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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04413058
Other study ID # HNEAH KAEK 2020/KK/
Secondary ID Ministry of Heal
Status Completed
Phase
First received
Last updated
Start date April 10, 2020
Est. completion date September 10, 2020

Study information

Verified date May 2020
Source Haydarpasa Numune Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. The aim of this study is to investigate whether there is an association between covid infection and menstrual cycle changes.


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.


Recruitment information / eligibility

Status Completed
Enrollment 260
Est. completion date September 10, 2020
Est. primary completion date September 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 47 Years
Eligibility Inclusion Criteria: - Working at Covid 19 Pandemic Hospital - Being at between 18 and 47 years old - Having menstruation Exclusion Criteria: - Oral contraceptive users - Pregnants - Having malignancy - Having primary amenorrhea - Being at menopause - Lactation

Study Design


Locations

Country Name City State
Turkey University of Health Sciences Turkey Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Haydarpasa Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of irregular menstrual cycle Irregular menstrual cycle 1 month after starting to work at pandemic clinic
Primary Length of cycle Length of cycle (day) 1 month after starting to work at pandemic clinic
Primary Rate of prolonged bleeding Duration of bleeding (day) 1 month after starting to work at pandemic clinic
Primary Amount of flow Number of used tampons during bleeding 1 month after starting to work at pandemic clinic
Primary Rate of dysmenorrhea Dysmenorrhea status 1 month after starting to work at pandemic clinic
Secondary The number of difference in menstrual cycle length Menstrual cycle difference between covid positive and negative healthcare workers (days) Up to 1 month after covid infection
Secondary The number of difference in bleeding days Duration of bleeding difference between covid positive and negative healthcare workers (days) Up to 1 month after covid infection
Secondary The number of difference in amount of flow Amount of flow difference between covid positive and negative healthcare workers (tampons) Up to 1 month after covid infection
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