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Hyperemesis GravidarumNCT03127293

Hyperemesis Gravidarum and Osteoporosis

An observational study of Hyperemesis Gravidarum, run by Adana Numune Training and Research Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Hyperemesis Gravidarum
What is being tested?
DEXA
How many people
79 participants
Where
No sites listed yet
Study dates
1 Jan 2015to 15 Dec 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: primigravid singleton pregnant patients

Who may be able to join

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

Who cannot join

  • 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.

About this study

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.

Read the 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.

Being tested
DEXA
Medical subject headings
Hyperemesis Gravidarum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DEXADiagnostic test

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

Study groups in NCT03127293
Study groupRoleWhat they receive
Hyperemesis Gravidarum groupBlood samples (10 mL) were drawn at the time of DEXA scans in postpartum period
Receives: Diagnostic Test: DEXA
control groupBlood samples (10 mL) were drawn at the time of DEXA scans in postpartum period
Receives: Diagnostic Test: DEXA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: up to 5 minutes

Secondary outcomes (1)
  1. blood tests

    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).

    Measured: up to 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2017
  2. Study start1 Jan 2015
  3. Primary completion15 Dec 2015
  4. Study completion15 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03127293
Sponsor's protocol ID
2014/435
Status last verified
Apr 2017
First submitted
15 Apr 2017
Last updated
26 Apr 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: if needed.

Publications

  • 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.

    PubMed 29398518

Questions about this trial

What is this clinical trial studying?

An observational study of Hyperemesis Gravidarum, run by Adana Numune Training and Research Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

dual energy x-ray absorptiometry (DEXA) (time frame: up to 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03127293, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.

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