Hyperemesis GravidarumNCT02862496
Bone Health in Hyperemesis Gravidarum
An observational study of Hyperemesis Gravidarum, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study is to determine whether maternal bone resorption would be seen in Hyperemesis Gravidarum and could be detected in early period using serum vitamin D levels, serum calcium (Ca) levels, serum parathormone (PTH) levels and urine N- telopeptide levels in the patients with Hyperemesis Gravidarum. 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
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2016to Oct 2016
- How long will I take part?
- 9 Months
- 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: The study population was consisted of 2 groups and included pregnant women in between 7. and 20. weeks of gestation for both groups. The normal pregnancy group was consisted of 30 healthy pregnant women whom excluded hyperemesis gravidarum (HG), the HG group was consisted of 30 pregnant women with diagnosed HG.
Who may be able to join
- Between 7. and 20. weeks of gestation pregnant women in both groups
- İn hyperemesis group; 5% weight loss with regard to pre-gestation vomiting more than 3 times 3-5 % weight loss with ketonuria.
Who cannot join
- Other pathologies that cause nausea and vomiting in pregnancy gastroenteritis gastroparesis gall duct diseases hepatitis peptic ulcers appendicitis pyelonephritis ovarian torsion urinary tract stones diabetic ketoacidosis hyperthyroidism hyperparathyroidism migraine pseudo tumor cerebra vestibular diseases
- Additionally some situations causing to rise of Ntx levels osteoporosis paget disease bone tumors
- Furthermore some of conditions resulted in pre-menopausal osteoporosis or decreasing in Bone Mineral Density Malignancy Smoking Celiac Disease Depression Inflammatory Bowel Disease Pre-gestational Diabetes Chronic Kidney or Liver Disease Drug Use such as steroids, anticonvulsants, antiepileptic, heparin or low molecular weight heparin
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kayseri Training and Research Hospital
Kayseri, 38000
5321688683, erdemsahin07@hotmail.com
About this study
Official title: Urine N-telopeptide, Serum Vit D, Parathormone and Calcium Levels in Hyperemesis Gravidarum
The purpose of the study is to determine whether maternal bone resorption would be seen in Hyperemesis Gravidarum and could be detected in early period using serum vitamin D levels, serum calcium (Ca) levels, serum parathormone (PTH) levels and urine N- telopeptide levels in the patients with Hyperemesis Gravidarum.
- Conditions
- Hyperemesis Gravidarum
- Keywords
- Hyperemesis Gravidarum, Bone Health, Urine N-telopeptide, Serum calcium, Serum parathormone, Serum vit D
- Medical subject headings
- Hyperemesis Gravidarum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hyperemesis gravidarum | hyperemesis gravidarum group consisting of 30 pregnant women between 7-20 weeks of gestation with diagnosed hyperemesis gravidarum. | |
| Control group | control group consisting of 30 health pregnant women between 7-20 weeks of gestation with excluded hyperemesis gravidarum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine N- telopeptide levels in Pregnant Women with Hyperemesis Gravidarum
Measured: 4 months
Serum Vitamin D Levels in Pregnant Women with Hyperemesis Gravidarum
Measured: 4 months
Serum Calcium Levels in Pregnant Women with Hyperemesis Gravidarum
Measured: 4 months
Serum Parathormone Levels in Pregnant Women with Hyperemesis Gravidarum
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hyperemesis GravidarumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 60 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erdem Sahin, Kayseri Education and Research Hospital
- Investigators
- Erdem SAHİN, Study director, Kayseri Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862496
- Sponsor's protocol ID
- 2016/345
- Status last verified
- Aug 2016
- First submitted
- 21 Jul 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
Publications
Bailit JL. Hyperemesis gravidarium: Epidemiologic findings from a large cohort. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 1):811-4. doi: 10.1016/j.ajog.2005.02.132.
PubMed 16150279Minami H, Furuhashi M, Minami K, Miyazaki K, Yoshida K, Ishikawa K. Fetal intraventricular bleeding possibly due to maternal vitamin K deficiency. Fetal Diagn Ther. 2008;24(4):357-60. doi: 10.1159/000163078. Epub 2008 Oct 16.
PubMed 18931500Yahia M, Najeh H, Zied H, Khalaf M, Salah AM, Sofienne BM, Laidi B, Hamed J, Hayenne M. Wernicke's encephalopathy: A rare complication of hyperemesis gravidarum. Anaesth Crit Care Pain Med. 2015 Jun;34(3):173-7. doi: 10.1016/j.accpm.2014.09.005. Epub 2015 May 21. No abstract available.
PubMed 26004883Practice Bulletin No. 153: Nausea and Vomiting of Pregnancy. Obstet Gynecol. 2015 Sep;126(3):e12-e24. doi: 10.1097/AOG.0000000000001048.
PubMed 26287788Hanson DA, Weis MA, Bollen AM, Maslan SL, Singer FR, Eyre DR. A specific immunoassay for monitoring human bone resorption: quantitation of type I collagen cross-linked N-telopeptides in urine. J Bone Miner Res. 1992 Nov;7(11):1251-8. doi: 10.1002/jbmr.5650071119.
PubMed 1466251Hlaing TT, Compston JE. Biochemical markers of bone turnover - uses and limitations. Ann Clin Biochem. 2014 Mar;51(Pt 2):189-202. doi: 10.1177/0004563213515190. Epub 2014 Jan 7.
PubMed 24399365Sanz-Salvador L, Garcia-Perez MA, Tarin JJ, Cano A. Bone metabolic changes during pregnancy: a period of vulnerability to osteoporosis and fracture. Eur J Endocrinol. 2015 Feb;172(2):R53-65. doi: 10.1530/EJE-14-0424. Epub 2014 Sep 10.
PubMed 25209679Sahin E, Madendag Y, Eraslan Sahin M, Tayyar AT, Col Madendag I, Gozukucuk M, Karakukcu C, Acmaz G, Muderris II. Maternal type 1collagen N-terminal telopeptide levels in severe hyperemesis gravidarum. BMC Pregnancy Childbirth. 2018 Dec 20;18(1):502. doi: 10.1186/s12884-018-2149-7.
PubMed 30572827
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine N-telopeptide, Serum Vit D, Parathormone and Calcium Levels in Hyperemesis Gravidarum
- ClinicalTrials.gov ID
- NCT02862496
- Acronym / sponsor ID
- 2016/345
- Conditions
- Hyperemesis Gravidarum
- Keywords
- Hyperemesis Gravidarum, Bone Health, Urine N-telopeptide, Serum calcium, Serum parathormone, Serum vit D
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- Jun 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether maternal bone resorption would be seen in Hyperemesis Gravidarum and could be detected in early period using serum vitamin D levels, serum calcium (Ca) levels, serum parathormone (PTH) levels and urine N- telopeptide levels in the patients with Hyperemesis Gravidarum.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperemesis gravidarum | – | –hyperemesis gravidarum group consisting of 30 pregnant women between 7-20 weeks of gestation with diagnosed hyperemesis gravidarum. |
| Control group | – | –control group consisting of 30 health pregnant women between 7-20 weeks of gestation with excluded hyperemesis gravidarum. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population was consisted of 2 groups and included pregnant women in between 7. and 20. weeks of gestation for both groups. The normal pregnancy group was consisted of 30 healthy pregnant women whom excluded hyperemesis gravidarum (HG), the HG group was consisted of 30 pregnant women with diagnosed HG.
Key inclusion criteria (2 listed)
- Between 7. and 20. weeks of gestation pregnant women in both groups
- İn hyperemesis group; 5% weight loss with regard to pre-gestation vomiting more than 3 times 3-5 % weight loss with ketonuria.
Key exclusion criteria (3 listed)
- Other pathologies that cause nausea and vomiting in pregnancy gastroenteritis gastroparesis gall duct diseases hepatitis peptic ulcers appendicitis pyelonephritis ovarian torsion urinary tract stones diabetic ketoacidosis hyperthyroidism hyperparathyroidism migraine pseudo tumor cerebra vestibular diseases
- Additionally some situations causing to rise of Ntx levels osteoporosis paget disease bone tumors
- Furthermore some of conditions resulted in pre-menopausal osteoporosis or decreasing in Bone Mineral Density Malignancy Smoking Celiac Disease Depression Inflammatory Bowel Disease Pre-gestational Diabetes Chronic Kidney or Liver Disease Drug Use such as steroids, anticonvulsants, antiepileptic, heparin or low molecular weight heparin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urine N- telopeptide levels in Pregnant Women with Hyperemesis Gravidarum
Time frame: 4 months
Serum Vitamin D Levels in Pregnant Women with Hyperemesis Gravidarum
Time frame: 4 months
Serum Calcium Levels in Pregnant Women with Hyperemesis Gravidarum
Time frame: 4 months
Serum Parathormone Levels in Pregnant Women with Hyperemesis Gravidarum
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Background: PubMed 16150279Bailit JL. Hyperemesis gravidarium: Epidemiologic findings from a large cohort. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 1):811-4. doi: 10.1016/j.ajog.2005.02.132.
- Background: PubMed 18931500Minami H, Furuhashi M, Minami K, Miyazaki K, Yoshida K, Ishikawa K. Fetal intraventricular bleeding possibly due to maternal vitamin K deficiency. Fetal Diagn Ther. 2008;24(4):357-60. doi: 10.1159/000163078. Epub 2008 Oct 16.
- Background: PubMed 26004883Yahia M, Najeh H, Zied H, Khalaf M, Salah AM, Sofienne BM, Laidi B, Hamed J, Hayenne M. Wernicke's encephalopathy: A rare complication of hyperemesis gravidarum. Anaesth Crit Care Pain Med. 2015 Jun;34(3):173-7. doi: 10.1016/j.accpm.2014.09.005. Epub 2015 May 21. No abstract available.
- Background: PubMed 26287788Practice Bulletin No. 153: Nausea and Vomiting of Pregnancy. Obstet Gynecol. 2015 Sep;126(3):e12-e24. doi: 10.1097/AOG.0000000000001048.
- Background: PubMed 1466251Hanson DA, Weis MA, Bollen AM, Maslan SL, Singer FR, Eyre DR. A specific immunoassay for monitoring human bone resorption: quantitation of type I collagen cross-linked N-telopeptides in urine. J Bone Miner Res. 1992 Nov;7(11):1251-8. doi: 10.1002/jbmr.5650071119.
- Background: PubMed 24399365Hlaing TT, Compston JE. Biochemical markers of bone turnover - uses and limitations. Ann Clin Biochem. 2014 Mar;51(Pt 2):189-202. doi: 10.1177/0004563213515190. Epub 2014 Jan 7.
- Background: PubMed 25209679Sanz-Salvador L, Garcia-Perez MA, Tarin JJ, Cano A. Bone metabolic changes during pregnancy: a period of vulnerability to osteoporosis and fracture. Eur J Endocrinol. 2015 Feb;172(2):R53-65. doi: 10.1530/EJE-14-0424. Epub 2014 Sep 10.
- Derived from this study: PubMed 30572827Sahin E, Madendag Y, Eraslan Sahin M, Tayyar AT, Col Madendag I, Gozukucuk M, Karakukcu C, Acmaz G, Muderris II. Maternal type 1collagen N-terminal telopeptide levels in severe hyperemesis gravidarum. BMC Pregnancy Childbirth. 2018 Dec 20;18(1):502. doi: 10.1186/s12884-018-2149-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erdem SAHİN study director
Kayseri Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperemesis Gravidarum, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erdem SAHİN, Study Principal İnvestigator (+905321688683, erdemsahin07@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine N- telopeptide levels in Pregnant Women with Hyperemesis Gravidarum (time frame: 4 months). The study lists 4 primary outcomes in all. 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 NCT02862496, which also lists 8 linked publications.
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 11 Aug 2016.