Anxiety in Relation to Nausea and Vomiting in Pregnancy

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06059794
• Other study ID #: FMASU MS 717/2022
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Nausea
• Nausea Gravidarum
• Vomiting

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