NCT04785911

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

September 5, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

April 5, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

January 21, 2021

Last Update Submit

April 3, 2023

Conditions

Keywords

PUQE score

Outcome Measures

Primary Outcomes (1)

  • 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 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)

    Basline

Interventions

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

Also known as: Steroids, Anti histamine

Eligibility Criteria

Age16 Years - 46 Years
Sexfemale
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All admitted pregenent cases complaining of hyperemisis gravidarum

You may qualify if:

  • 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.

You may not qualify if:

  • Women Suffered from other diseases causing nausea and vomiting :
  • gastritis
  • renal diseases
  • Hepatic disorders
  • Throid disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tasnem iIbrahem Aboelouon

Asyut, Assuit, 71684, Egypt

Location

Related Links

MeSH Terms

Conditions

Hyperemesis Gravidarum

Interventions

SteroidsHistamine Antagonists

Condition Hierarchy (Ancestors)

Morning SicknessPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVomitingSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic CompoundsHistamine AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 21, 2021

First Posted

March 8, 2021

Study Start

September 5, 2021

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

April 5, 2023

Record last verified: 2023-04

Locations