NCT03127293

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

12 months

First QC Date

April 15, 2017

Last Update Submit

April 24, 2017

Conditions

Hyperemesis Gravidarum

Outcome Measures

Primary Outcomes (1)

  • dual energy x-ray absorptiometry (DEXA)

    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 Outcomes (1)

  • blood tests

    up to 5 minutes

Study Arms (2)

Hyperemesis Gravidarum group

Blood samples (10 mL) were drawn at the time of DEXA scans in postpartum period

Diagnostic Test: DEXA

control group

Blood samples (10 mL) were drawn at the time of DEXA scans in postpartum period

Diagnostic Test: DEXA

Interventions

DEXADIAGNOSTIC_TEST

Blood samples (10 mL) were drawn at the time of DEXA scans in postpartum period

Hyperemesis Gravidarum groupcontrol group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

primigravid singleton pregnant patients

You may qualify if:

  • diagnosed with hyperemesis gravidarum
  • treated with intravenous fluids in first trimester
  • primigravid singleton pregnant patients

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Uysal G, Cagli F, Akkaya H, Nazik H, Karakukcu C, Sutbeyaz S, Yilmaz ES. Hyperemesis gravidarum is not a negative contributing factor for postpartum bone mineral density. J Chin Med Assoc. 2018 Jul;81(7):619-622. doi: 10.1016/j.jcma.2017.10.010. Epub 2018 Feb 3.

    PMID: 29398518DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma of samples were than seperated 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-hidroxy D levels were analyzed by competetive immunoenzymatic method on UniCel DxI 800 Immunoassay System (Beckman Coulter, Inc., U.S.A.).

MeSH Terms

Conditions

Hyperemesis Gravidarum

Condition Hierarchy (Ancestors)

Morning SicknessPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVomitingSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gulsum Uysal

    Adana Numune Training and Research Hospital, Adana, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

April 15, 2017

First Posted

April 25, 2017

Study Start

January 1, 2015

Primary Completion

December 15, 2015

Study Completion

December 15, 2015

Last Updated

April 26, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

if needed.