NCT04806815

Brief Summary

The effects of COVID-19 on body systems and functions are still being investigated. ACE 2, which plays a key role in the entry of the COVID-19 virus into the cell, is also highly expressed in the ovary, uterus, vagina, and placenta in the female genital system, which can also pose a risk to female reproductive health. The aim of this study is to evaluate menstrual cycle-induced pain, fatigue and anxiety in women who suffered from COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 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

March 17, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 18, 2021

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

12 days

First QC Date

March 17, 2021

Last Update Submit

June 29, 2021

Conditions

Keywords

Menstrual ProblemCovid19Fatigue

Outcome Measures

Primary Outcomes (1)

  • Menstrual Symptom Questionnaire

    This scale was developed to assess menstrual pain and symptoms. It is a five-point Likert-type scale consisting of 24 items. Participants will be asked to give a number between 1 (never) and 5 (always) to their menstrual symptoms. Total score will be calculated by taking the total score of the items in the scale. Increasing the average score indicates that the severity of menstrual symptoms increased.

    1 day

Secondary Outcomes (2)

  • Fatigue Severity Scale

    1 day

  • Short Form Of Coronavirus Anxiety Scale

    1 day

Interventions

The following tests will be used together with the survey; * Menstrual Symptom Questionnaire * Fatigue Severity Scale * Short Form Of Coronavirus Anxiety Scale

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale individuals aged 18-45 who have had COVID-19
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study will include 200 volunteers, female individuals aged 18-45 who have had COVID-19.

You may qualify if:

  • Being between the ages of 18 and 45,
  • PCR test result positive confirmed having COVID-19 infection,
  • Women had at least one period of Menstrual cycle after COVID-19
  • Being an Internet connection,
  • To be able to speak and write in Turkish.

You may not qualify if:

  • To be in the premenaposual/postmenopausal period (to be in the transition period to menopause or in the period after menopause.)
  • Having insufficient co-operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Menstruation DisturbancesCOVID-19Fatigue

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSigns and Symptoms

Study Officials

  • Buket Akinci

    Biruni University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Proffesor

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 19, 2021

Study Start

May 18, 2021

Primary Completion

May 30, 2021

Study Completion

June 1, 2021

Last Updated

June 30, 2021

Record last verified: 2021-06

Locations