Hyperemesis GravidarumNCT04785911
Use of the Modified PUQE Score on Admitted Cases of Hyperemesis Gravidarum (HG) to Guide Response to Treatment
An observational study of Hyperemesis Gravidarum, run by Tasnem Abo-elouon at 1 site in Egypt.
Trial summary
Use of the PUQE score to judge the need for admission in cases of hyperemesis gravidarum Evaluation of the response to treatment by the PUQE score Read more about this study
- Who is it for?
- Ages 16 to 46 years, women only
- Conditions the study is for
- Hyperemesis Gravidarum
- What is being tested?
- Antiemetic Combinations
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2021to 1 Nov 2022
- 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 16 to 46 years
- Women only
- Child, Adult
Study population: All admitted pregenent cases complaining of hyperemisis gravidarum
Who may be able to join
- women hospitalized due to hyperemesis gravidarum with at least two out of three criteria; dehydration, weight loss > 5% of prepregnancy weight (if known) or electrolyte imbalance/ketonuria.
- Gestational age between 6_16 weeks.
Who cannot join
- Women Suffered from other diseases causing nausea and vomiting :
- gastritis
- renal diseases
- Hepatic disorders
- Throid disorders
- the gestational length was more than 16 weeks at inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of the Modified PUQE ( Pregnancy -Unique Quantification of Emesis ) Score on Admitted Cases of Hyperemesis Gravidarum (HG) to Guide Response to Treatment
Use of the PUQE score to judge the need for admission in cases of hyperemesis gravidarum Evaluation of the response to treatment by the PUQE score
Read the detailed description
Nausea and nomiting of Pregnancy (NVP) affects up to 80% of pregnant women . Severe NVP is one of the most common indications for hospital admission among pregnant women, with typical stays of between 3 and 4 days . Onset of NVP is in the first trimester. It typically starts between the fourth and seventh weeks of gestation, peaks in approximately the ninth week and resolves by the 20th week in 90% of women. If the initial onset is after 10+6 weeks of gestation, other causes need to be considered There is a broad spectrum of nausea and vomiting of pregnancy (NVP) severity, ranging from mild, occasional nausea to severe, intractable vomiting requiring hospitalisation (hyperemesis gravidarum). Hyperemesis gravidarum(HG) is defined severe, protracted nausea and vomiting associated with weight loss of more than 5% of prepregnancy weight, dehydration and electrolyte imbalances. The exact underlying pathophysiology is unknown, but etiology is believed to be multifactorial, including endocrine, gastrointestinal and environmental factors.5 Risk factors include lower maternal age, primigravidity, lower socioeconomic background and non-smoking status.
Admission for hyperemesis gravidarum depends on clinical impression by the attending or referring physician. There is a need for classification the severity of NVP to restrict admission to those who need admission. An objective and validated index of nausea and vomiting such as the Pregnancy-Unique Quantification of Emesis (PUQE) score may be used for this purpose.
This questionnaire contains three questions regarding the time-span of nausea, vomiting and retching respectively, as well as one question assessing the global psychological and physical quality of life (QOL). Initially the questionnaire evaluated symptoms during last 12 hours, but it has been modified to encompass 24 hours as well as the whole of first trimester of pregnancy The PUQE questionnaire was used in several studies to assess the effect of antiemetic treatments for emesis and hyperemesis . In this study, the role of PUQE in evaluating need for inpatient admission will be studied. Also, the response to treatment inside the hospital will be assessed
- Conditions
- Hyperemesis Gravidarum
- Being tested
- Antiemetic Combinations
- Keywords
- PUQE score
- Medical subject headings
- Hyperemesis Gravidarum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiemetic CombinationsDrug
Also called Steroids, Anti histamine
Evaluation of response to treatment of hyperemisis gravidarum (antiemetics and other methods ) by PUQE score
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect improvement of patients by 1- daily scor of PUQE score 2-BMI by kg/m2 change from day of admission to day of discharge
We can assess severity and change by daily score which detected by daily PUQE score and pre gestational BMI by kg/m2 and BMI by kg/m2 of pregenent women with hyperemisis from day of admission to hospital to day of discharge To descripe the PUQE score full text with scoring range will be attached Total score is sum of replies to each of the three questions. PUQE-24 score: Mild ≤ 6; Moderate = 7-12; Severe = 13-15.
Motherisk PUQE-24 scoring system
- the last 24 hours, for how long have you Felt nauseated or sick to your stomach? Not at all (1 ) 1hour or less (2) 2-3 hours(3) 4-6 hours (4) More than 6 hours (5)
- In the last 24 hours have you vomited Or thrown up? 7 or more Times (5) 5-6 times (4) 3-4 times(3). 1-2 times(2) I did not throw up (1)
- In the last 24 hours how many times Have you had retching or dry heaves Without bringing anything up? No time (1) 1-2 times(2) 3-4 times(3) 5-6 times (4) 7 or more times (5)
Measured: Basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start5 Sep 2021
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperemesis 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tasnem Abo-elouon
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Tasnem Abo-elouon, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785911
- Sponsor's protocol ID
- 17101318
- Status last verified
- Apr 2023
- First submitted
- 21 Jan 2021
- Last updated
- 5 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Modified PUQE ( Pregnancy -Unique Quantification of Emesis ) Score on Admitted Cases of Hyperemesis Gravidarum (HG) to Guide Response to Treatment
- ClinicalTrials.gov ID
- NCT04785911
- Acronym / sponsor ID
- 17101318
- Conditions
- Hyperemesis Gravidarum
- Keywords
- PUQE score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tasnem Abo-elouonUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 5 Sep 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 8 Mar 2021 (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.
Use of the PUQE score to judge the need for admission in cases of hyperemesis gravidarum Evaluation of the response to treatment by the PUQE score
Detailed description
Nausea and nomiting of Pregnancy (NVP) affects up to 80% of pregnant women . Severe NVP is one of the most common indications for hospital admission among pregnant women, with typical stays of between 3 and 4 days . Onset of NVP is in the first trimester. It typically starts between the fourth and seventh weeks of gestation, peaks in approximately the ninth week and resolves by the 20th week in 90% of women. If the initial onset is after 10+6 weeks of gestation, other causes need to be considered There is a broad spectrum of nausea and vomiting of pregnancy (NVP) severity, ranging from mild, occasional nausea to severe, intractable vomiting requiring hospitalisation (hyperemesis gravidarum). Hyperemesis gravidarum(HG) is defined severe, protracted nausea and vomiting associated with weight loss of more than 5% of prepregnancy weight, dehydration and electrolyte imbalances. The exact underlying pathophysiology is unknown, but etiology is believed to be multifactorial, including endocrine, gastrointestinal and environmental factors.5 Risk factors include lower maternal age, primigravidity, lower socioeconomic background and non-smoking status.
Admission for hyperemesis gravidarum depends on clinical impression by the attending or referring physician. There is a need for classification the severity of NVP to restrict admission to those who need admission. An objective and validated index of nausea and vomiting such as the Pregnancy-Unique Quantification of Emesis (PUQE) score may be used for this purpose.
This questionnaire contains three questions regarding the time-span of nausea, vomiting and retching respectively, as well as one question assessing the global psychological and physical quality of life (QOL). Initially the questionnaire evaluated symptoms during last 12 hours, but it has been modified to encompass 24 hours as well as the whole of first trimester of pregnancy The PUQE questionnaire was used in several studies to assess the effect of antiemetic treatments for emesis and hyperemesis . In this study, the role of PUQE in evaluating need for inpatient admission will be studied. Also, the response to treatment inside the hospital will be assessed
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 46 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- All admitted pregenent cases complaining of hyperemisis gravidarum
Key inclusion criteria (2 listed)
- women hospitalized due to hyperemesis gravidarum with at least two out of three criteria; dehydration, weight loss > 5% of prepregnancy weight (if known) or electrolyte imbalance/ketonuria.
- Gestational age between 6_16 weeks.
Key exclusion criteria (6 listed)
- Women Suffered from other diseases causing nausea and vomiting :
- the gestational length was more than 16 weeks at inclusion.
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 |
|---|---|---|
| Antiemetic CombinationsAlso: Steroids, Anti histamineEvaluation of response to treatment of hyperemisis gravidarum (antiemetics and other methods ) by PUQE score | Drug | – |
Primary outcome
Detect improvement of patients by 1- daily scor of PUQE score 2-BMI by kg/m2 change from day of admission to day of discharge
Time frame: Basline
We can assess severity and change by daily score which detected by daily PUQE score and pre gestational BMI by kg/m2 and BMI by kg/m2 of pregenent women with hyperemisis from day of admission to hospital to day of discharge To descripe the PUQE score full text with scoring range will be attached Total score is sum of replies to each of the three questions. PUQE-24 score: Mild ≤ 6; Moderate = 7-12; Severe = 13-15. Motherisk PUQE-24 scoring system 1. the last 24 hours, for how long have you Felt nauseated or sick to your stomach? Not at all (1 ) 1hour or less (2) 2-3 hours(3) 4-6 hours (4) More than 6 hours (5) 2. In the last 24 hours have you vomited Or thrown up? 7 or more Times (5) 5-6 times (4) 3-4 times(3). 1-2 times(2) I did not throw up (1) 3. In the last 24 hours how many times Have you had retching or dry heaves Without bringing anything up? No time (1) 1-2 times(2) 3-4 times(3) 5-6 times (4) 7 or more times (5)
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 5 Apr 2023.
- Epidemiology of vomiting in early pregnancy.Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hyperemesis Gravidarum, run by Tasnem Abo-elouon 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 5 Apr 2023. 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?
Detect improvement of patients by 1- daily scor of PUQE score 2-BMI by kg/m2 change from day of admission to day of discharge (time frame: Basline). 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 5 Apr 2023.