Menstrual IrregularityNCT04413058
Menstrual Cycle Characteristics of Healthcare Professionals
An observational study of Menstrual Irregularity and Covid 19, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Irregularity, Covid 19
- How many people
- 260 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2020to 10 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 47 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy female healthcare workers at Covid 19 pandemic hospital
Who may be able to join
- Working at Covid 19 Pandemic Hospital
- Being at between 18 and 47 years old
- Having menstruation
Who cannot join
- Oral contraceptive users
- Pregnants
- Having malignancy
- Having primary amenorrhea
- Being at menopause
- Lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Menstrual Cycle Characteristics of Healthcare Professionals at Covid 19 Pandemic Hospital
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.
Read the detailed description
The Covid-19 pandemic has impacted healthcare workers physically and psychologically. Healthcare workers have ben required to work under stressful conditions and take difficult decisions involving ethical implications. Increasing work demands on healthcare professionals conflict with their duties to family and friends, which causes psychological stress. All of these factors may negatively affect their menstrual cycle.
The aim of this study is to examine whether there is a change in menstrual cycle characteristics during pandemia. Second aim is to investigate whether there is an association between Covid 19 infection and menstrual cycle changes.
This cross-sectional study is conducted with healthy female participants who are working at Haydarpasa Numune Research and Training Hospital in Turkey. The researcher investigates the characteristics of menstrual cycle in female healthy workers employed in Covid 19 pandemic inpatient and outpatient clinics. The participants who are sure about their pertinent information are enrolled in the study. The exclusion criteria includes pregnancy, history of hysterectomy, oophorectomy, diseases like Asherman's syndrome and also history of endocrine disorders (progesterone deficiency, thyroid disorders and diabetes mellitus), oral contraceptive use, malignancy, primary amenorrhea, menopause and lactation.
After informed consent, detailed information is collected using structured questionnaires about their reproductive factors and menstrual cycles by direct interviews. The questionnaire contains questions about age, work experience, marital status, height, weight, working hours, use of medication, menstrual cycle characteristics (including cycle duration, duration and amount of bleeding, bleeding during the cycle, regular or irregular menstrual cycles) and dysmenorrhea. Also, the difference in menstrual cycle characteristics between covid positive and negative healthcare professionals is investigated.
- Conditions
- Menstrual Irregularity, Covid 19
- Keywords
- health care professionals, menstrual cycle, Covid 19, Pandemia
- Medical subject headings
- Menstruation Disturbances, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Female healthcare workers | Healthy female healthcare workers at Covid 19 clinic in Istanbul, Turkey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of irregular menstrual cycle
Irregular menstrual cycle
Measured: 1 month after starting to work at pandemic clinic
Length of cycle
Length of cycle (day)
Measured: 1 month after starting to work at pandemic clinic
Rate of prolonged bleeding
Duration of bleeding (day)
Measured: 1 month after starting to work at pandemic clinic
Amount of flow
Number of used tampons during bleeding
Measured: 1 month after starting to work at pandemic clinic
Rate of dysmenorrhea
Dysmenorrhea status
Measured: 1 month after starting to work at pandemic clinic
Secondary outcomes (3)
The number of difference in menstrual cycle length
Menstrual cycle difference between covid positive and negative healthcare workers (days)
Measured: Up to 1 month after covid infection
The number of difference in bleeding days
Duration of bleeding difference between covid positive and negative healthcare workers (days)
Measured: Up to 1 month after covid infection
The number of difference in amount of flow
Amount of flow difference between covid positive and negative healthcare workers (tampons)
Measured: Up to 1 month after covid infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start10 Apr 2020
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Menstrual IrregularityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevcan Arzu Arinkan, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413058
- Sponsor's protocol ID
- HNEAH KAEK 2020/KK/
- Other IDs
- Ministry of Health
- Status last verified
- May 2020
- First submitted
- 27 May 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23618486Moen 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.
PubMed 25914071Ok 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.
PubMed 31547916Wan 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.
PubMed 22583945
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menstrual Cycle Characteristics of Healthcare Professionals at Covid 19 Pandemic Hospital
- ClinicalTrials.gov ID
- NCT04413058
- Acronym / sponsor ID
- HNEAH KAEK 2020/KK/
- Conditions
- Menstrual Irregularity, Covid 19
- Keywords
- health care professionals, menstrual cycle, Covid 19, Pandemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Covid-19 pandemic has impacted healthcare workers physically and psychologically. Healthcare workers have ben required to work under stressful conditions and take difficult decisions involving ethical implications. Increasing work demands on healthcare professionals conflict with their duties to family and friends, which causes psychological stress. All of these factors may negatively affect their menstrual cycle.
The aim of this study is to examine whether there is a change in menstrual cycle characteristics during pandemia. Second aim is to investigate whether there is an association between Covid 19 infection and menstrual cycle changes.
This cross-sectional study is conducted with healthy female participants who are working at Haydarpasa Numune Research and Training Hospital in Turkey. The researcher investigates the characteristics of menstrual cycle in female healthy workers employed in Covid 19 pandemic inpatient and outpatient clinics. The participants who are sure about their pertinent information are enrolled in the study. The exclusion criteria includes pregnancy, history of hysterectomy, oophorectomy, diseases like Asherman's syndrome and also history of endocrine disorders (progesterone deficiency, thyroid disorders and diabetes mellitus), oral contraceptive use, malignancy, primary amenorrhea, menopause and lactation.
After informed consent, detailed information is collected using structured questionnaires about their reproductive factors and menstrual cycles by direct interviews. The questionnaire contains questions about age, work experience, marital status, height, weight, working hours, use of medication, menstrual cycle characteristics (including cycle duration, duration and amount of bleeding, bleeding during the cycle, regular or irregular menstrual cycles) and dysmenorrhea. Also, the difference in menstrual cycle characteristics between covid positive and negative healthcare professionals is investigated.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female healthcare workers | – | –Healthy female healthcare workers at Covid 19 clinic in Istanbul, Turkey |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy female healthcare workers at Covid 19 pandemic hospital
Key inclusion criteria (3 listed)
- Working at Covid 19 Pandemic Hospital
- Being at between 18 and 47 years old
- Having menstruation
Key exclusion criteria (6 listed)
- Oral contraceptive users
- Pregnants
- Having malignancy
- Having primary amenorrhea
- Being at menopause
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of irregular menstrual cycle
Time frame: 1 month after starting to work at pandemic clinic
Irregular menstrual cycle
Length of cycle
Time frame: 1 month after starting to work at pandemic clinic
Length of cycle (day)
Rate of prolonged bleeding
Time frame: 1 month after starting to work at pandemic clinic
Duration of bleeding (day)
Amount of flow
Time frame: 1 month after starting to work at pandemic clinic
Number of used tampons during bleeding
Rate of dysmenorrhea
Time frame: 1 month after starting to work at pandemic clinic
Dysmenorrhea status
3 secondary outcomes
The number of difference in menstrual cycle length
Time frame: Up to 1 month after covid infection
The number of difference in bleeding days
Time frame: Up to 1 month after covid infection
The number of difference in amount of flow
Time frame: Up to 1 month after covid infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Background: PubMed 23618486Attarchi 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.
- Background: PubMed 25914071Moen 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.
- Background: PubMed 31547916Ok 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.
- Background: PubMed 22583945Wan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Irregularity and Covid 19, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of irregular menstrual cycle (time frame: 1 month after starting to work at pandemic clinic). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04413058, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.