Anxiety in Relation to Nausea and Vomiting in Pregnancy

Ain Shams Maternity Hospital

Status: Completed

Conditions: Nausea Gravidarum; Anxiety

Treatments: Other: GAD-7; Other: PUQE score

Study type: Observational

Funder types: Other

Identifiers

NCT06059794

FMASU MS 717/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.