NCT05407558

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

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

May 27, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

June 6, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

November 2, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

May 27, 2022

Last Update Submit

November 1, 2022

Conditions

Gastric Contents

Outcome Measures

Primary Outcomes (1)

  • The difference in gastric volume between the two menstrual phases

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

    1 month

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale volunteers with active menstrual cycles
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • Female volunteers of reproductive age have had a regular menstrual cycle for at least six months

You may not qualify if:

  • Pregnancy
  • Stomach problem
  • Using anticholinergics, opioids, and oral contraceptive drugs
  • Hypothyroidism
  • Diabetes mellitus
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Betul Kozanhan

Konya, 42005, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.

Study Record Dates

First Submitted

May 27, 2022

First Posted

June 7, 2022

Study Start

June 6, 2022

Primary Completion

August 29, 2022

Study Completion

November 1, 2022

Last Updated

November 2, 2022

Record last verified: 2022-09

Locations

TU(1)