Assessment of Anxiety Disorder in Relation to PUQE Score of Nausea and Vomiting in First Trimester Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Generalised Anxiety Disorder Assessment (GAD-7)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women in first trimester complaining of NVP
- •Age (18-40) years
排除标准
- •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.
结局指标
主要结局
Generalised Anxiety Disorder Assessment (GAD-7)
时间窗: 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"
Pregnancy-Unique Quantification of Emesis (PUQE) score
时间窗: 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).
次要结局
- Disturbance in Potassium(immediately after the intervention)
- Disturbance in Sodium.(immediately after the intervention)
- Dehydration(immediately after the intervention)
- Ketonuria(immediately after the intervention)
- Hospital admission(immediately after the intervention)
- Hospital stay(immediately after the intervention)
研究者
Rania Hassan Mostafa
principal investigator
Ain Shams Maternity Hospital