Pepsinogen-1 Serum Levels in Hyperemesis Gravidarum

Completed

• Conditions: Hyperemesis Gravidarum; Pregnant With Complication
• Interventions: Other: pepsinogen-1

• Registration Number: NCT06581796
• Lead Sponsor: Ankara Etlik City Hospital

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.

Study Timeline

• Study Start: 2024-07-01
• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-08-30
• Study First Posted: 2024-09-03
• Primary Completion: 2024-09-10
• Status Verified: 2024-11
• Study Completion: 2024-11-21
• Last Update Submitted: 2024-11-24
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	pepsinogen-1	pregnant women with hyperemesis gravidarum
Control group	pepsinogen-1	pregnant women without hyperemesis gravidarum

Primary Outcome Measures

Name	Time	Method
Pepsinogen-1 serum level	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.

Trial Locations

Locations (1)

Ankara Etlik City Hospital; 🇹🇷 Ankara, Yenimahalle, Turkey