Nausea GravidarumNCT06059794
Anxiety in Relation to Nausea and Vomiting in Pregnancy
An observational study of Nausea Gravidarum and Anxiety, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Nausea Gravidarum, Anxiety
- What is being tested?
- PUQE score and GAD-7
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 19 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: the study will include 105 pregnant women recruited from antenatal clinic and antenatal ward
Who may be able to join
- Pregnant women in first trimester complaining of NVP
- Age (18-40) years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Anxiety Disorder in Relation to PUQE Score of Nausea and Vomiting in First Trimester 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.
Read the 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.
- Conditions
- Nausea Gravidarum, Anxiety
- Being tested
- PUQE score, GAD-7
- Keywords
- PUQE score, GAD-7 questionnaire
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUQE scoreOther
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-7Other
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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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"
Measured: Baseline
Secondary outcomes (6)
Disturbance in Sodium.
assessed by serum levels of Sodium.
Measured: immediately after the intervention
Disturbance in Potassium
assessed by serum levels of Potassium.
Measured: immediately after the intervention
Dehydration
dehydration as detected clinically (like oliguria)
Measured: immediately after the intervention
Ketonuria
acetone in urine assessed by urine dipstick
Measured: immediately after the intervention
Hospital admission
Hospital admission
Measured: immediately after the intervention
Hospital stay
Duration of hospital stay in days
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Jan 2023
- Primary completion1 Mar 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea GravidarumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Hassan Mostafa, Ain Shams Maternity Hospital
- Investigators
- Khaled IA Abdalla, MD, Study chair, Ain Shams UniversityEbtihal M El Taieb, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059794
- Sponsor's protocol ID
- FMASU MS 717/2022
- Status last verified
- Mar 2024
- First submitted
- 16 Sep 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol and analytic code will be shared after completion and publication of the study
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Anxiety Disorder in Relation to PUQE Score of Nausea and Vomiting in First Trimester Pregnancy
- ClinicalTrials.gov ID
- NCT06059794
- Acronym / sponsor ID
- FMASU MS 717/2022
- Conditions
- Nausea Gravidarum, Anxiety
- Keywords
- PUQE score, GAD-7 questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- the study will include 105 pregnant women recruited from antenatal clinic and antenatal ward
Key inclusion criteria (2 listed)
- Pregnant women in first trimester complaining of NVP
- Age (18-40) years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PUQE scoreThe 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-7The 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" | Other | – |
Primary outcome
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).
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"
6 secondary outcomes
Disturbance in Sodium.
Time frame: immediately after the intervention
Disturbance in Potassium
Time frame: immediately after the intervention
Dehydration
Time frame: immediately after the intervention
Ketonuria
Time frame: immediately after the intervention
Hospital admission
Time frame: immediately after the intervention
Hospital stay
Time frame: immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: Yes. study protocol and analytic code will be shared after completion and publication of the study
Related trials for Nausea Gravidarum
Not yet recruitingObservational study
Diagnostic and Psychometric Validation of the FRENCH HELP Scale in Hyperemesis Gravidarum
Hyperemesis Gravidarum, Nausea and Vomiting of Pregnancy
RecruitingPhase 1/2
Hyperemesis Gravidarum Risk Reduction With Metformin
Hyperemesis Gravidarum
Not yet recruiting
Tablet Ginger Versus Tablet Doxylamine Succinate in Control of Nausea and Vomiting in Pregnancy
Nausea Gravidarum, Hyperemesis Gravidarum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaled IA Abdalla, MD study chair
Ain Shams University
Ebtihal M El Taieb, MD study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nausea Gravidarum and Anxiety, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy-Unique Quantification of Emesis (PUQE) score (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.