Anxiety in Relation to Nausea and Vomiting in Pregnancy

NCT06059794 | Completed DMC

• 1 other identifier: FMASU MS 717/2022
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea Gravidarum; Anxiety

Keywords

PUQE score; GAD-7 questionnaire

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Disturbance in Sodium.

  immediately after the intervention

• Disturbance in Potassium

  immediately after the intervention

• Dehydration

  immediately after the intervention

• Ketonuria

  immediately after the intervention

• Hospital admission

  immediately after the intervention

Interventions

PUQE score OTHER

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)

GAD-7 OTHER

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"

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Khaled IA Abdalla, MD

  Ain Shams University

  STUDY CHAIR

• Ebtihal M El Taieb, MD

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: September 29, 2023
• Study Start: January 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 19, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: For 2 years after completion and publication of the study
• Access Criteria: An email will be sent upon reasonable request

Locations

EG (1)