NCT04413058

Brief Summary

The Covid-19 pandemic has impacted healthcare workers physically and psychologically. The aim of this study is to examine whether there is a change in menstrual cycle characteristics during pandemia. The aim of this study is to investigate whether there is an association between covid infection and menstrual cycle changes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

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

Study Start

First participant enrolled

April 10, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2020

Completed
Last Updated

November 19, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

May 27, 2020

Last Update Submit

November 18, 2020

Conditions

Menstrual IrregularityCovid 19

Keywords

health care professionalsmenstrual cycleCovid 19Pandemia

Outcome Measures

Primary Outcomes (5)

  • Rate of irregular menstrual cycle

    Irregular menstrual cycle

    1 month after starting to work at pandemic clinic

  • Length of cycle

    Length of cycle (day)

    1 month after starting to work at pandemic clinic

  • Rate of prolonged bleeding

    Duration of bleeding (day)

    1 month after starting to work at pandemic clinic

  • Amount of flow

    Number of used tampons during bleeding

    1 month after starting to work at pandemic clinic

  • Rate of dysmenorrhea

    Dysmenorrhea status

    1 month after starting to work at pandemic clinic

Secondary Outcomes (3)

  • The number of difference in menstrual cycle length

    Up to 1 month after covid infection

  • The number of difference in bleeding days

    Up to 1 month after covid infection

  • The number of difference in amount of flow

    Up to 1 month after covid infection

Study Arms (1)

Female healthcare workers

Healthy female healthcare workers at Covid 19 clinic in Istanbul, Turkey

Eligibility Criteria

Age18 Years - 47 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy female healthcare workers at Covid 19 pandemic hospital

You may qualify if:

  • Working at Covid 19 Pandemic Hospital
  • Being at between 18 and 47 years old
  • Having menstruation

You may not qualify if:

  • Oral contraceptive users
  • Pregnants
  • Having malignancy
  • Having primary amenorrhea
  • Being at menopause
  • Lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Turkey

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • Attarchi M, Darkhi H, Khodarahmian M, Dolati M, Kashanian M, Ghaffari M, Mirzamohammadi E, Mohammadi S. Characteristics of menstrual cycle in shift workers. Glob J Health Sci. 2013 Feb 28;5(3):163-72. doi: 10.5539/gjhs.v5n3p163.

    PMID: 23618486BACKGROUND

  • Moen BE, Baste V, Morken T, Alsaker K, Pallesen S, Bjorvatn B. Menstrual characteristics and night work among nurses. Ind Health. 2015;53(4):354-60. doi: 10.2486/indhealth.2014-0214. Epub 2015 Apr 24.

    PMID: 25914071BACKGROUND

  • Ok G, Ahn J, Lee W. Association between irregular menstrual cycles and occupational characteristics among female workers in Korea. Maturitas. 2019 Nov;129:62-67. doi: 10.1016/j.maturitas.2019.07.019. Epub 2019 Aug 2.

    PMID: 31547916BACKGROUND

  • Wan GH, Chung FF. Working conditions associated with ovarian cycle in a medical center nurses: a Taiwan study. Jpn J Nurs Sci. 2012 Jun;9(1):112-8. doi: 10.1111/j.1742-7924.2011.00191.x. Epub 2011 Sep 16.

    PMID: 22583945BACKGROUND

MeSH Terms

Conditions

Menstruation DisturbancesCOVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Principal Investigator

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 2, 2020

Study Start

April 10, 2020

Primary Completion

September 10, 2020

Study Completion

September 10, 2020

Last Updated

November 19, 2020

Record last verified: 2020-05

Locations

TU(1)