Is Hyperemesis Gravidarum a Risk Factor for Osteoporosis ?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 主要终点
- dual energy x-ray absorptiometry (DEXA)
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •diagnosed with hyperemesis gravidarum
- •treated with intravenous fluids in first trimester
- •primigravid singleton pregnant patients
排除标准
- •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.
结局指标
主要结局
dual energy x-ray absorptiometry (DEXA)
时间窗: 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).
次要结局
- blood tests(up to 5 minutes)
研究者
Gulsum Uysal
Medical doctor
Adana Numune Training and Research Hospital
