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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Nausea Gravidarum
• Intervention / Treatment: Other: PUQE score; Other: GAD-7

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.

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

• Study Contact: Name: Rania HM Ahmed, MD; Phone Number: 202 01200522444; Email: raneyah@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

the study will include 105 pregnant women recruited from antenatal clinic and antenatal ward

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy-Unique Quantification of Emesis (PUQE) score	The Pregnancy-Unique Quantification of Emesis (PUQE) is a scoring system to quantify the severity of nausea and vomiting of pregnancy, based on quantification of the 3 physical symptoms of (nausea, vomiting and retching).	Baseline
Generalised Anxiety Disorder Assessment (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"	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dehydration	dehydration as detected clinically (like oliguria)	immediately after the intervention
Ketonuria	acetone in urine assessed by urine dipstick	immediately after the intervention
Hospital admission	Hospital admission	immediately after the intervention
Hospital stay	Duration of hospital stay in days	immediately after the intervention
Disturbance in Sodium.	assessed by serum levels of Sodium.	immediately after the intervention
Disturbance in Potassium	assessed by serum levels of Potassium.	immediately after the intervention

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Study Chair: Khaled IA Abdalla, MD, ain shams University; Study Director: Ebtihal M El Taieb, MD, ain shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 19, 2024

Study Registration Dates

• First Submitted: September 16, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: PUQE score; GAD-7 questionnaire
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Nausea; Vomiting; Anxiety Disorders
• Other Study ID Numbers: FMASU MS 717/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: study protocol and analytic code will be shared after completion and publication of the study
• IPD Sharing Time Frame: For 2 years after completion and publication of the study
• IPD Sharing Access Criteria: An email will be sent upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No