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

November 1, 2022 updated by: Betul Kozanhan, Konya Meram State Hospital
This prospective observational study aimed to evaluate the relationship between menstrual phase cycles and gastric emptying in female volunteers of reproductive age.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey, 42005
        • Betul Kozanhan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

24 healthy female volunteers who are of the reproductive age and have had a regular menstrual cycle for at least six

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in gastric volume between the two menstrual phases
Time Frame: 1 month
gastric emptying with USG will be evaluated in both phases of the menstrual phase
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya Meram State Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2022

Primary Completion (Actual)

August 29, 2022

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

May 27, 2022

First Submitted That Met QC Criteria

June 6, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Menstrual Phase Gastric USG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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