Clinical Trial: Hyperemesis Gravidarum and Osteoporosis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Is Hyperemesis Gravidarum a Risk Factor for Osteoporosis ?

Brief Summary: 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.

Detailed Summary:

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 bo
    Sponsor: Adana Numune Training and Research Hospital

    Current Primary Outcome: 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).


    Original Primary Outcome: Same as current

    Current Secondary Outcome: 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).


    Original Secondary Outcome: Same as current

    Information By: Adana Numune Training and Research Hospital

    Dates:
    Date Received: April 15, 2017
    Date Started: January 1, 2015
    Date Completion:
    Last Updated: April 24, 2017
    Last Verified: April 2017