Clinical trial NCT06059794: Anxiety in Relation to Nausea and Vomiting in Pregnancy
Official title: Assessment of Anxiety Disorder in Relation to PUQE Score of Nausea and Vomiting in First Trimester Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nausea Gravidarum
Anxiety
Keywords: PUQE score
GAD-7 questionnaire
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study will include 105 pregnant women recruited from antenatal clinic and antenatal ward

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pregnancy-Unique Quantification of Emesis (PUQE) score
timeFrame: Baseline
measure: Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: Baseline
Secondary outcomes:
measure: Disturbance in Sodium.
timeFrame: immediately after the intervention
measure: Disturbance in Potassium
timeFrame: immediately after the intervention
measure: Dehydration
timeFrame: immediately after the intervention
measure: Ketonuria
timeFrame: immediately after the intervention
measure: Hospital admission
timeFrame: immediately after the intervention
measure: Hospital stay
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
affiliation: Ain Shams University
name: Khaled IA Abdalla, MD
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Ebtihal M El Taieb, MD
role: STUDY_DIRECTOR
References: