Pepsinogen-1 Serum Levels in Hyperemesis Gravidarum | NCT06581796

Studies
Pepsinogen-1 Serum Levels in Hyperemesis Gravidarum

NCT06581796

Sponsor

Ankara Etlik City Hospital

Status

Completed

Last Update Posted

Nov 27, 2024Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Hyperemesis Gravidarum
Pregnant With Complication

Interventions

pepsinogen-1

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2024Actual

Primary Completion Date

Sep 10, 2024Actual

Completion Date

Nov 21, 2024Actual

First Submitted Date

Aug 30, 2024

First Submission Date that Met QC Criteria

Aug 30, 2024

First Posted Date

Sep 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2024

Last Update Posted Date

Nov 27, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fahri Burcin Firatligil, Specialist doctor in obstetrics and gynecology and Fellow student in Perinatology, Ankara Etlik City HospitalPrincipal Investigator

Lead Sponsor

Ankara Etlik City HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		pregnant women with hyperemesis gravidarum	Other: pepsinogen-1
Control group		pregnant women without hyperemesis gravidarum	Other: pepsinogen-1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pepsinogen-1	Other	association between pepsinogen 1 serum level with hyperemesis gravidarum	Control group Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women

Minimum Age

21 Years

Maximum Age

35 Years

Standard Ages

Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sevki Celen, MD	Ankara Etlik City Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara Etlik City Hospital		Ankara	Yenimahalle		Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29243850	Result	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.
33199102

ID	Term
D006939	Hyperemesis Gravidarum
D011248	Pregnancy Complications

ID	Term
D048968	Morning Sickness
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D014839	Vomiting