Anxiety in Relation to Nausea and Vomiting in Pregnancy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nausea Gravidarum, Anxiety

Intervention / Treatment
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* Other: PUQE score
* Other: GAD-7


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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)|
|Other: 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disturbance in Sodium. | assessed by serum levels of Sodium. | immediately after the intervention | 
| Disturbance in Potassium | assessed by serum levels of Potassium. | immediately after the intervention | 
| Dehydration | dehydration as detected clinically (like oliguria) | immediately after the intervention | 
| Ketonuria | acetone in urine assessed by urine dipstick | immediately after the intervention | 
| Hospital admission | Hospital admission | immediately after the intervention | 
| Hospital stay | Duration of hospital stay in days | immediately after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PUQE score, GAD-7 questionnaire