Anxiety in Relation to Nausea and Vomiting in Pregnancy

Ain Shams Maternity Hospital102 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

102

Conditions

Nausea Gravidarum Anxiety

Interventions

PUQE scoreOTHER

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-7OTHER

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

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Outcomes

Primary Outcomes

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).

Time frame: Baseline

Generalised Anxiety Disorder Assessment (GAD-7)

Time frame: Baseline