Use of the Modified PUQE Score on Admitted Cases of Hyperemesis Gravidarum (HG) to Guide Response to Treatment

NCT ID: NCT04785911

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-05
• Study Completion Date: 2022-11-01

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

Conditions

Hyperemesis Gravidarum

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Antiemetic Combinations

Evaluation of response to treatment of hyperemisis gravidarum (antiemetics and other methods ) by PUQE score

Intervention Type: DRUG

Other Intervention Names

Steroids; Anti histamine

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 46 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: collaborator

Tasnem Abo-elouon

OTHER

Sponsor Role: lead

Responsible Party

Tasnem Abo-elouon

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tasnem iIbrahem Aboelouon

Asyut, Assuit, Egypt

Countries

Egypt

Related Links

http://europepmc.org/article/med/3903578

Epidemiology of vomiting in early pregnancy.

Other Identifiers

17101318

Identifier Type: -

Identifier Source: org_study_id