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Completed

NCT Number: NCT06059794

Anxiety in Relation to Nausea and Vomiting in Pregnancy

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Ain Shams Maternity Hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PUQE score

Other

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-7

Other

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"

Primary outcomes

  1. Pregnancy-Unique Quantification of Emesis (PUQE) score

    Time frame: 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).

  2. Generalised Anxiety Disorder Assessment (GAD-7)

    Time frame: 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 outcomes

  1. Disturbance in Sodium.

    Time frame: immediately after the intervention

    assessed by serum levels of Sodium.

  2. Disturbance in Potassium

    Time frame: immediately after the intervention

    assessed by serum levels of Potassium.

  3. Dehydration

    Time frame: immediately after the intervention

    dehydration as detected clinically (like oliguria)

  4. Ketonuria

    Time frame: immediately after the intervention

    acetone in urine assessed by urine dipstick

  5. Hospital admission

    Time frame: immediately after the intervention

    Hospital admission

  6. Hospital stay

    Time frame: immediately after the intervention

    Duration of hospital stay in days

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2023
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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