Clinical trial NCT04785911: Use of the Modified PUQE Score on Admitted Cases of Hyperemesis Gravidarum (HG) to Guide Response to Treatment
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperemesis Gravidarum
Keywords: PUQE score
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2021-03-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 46
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All admitted pregenent cases complaining of hyperemisis gravidarum

Brief 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

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

1. Women Suffered from other diseases causing nausea and vomiting :

   * gastritis
   * renal diseases
   * Hepatic disorders
   * Throid disorders
2. the gestational length was more than 16 weeks at inclusion.

Primary outcomes:
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
timeFrame: Basline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Tasnem iIbrahem Aboelouon
state: Assuit
Study officials:
References: