Pepsinogen-1 Serum Levels in Hyperemesis Gravidarum

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.

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Key information

Conditions

Hyperemesis Gravidarum Female Urogenital Diseases and Pregnancy Complications Morning Sickness Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnant With Complication Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases Vomiting

Age range

21 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Ankara Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pepsinogen-1

Other

association between pepsinogen 1 serum level with hyperemesis gravidarum

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

Examination of the Maternal Serum Pepsinogen-1 in Patients Diagnosed With Severe Hyperemesis Gravidarum: A Prospective Case-control Study

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Sep 3, 2024
Registry last updated: Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed