Clinical trial NCT06581796: Pepsinogen-1 Serum Levels in Hyperemesis Gravidarum
Official title: Examination of the Maternal Serum Pepsinogen-1 in Patients Diagnosed With Severe Hyperemesis Gravidarum: A Prospective Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperemesis Gravidarum
Pregnant With Complication
Keywords: Pepsinogen
Hyperemesis
Pregnancy
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-09-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pepsinogen-1 serum level
timeFrame: between 5 and 14 weeks of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Yenimahalle
Study officials:
affiliation: Ankara Etlik City Hospital
name: Sevki Celen, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.