Anxiety in Relation to Nausea and Vomiting in Pregnancy

Sponsor

Ain Shams Maternity Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06059794

Collaborator

(none)

105

Enrollment

Location

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nausea Gravidarum Anxiety	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 Design

Study Type:

Observational

Anticipated Enrollment :

105 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Outcome Measures

Primary Outcome Measures

Pregnancy-Unique Quantification of Emesis (PUQE) score [Baseline]
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).
Generalised Anxiety Disorder Assessment (GAD-7) [Baseline]
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"

Secondary Outcome Measures

Electrolytes' disturbance 2. 3. 4. [immediately after the intervention]
assessed by serum levels of Sodium.
Electrolytes' disturbance 2. 3. 4. [immediately after the intervention]
assessed by serum levels of Potassium.
Dehydration [immediately after the intervention]
dehydration as detected clinically (like oliguria)
Ketonuria [immediately after the intervention]
acetone in urine assessed by urine dipstick
Hospital admission [immediately after the intervention]
Hospital admission
Hospital stay [immediately after the intervention]
Duration of hospital stay in days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams Maternity Hospital	Cairo		Egypt

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rania Hassan Mostafa, principal investigator, Ain Shams Maternity Hospital

ClinicalTrials.gov Identifier:

NCT06059794

Other Study ID Numbers:

FMASU MS 717/2022

First Posted:

Sep 29, 2023

Last Update Posted:

Sep 29, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rania Hassan Mostafa, principal investigator, Ain Shams Maternity Hospital

PUQE score

GAD-7 questionnaire

Additional relevant MeSH terms:

Nausea

Vomiting

Anxiety Disorders

Study Results

No Results Posted as of Sep 29, 2023