Hyperemesis GravidarumNCT06581796
Pepsinogen-1 Serum Levels in Hyperemesis Gravidarum
An observational study of Hyperemesis Gravidarum and Pregnant With Complication, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators planned to investigate maternal serum pepsinogen-1 (MSPG-1) levels in pregnant women with severe hyperemesis gravidarum (HG) and pregnant women without severe HG. Read more about this study
- Who is it for?
- Ages 21 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperemesis Gravidarum, Pregnant With Complication
- What is being tested?
- pepsinogen-1
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 21 Nov 2024
- How long will I take part?
- 2 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 21 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The singleton pregnant women who were diagnosed with hyperemesis gravidarum were included in the study group (group I) and the singleton pregnant women who had a healthy pregnancy were included in the control group (group II). For each pregnant woman who met the inclusion and exclusion criteria and was eligible for Group I, the first patient in the ranking order of the files who met the criteria previously mentioned in the Materials and Methods section was selected for Group II.
Who may be able to join
- A singleton pregnancy
- Between 21 and 35 years old
- Diagnosis of hyperemesis gravidarum
Who cannot join
- Multiple pregnancy
- Fetal congenital and chromosomal abnormalities
- Chronic drug use, alcohol and smoking
- Pregnant women with diabetes or obesity, peptic ulcer or gastritis, liver and/or gallbladder disease (cholangitis or gallstones), thyroid dysfunction, urinary tract infection, celiac disease, cardiovascular or renal disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Yenimahalle
About this study
Official title: Examination of the Maternal Serum Pepsinogen-1 in Patients Diagnosed With Severe Hyperemesis Gravidarum: A Prospective Case-control Study
In this study, the investigators planned to investigate maternal serum pepsinogen-1 (MSPG-1) levels in pregnant women with severe hyperemesis gravidarum (HG) and pregnant women without severe HG.
HG is the most common cause of hospitalization in the first trimester of pregnancy and represents an economic burden on the healthcare system. Therefore, our aim in this study was to investigate whether there is a statistical difference in MSPG-1 levels between pregnant women with severe HG and pregnant women without severe HG and to determine a cut-off value for MSPG-1 levels for the indication of hospitalization of pregnant women with HG.
The study poses no risk to the pregnant woman or the fetus.
Read the detailed description
The study will enroll pregnant women in the first trimester with maternal age between 21 and 35 years who were diagnosed with hyperemesis gravidarum and had no fetal congenital or chromosomal abnormalities and who were admitted to the perinatology outpatient clinic of Etlik City Hospital. The investigators will include 40 cases with no signs and diagnosis of systemic maternal disease and no chronic drug use as a case group and 40 healthy pregnant women matched for age, gestational week and body mass index as a control group.
- Conditions
- Hyperemesis Gravidarum, Pregnant With Complication
- Being tested
- pepsinogen-1
- Keywords
- Pepsinogen, Hyperemesis, Pregnancy
- Medical subject headings
- Hyperemesis Gravidarum, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pepsinogen-1Other
association between pepsinogen 1 serum level with hyperemesis gravidarum
| Study group | Role | What they receive |
|---|---|---|
| Study group | pregnant women with hyperemesis gravidarum Receives: Other: pepsinogen-1 | |
| Control group | pregnant women without hyperemesis gravidarum Receives: Other: pepsinogen-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pepsinogen-1 serum level
pepsinogen-1 serum level was determined with blood samples taken from pregnant women with hyperemesis gravidarum and control group.
Measured: between 5 and 14 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Jul 2024
- Primary completion10 Sep 2024
- Study completion21 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hyperemesis GravidarumStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- 40 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fahri Burcin Firatligil, Ankara Etlik City Hospital
- Investigators
- Sevki Celen, MD, Study chair, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581796
- Sponsor's protocol ID
- AECH-FIRATLIGIL-002
- Status last verified
- Nov 2024
- First submitted
- 30 Aug 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available on request only due to ethical, legal or commercial reasons
Publications
Song M, Camargo MC, Weinstein SJ, Murphy G, Freedman ND, Koshiol J, Stolzenberg-Solomon RZ, Abnet CC, Mannisto S, Albanes D, Rabkin CS. Serum pepsinogen 1 and anti-Helicobacter pylori IgG antibodies as predictors of gastric cancer risk in Finnish males. Aliment Pharmacol Ther. 2018 Feb;47(4):494-503. doi: 10.1111/apt.14471. Epub 2017 Dec 15.
PubMed 29243850Han ML, Liou JM, Ser KH, Chen JC, Chen SC, Lee WJ. Changes of serum pepsinogen level and ABC classification after bariatric surgery. J Formos Med Assoc. 2021 Jun;120(6):1377-1385. doi: 10.1016/j.jfma.2020.10.029. Epub 2020 Nov 14.
PubMed 33199102Wei W, Zhang W, Li C, Kong H, Guo Z, Zhang Z, Bastien F, Gong Y, Wang H, Zhou L. Label-free detection of pepsinogen 1 and 2 by polyethylene coating Lamb microfluidic device. Biosens Bioelectron. 2019 Mar 15;129:231-237. doi: 10.1016/j.bios.2018.09.075. Epub 2018 Sep 21.
PubMed 30287174Sucu S, Firatligil FB, Kurt A, Dereli ML, Pay RE, Ozkan S. Maternal serum pepsinogen-1 levels in severe hyperemesis gravidarum and the need for hospitalization: a prospective study. BMC Pregnancy Childbirth. 2026 Mar 4;26(1):230. doi: 10.1186/s12884-026-08887-8.
PubMed 41776488
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Maternal Serum Pepsinogen-1 in Patients Diagnosed With Severe Hyperemesis Gravidarum: A Prospective Case-control Study
- ClinicalTrials.gov ID
- NCT06581796
- Acronym / sponsor ID
- AECH-FIRATLIGIL-002
- Conditions
- Hyperemesis Gravidarum, Pregnant With Complication
- Keywords
- Pepsinogen, Hyperemesis, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 3 Sep 2024 (actual)
- 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.
In this study, the investigators planned to investigate maternal serum pepsinogen-1 (MSPG-1) levels in pregnant women with severe hyperemesis gravidarum (HG) and pregnant women without severe HG.
HG is the most common cause of hospitalization in the first trimester of pregnancy and represents an economic burden on the healthcare system. Therefore, our aim in this study was to investigate whether there is a statistical difference in MSPG-1 levels between pregnant women with severe HG and pregnant women without severe HG and to determine a cut-off value for MSPG-1 levels for the indication of hospitalization of pregnant women with HG.
The study poses no risk to the pregnant woman or the fetus.
Detailed description
The study will enroll pregnant women in the first trimester with maternal age between 21 and 35 years who were diagnosed with hyperemesis gravidarum and had no fetal congenital or chromosomal abnormalities and who were admitted to the perinatology outpatient clinic of Etlik City Hospital. The investigators will include 40 cases with no signs and diagnosis of systemic maternal disease and no chronic drug use as a case group and 40 healthy pregnant women matched for age, gestational week and body mass index as a control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: pepsinogen-1pregnant women with hyperemesis gravidarum |
| Control group | – | Other: pepsinogen-1pregnant women without hyperemesis gravidarum |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The singleton pregnant women who were diagnosed with hyperemesis gravidarum were included in the study group (group I) and the singleton pregnant women who had a healthy pregnancy were included in the control group (group II). For each pregnant woman who met the inclusion and exclusion criteria and was eligible for Group I, the first patient in the ranking order of the files who met the criteria previously mentioned in the Materials and Methods section was selected for Group II.
Key inclusion criteria (3 listed)
- A singleton pregnancy
- Between 21 and 35 years old
- Diagnosis of hyperemesis gravidarum
Key exclusion criteria (4 listed)
- Multiple pregnancy
- Fetal congenital and chromosomal abnormalities
- Chronic drug use, alcohol and smoking
- Pregnant women with diabetes or obesity, peptic ulcer or gastritis, liver and/or gallbladder disease (cholangitis or gallstones), thyroid dysfunction, urinary tract infection, celiac disease, cardiovascular or renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pepsinogen-1association between pepsinogen 1 serum level with hyperemesis gravidarum | Other | Control group, Study group |
Primary outcome
Pepsinogen-1 serum level
Time frame: between 5 and 14 weeks of pregnancy
pepsinogen-1 serum level was determined with blood samples taken from pregnant women with hyperemesis gravidarum and control group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Results publication: PubMed 29243850Song M, Camargo MC, Weinstein SJ, Murphy G, Freedman ND, Koshiol J, Stolzenberg-Solomon RZ, Abnet CC, Mannisto S, Albanes D, Rabkin CS. Serum pepsinogen 1 and anti-Helicobacter pylori IgG antibodies as predictors of gastric cancer risk in Finnish males. Aliment Pharmacol Ther. 2018 Feb;47(4):494-503. doi: 10.1111/apt.14471. Epub 2017 Dec 15.
- Results publication: PubMed 33199102Han ML, Liou JM, Ser KH, Chen JC, Chen SC, Lee WJ. Changes of serum pepsinogen level and ABC classification after bariatric surgery. J Formos Med Assoc. 2021 Jun;120(6):1377-1385. doi: 10.1016/j.jfma.2020.10.029. Epub 2020 Nov 14.
- Results publication: PubMed 30287174Wei W, Zhang W, Li C, Kong H, Guo Z, Zhang Z, Bastien F, Gong Y, Wang H, Zhou L. Label-free detection of pepsinogen 1 and 2 by polyethylene coating Lamb microfluidic device. Biosens Bioelectron. 2019 Mar 15;129:231-237. doi: 10.1016/j.bios.2018.09.075. Epub 2018 Sep 21.
- Derived from this study: PubMed 41776488Sucu S, Firatligil FB, Kurt A, Dereli ML, Pay RE, Ozkan S. Maternal serum pepsinogen-1 levels in severe hyperemesis gravidarum and the need for hospitalization: a prospective study. BMC Pregnancy Childbirth. 2026 Mar 4;26(1):230. doi: 10.1186/s12884-026-08887-8.
- Individual participant dataSharing planned: Yes. Data are available on request only due to ethical, legal or commercial reasons
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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.
Sevki Celen, MD study chair
Ankara Etlik City 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 and Pregnant With Complication, run by Ankara Etlik City 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 3 inclusion and 4 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 27 Nov 2024. 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?
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?
Pepsinogen-1 serum level (time frame: between 5 and 14 weeks of pregnancy). 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 NCT06581796, which also lists 4 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 27 Nov 2024.