Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT06059794
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2023-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anxiety in Relation to Nausea and Vomiting in Pregnancy
Sponsor:
Ain Shams Maternity Hospital
Organization:
Study Overview
Official Title:
Assessment of Anxiety Disorder in Relation to PUQE Score of Nausea and Vomiting in First Trimester Pregnancy
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to learn more about the relation between anxiety (assessed by GAD-7 questionnaire) and the nausea and vomiting in pregnancy (objectively measured by PUQE score).
Participants will answer 2 questionnaires: (GAD-7) for anxiety; and (PUQE score) for nausea and vomiting.
Participants will answer 2 questionnaires: (GAD-7) for anxiety; and (PUQE score) for nausea and vomiting.
Detailed Description:
Study Procedures:
* Protocol approval will be sought from the ethical committee of the department of Obstetrics \& Gynecology, Faculty of Medicine, Ain Shams University.
* Recruitment of pregnant women complaining of nausea and vomiting in pregnancy (NVP) in first trimester will be done from the outpatient clinic and antenatal ward in Ain Shams University Maternity Hospital.
* An informed written consent will be taken from all participants before enrollment in the study.
* History taking, examination, and investigations (CBC, ultrasound, acetone in urine, serum sodium, potassium, alanine transaminase (ALT), aspartate transaminase (AST), serum creatinine) will be done to identify eligible patients according to the inclusion and exclusion criteria.
* PUQE score will be calculated for each patient. Patients will be classified into 3 groups (mild, moderate, severe) accordingly.
* GAD-7 questionnaire will be calculated for each patient. Degree of anxiety will be classified into 4 groups (minimal, mild, moderate, severe) accordingly.
* Data will be recorded in a case report form.
* Statistical analysis will be done accordingly.
* Protocol approval will be sought from the ethical committee of the department of Obstetrics \& Gynecology, Faculty of Medicine, Ain Shams University.
* Recruitment of pregnant women complaining of nausea and vomiting in pregnancy (NVP) in first trimester will be done from the outpatient clinic and antenatal ward in Ain Shams University Maternity Hospital.
* An informed written consent will be taken from all participants before enrollment in the study.
* History taking, examination, and investigations (CBC, ultrasound, acetone in urine, serum sodium, potassium, alanine transaminase (ALT), aspartate transaminase (AST), serum creatinine) will be done to identify eligible patients according to the inclusion and exclusion criteria.
* PUQE score will be calculated for each patient. Patients will be classified into 3 groups (mild, moderate, severe) accordingly.
* GAD-7 questionnaire will be calculated for each patient. Degree of anxiety will be classified into 4 groups (minimal, mild, moderate, severe) accordingly.
* Data will be recorded in a case report form.
* Statistical analysis will be done accordingly.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: