NCT06059794

Anxiety in Relation to Nausea and Vomiting in Pregnancy

Assessment of Anxiety Disorder in Relation to PUQE Score of Nausea and Vomiting in First Trimester Pregnancy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 102 (actual)
• Sponsor: Ain Shams Maternity Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Nausea Gravidarum
• Anxiety

Interventions

Type	Name	Description
OTHER	PUQE score	The Pregnancy-Unique Quantification of Emesis (PUQE) is a scoring system to quantify the severity of nausea and vomiting of pregnancy (NVP). Based on quantification of the 3 physical symptoms of NVP (nausea, vomiting and retching)
OTHER	GAD-7	The Generalised Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Response options include "not at all", "several days", "more than half the days" and "nearly every day"

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-03-01
• Completion: 2024-03-19
• First posted: 2023-09-29
• Last updated: 2024-03-20

Locations

1 site across 1 country: Egypt