NCT05835076

Brief Summary

Screen of Helicobacter pylori in hyperemesis gravidarum in early pregnancy to detect the impact of the severity of the disease on pregnant women

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Status
unknown

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

Study Start

First participant enrolled

April 1, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

April 18, 2023

Last Update Submit

April 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Positive

    Positive for Helicobacter pylori

    2 days

Interventions

Stool antigen testDIAGNOSTIC_TEST

Antigen test in the stool analysis

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Cross sectional study to screen Helicobacter pylori in hyperemesis gravidarum

You may qualify if:

  • pregnant woman \<16wk

You may not qualify if:

  • pregnant woman \>16wks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Helicobacter pylori screening in hyperemesis gravidarum in early pregnancy

Study Record Dates

First Submitted

April 18, 2023

First Posted

April 28, 2023

Study Start

April 1, 2023

Primary Completion

April 1, 2024

Study Completion

June 1, 2024

Last Updated

April 28, 2023

Record last verified: 2023-04