Pepsinogen-1 Serum Levels in Hyperemesis Gravidarum

NCT ID: NCT06581796

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-11-21

Brief Summary

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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

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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

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Hyperemesis Gravidarum Pregnant With Complication

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

pregnant women with hyperemesis gravidarum

pepsinogen-1

Intervention Type OTHER

association between pepsinogen 1 serum level with hyperemesis gravidarum

Control group

pregnant women without hyperemesis gravidarum

pepsinogen-1

Intervention Type OTHER

association between pepsinogen 1 serum level with hyperemesis gravidarum

Interventions

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pepsinogen-1

association between pepsinogen 1 serum level with hyperemesis gravidarum

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* A singleton pregnancy
* Between 21 and 35 years old
* Diagnosis of hyperemesis gravidarum

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Fahri Burcin Firatligil

Specialist doctor in obstetrics and gynecology and Fellow student in Perinatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sevki Celen, MD

Role: STUDY_CHAIR

Ankara Etlik City Hospital

Locations

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Ankara Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 29243850 (View on PubMed)

Han 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.

Reference Type RESULT
PMID: 33199102 (View on PubMed)

Wei 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.

Reference Type RESULT
PMID: 30287174 (View on PubMed)

Other Identifiers

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AECH-FIRATLIGIL-002

Identifier Type: -

Identifier Source: org_study_id