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MAGUSG: Does the Menstrual Phase Affect Gastric Emptying? Prospective, Observational Study

Sponsor
Konya Meram State Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05407558
Collaborator
(none)
24
Enrollment
1
Location
2.9
Anticipated Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This prospective observational study aimed to evaluate the relationship between menstrual phase cycles and gastric emptying in female volunteers of reproductive age.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Volunteers included in the study will be evaluated for gastric emptying with USG in both phases of the menstrual phase. In each phase, volunteers will be evaluated for gastric emptying of both liquid food intake and a light meal. At first, 400 ml of water will be drunk after 10 hours of fasting, and gastric content will be evaluated with USG after 2 hours.

    Secondly, after 10 hours of fasting, solid food intake will be evaluated. Then, after taking a light meal (toast and 200 ml tea), the volunteers will be evaluated by USG at the 6th hour.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    24 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Does the Menstrual Phase Affect Gastric Emptying? Prospective, Observational Study
    Actual Study Start Date :
    Jun 6, 2022
    Anticipated Primary Completion Date :
    Aug 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. The difference in gastric volume between the two menstrual phases [1 month]

      gastric emptying with USG will be evaluated in both phases of the menstrual phase

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Female volunteers of reproductive age have had a regular menstrual cycle for at least six months
    Exclusion Criteria:

    • Pregnancy

    • Stomach problem

    • Using anticholinergics, opioids, and oral contraceptive drugs

    • Hypothyroidism

    • Diabetes mellitus

    • Smokers

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Betul Kozanhan Konya Turkey 42005

    Sponsors and Collaborators

    • Konya Meram State Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Betul Kozanhan, Ass.Prof., Konya Meram State Hospital
    ClinicalTrials.gov Identifier:
    NCT05407558
    Other Study ID Numbers:
    • Menstrual Phase Gastric USG
    First Posted:
    Jun 7, 2022
    Last Update Posted:
    Jun 7, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 7, 2022