Inflammation Markers in Hyperemesis Gravidarum | NCT06245811

Studies
Inflammation Markers in Hyperemesis Gravidarum

NCT06245811

Sponsor

Izzet Celegen

Status

Completed

Last Update Posted

Feb 7, 2024Actual

Enrollment

215Actual

Phase

Not provided

Conditions

Hyperemesis Gravidarum

Interventions

Not provided

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

Jan 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

Jan 20, 2022Actual

Primary Completion Date

Mar 20, 2022Actual

Completion Date

Jun 20, 2022Actual

First Submitted Date

Jan 30, 2024

First Submission Date that Met QC Criteria

Feb 6, 2024

First Posted Date

Feb 7, 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

Feb 6, 2024

Last Update Posted Date

Feb 7, 2024Actual

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 relationship between the severity of hyperemesis gravidarum (HEG) disease and subclinical inflammatory factors such as Platelet Crit (PCT), Hemoglobin/red cell distribution width ratio (HRR), Neutrophil/lymphocyte ratio (NLR), was investigated.

Detailed Description

A total of 215 pregnant women, 102 with hyperemesis gravidarum and 113 healthy pregnant women, were included in the study. HEG patients were divided into three groups according to the modified PUQE classification: mild (n=38), moderate (n=32) and severe (n=32).

In our study, we proposed using a new prognostic marker for HEG patients. We think that our study will be a source for future studies on HEG.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

215Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Pregnancy Unique Quantification of Emesis/Stomach scoring system	1: Weight loss of 5% or more since the beginning of pregnancy 2: Vomiting at least three times a day 3: A ketonuria value of +1 or higher on a urinalysis test	2 months

Secondary Outcomes

Measure	Description	Time Frame
Body mass index	(BMI) (kg/m2) was obtained by dividing body weight (kg) by height (m2) squared	2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy pregnant women over 18 years of age
5-16 weeks of gestation.

Exclusion Criteria:

Smoking, urinary tract infections, previously diagnosed psychological disorders, gastrointestinal disorders, multiple pregnancies, eating disorders, thyroid disorders, inflammatory disease, pregnancy with assisted fertilization technique.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Healthy pregnant women over 18 years of age, 5-16 weeks of gestation.

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

A total of 213 pregnant women, including 102 pregnant women with hyperemesis gravidarum and 113 healthy pregnant women between 5-16 weeks of age, were included in the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kazım Uçkan	Yuzuncu Yil University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yuzuncu Yil University, Faculty of Medicine		Van			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D006939	Hyperemesis Gravidarum

Ancestor Terms

ID	Term
D048968	Morning Sickness
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

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Browse Branches

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