea Gravidarum
-
NCT02963753CompletedGestational Diabetes | Hyperemesis; Gravidarum, With Dehydration
-
NCT04785911Completed
-
NCT01836835CompletedHyperemesis Gravidarum
Clinical Trials on DEXA
-
NCT02891356CompletedAnorexia Nervosa | Osteoporosis
-
NCT06092775Not yet recruiting
-
NCT06069089Not yet recruitingEvaluate Bone Denisty Changes in Children With Beta Thalassemia Major
-
NCT01019122CompletedCerebral Palsy | Bone Density
-
NCT06600334Not yet recruiting
-
NCT02523209CompletedChronic Kidney Diseases | Hyperparathyroidism, Secondary
-
NCT05883436RecruitingDegenerative Disc Disease