Anxiety, Nausea Gravidarum
Conditions
Keywords
PUQE score, GAD-7 questionnaire
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.
Interventions
OTHERPUQE 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)
OTHERGAD-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
Sponsors
Ain Shams Maternity Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Dehydration | immediately after the intervention | dehydration as detected clinically (like oliguria) |
| Ketonuria | immediately after the intervention | acetone in urine assessed by urine dipstick |
| Disturbance in Sodium. | immediately after the intervention | assessed by serum levels of Sodium. |
| Hospital stay | immediately after the intervention | Duration of hospital stay in days |
| Hospital admission | immediately after the intervention | Hospital admission |
| Disturbance in Potassium | immediately after the intervention | assessed by serum levels of Potassium. |
Countries
Egypt
Outcome results
None listed