Hyperemesis Gravidarum Clinical Trial
Official title:
Is Hyperemesis Gravidarum a Risk Factor for Osteoporosis ?
Hyperemesis Gravidarum (HG) is a common disorder for hospitalization in the first trimester of pregnancy and related to protracted vomiting and nausea. It can be accompanied by ketonuria, dehydration and weight loss. Our aim was to investigate osteoporosis in patients with HG. In our study, we investigated osteoporosis in a total of 79 patients (40 HG and 39 control) by means of dual energy x-ray absorptiometry (DEXA) measurements and laboratory parameters related to HG.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04785911 -
Use of the Modified PUQE Score on Admitted Cases of Hyperemesis Gravidarum (HG) to Guide Response to Treatment
|
||
Recruiting |
NCT02619188 -
Nutritional Markers in Normal and Hyperemesis Pregnancies
|
N/A | |
Completed |
NCT04719286 -
MinSafeStart - Decision Aid Tool for Better Treatment of Nausea and Vomiting During Pregnancy
|
N/A | |
Completed |
NCT02300155 -
Improving Multivitamin Supplementation to Pregnant Women
|
Phase 4 | |
Completed |
NCT05175079 -
Acupressure in Hyperemesis Gravidarum
|
N/A | |
Completed |
NCT05098067 -
Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy
|
Phase 2 | |
Completed |
NCT01836835 -
Pregnancy Specific Nausea Questionnaire (PUQE) Translated and Tested in Norwegian
|
N/A | |
Completed |
NCT03950167 -
Gallbladder Functions & Serum Cholecystokinin Levels in Women Diagnosed With Hyperemesis Gravidarum
|
||
Completed |
NCT02830321 -
The Association of Helicobacter Pylori in the Pathogenesis of Hyperemesis Gravidarum in Pregnant Women
|
N/A | |
Completed |
NCT02541682 -
Assessment of the Relationship Between Affective Temperament and the Severity of Nausea and Vomiting in Early Pregnancy
|
N/A | |
Terminated |
NCT03785691 -
Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum
|
Phase 2 | |
Completed |
NCT05446025 -
The Levels of the Orexin, Galanin and aMSH and CART in Patients With Hyperemesis Gravidarum
|
||
Recruiting |
NCT02862496 -
Bone Health in Hyperemesis Gravidarum
|
N/A | |
Completed |
NCT02163434 -
Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
|
Phase 2 | |
Terminated |
NCT05452174 -
Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP)
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06442813 -
Effects Of Emotional Freedom Technique and Hypermesis Gravidarum
|
N/A | |
Completed |
NCT06245811 -
Inflammation Markers in Hyperemesis Gravidarum
|
||
Recruiting |
NCT06266819 -
The Effect of Mint Flavored Chewing Gum on Hyperemesis Gravidarum Nausea Vomiting Severity, Coping With Stress and Anxiety Level in Pregnants With Hyperemesis Gravidarum
|
N/A | |
Completed |
NCT04828967 -
Use of Hypnosis in Hyperemesis Gravidarum
|
N/A | |
Completed |
NCT01559012 -
Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum
|
Phase 3 |