Pepsinogen-1 Serum Levels in Hyperemesis Gravidarum

NCT06581796 | Completed

• 1 other identifier: AECH-FIRATLIGIL-002
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperemesis Gravidarum; Pregnant With Complication

Keywords

Pepsinogen; Hyperemesis; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Pepsinogen-1 serum level

  pepsinogen-1 serum level was determined with blood samples taken from pregnant women with hyperemesis gravidarum and control group.

  between 5 and 14 weeks of pregnancy

Study Arms (2)

Study group

pregnant women with hyperemesis gravidarum

Other: pepsinogen-1

Control group

pregnant women without hyperemesis gravidarum

Other: pepsinogen-1

Interventions

pepsinogen-1 OTHER

association between pepsinogen 1 serum level with hyperemesis gravidarum

Control group; Study group

Eligibility Criteria

• Age: 21 Years - 35 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 29243850 RESULT

• 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.

  PMID: 33199102 RESULT

• 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.

  PMID: 30287174 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Singleton nulliparous pregnant women who had been diagnosed with hyperemesis gravidarum in first trimester had blood samples taken at 8:00 am on the first visit to the outpatient clinic after an 8-hour fasting state

MeSH Terms

Conditions

Hyperemesis Gravidarum; Pregnancy Complications

Condition Hierarchy (Ancestors)

Morning Sickness; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sevki Celen, MD

  Ankara Etlik City Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist doctor in obstetrics and gynecology and Fellow student in Perinatology

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: July 1, 2024
• Primary Completion: September 10, 2024
• Study Completion: November 21, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: two or three months

Locations

TU (1)