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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06059794
Other study ID # FMASU MS 717/2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date March 19, 2024

Study information

Verified date March 2024
Source Ain Shams Maternity Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date March 19, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)
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"

Locations

Country Name City State
Egypt Ain Shams Maternity Hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

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