Anxiety in Relation to Nausea and Vomiting in Pregnancy

NCT ID: NCT06059794

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-03-19

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

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)

Intervention Type: 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"

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Pregnant women in first trimester complaining of NVP
• Age (18-40) years

Exclusion Criteria

• History of known medical problem (e.g., endocrine abnormalities, gastrointestinal disease).
• Known current or past psychiatric disorder (e.g., depression, anxiety, bipolar disorder, delirium, eating disorders, and psychotic disorder)
• Multiple pregnancy
• Known obstetric complications (non-viable pregnancy; either ectopic pregnancy; gestational trophoblastic disease, or miscarriage).
• Medications (including antidepressant, anti-psychotic or other psychiatric drugs during the last 6 months) or illegal drug or narcotic use that would affect the test results
• Current or past history of cognitive incompetence which can make it difficult to understand how to score GAD-7 questionnaire.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rania Hassan Mostafa

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khaled IA Abdalla, MD

Role: STUDY_CHAIR

Ain Shams University

Ebtihal M El Taieb, MD

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Ain Shams Maternity Hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU MS 717/2022

Identifier Type: -

Identifier Source: org_study_id