Menstrual IrregularityNCT05197491
Women's Menstruation During the Covid-19 Pandemic
An observational study of Menstrual Irregularity and Stress Related Disorder, run by Fayoum University at 1 site in Egypt.
Trial summary
The COVID-19 crisis has rapidly become the most significant public health crisis of our times. It has particularly impacted healthcare workers (HCW) due to the over-whelming of healthcare resources, as well as a critical absence of protective equipment and risk to their own health as well as the risk of exposure to… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Irregularity, Stress Related Disorder, COVID-19 Pneumonia
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 Dec 2023
- 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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: A COVID-19 survey in electronic or hard copy format for healthcare workers include physicians, nurses, emergency medical personnel, medical and nursing students, and administrative staff. The survey included questions about the respondents' demographic characteristics, changes in their practice during the pandemic period, and basic knowledge of COVID-19. Furthermore, questions evaluating fear and stress associated with the pandemic. In addition, the change in the character of the menstrual cycle and sexual life. The participants will be informed that the survey will be intended for research and that their participation will be anonymous. Participants did not have to answer all the questions in order to complete the survey.
Who may be able to join
- All obstetrics and gynecology department healthcare workers who were or had been resident, physicians or consultant physicians, nurses, and paramedical healthcare active during the COVID-19 pandemic period at a designated Fayoum university hospital, regardless of gender, age, experience, and duration of employment.
Who cannot join
- physicians who were retired or did not currently work in a designated COVID-19 hospital.
- Physicians from other specialties
- Physicians were on leave during the pandemic for various reasons.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Fayoum university
Al Fayyum, 63514
rehab A aboshama, ass professor, 01156608221 ext. +2, ras07@fayoum.edu.eg
About this study
Official title: Recognizing Menstrual Disturbance During COVID-19 Pandemic Among Obstetrics and Gynecology Healthcare Professionals, Fayoum University Hospital.
The COVID-19 crisis has rapidly become the most significant public health crisis of our times. It has particularly impacted healthcare workers (HCW) due to the over-whelming of healthcare resources, as well as a critical absence of protective equipment and risk to their own health as well as the risk of exposure to their family. All these factors have likely resulted in significant levels of stress, anxiety, and affection of the general health
Read the detailed description
During the first wave of the pandemic, overstretched healthcare systems left health workers in hard-hit countries struggling with long working hours, fatigue, and extreme psychological stress. Rapidly vanishing supplies, national lockdown, and a feeding frenzy on the open market for personal protective equipment (PPE) led to shortages. Healthcare workers often had to care for patients with suspected or confirmed COVID-19 infection without proper training or adequate PPE. This contributed to an increased risk to healthcare workers during the initial phase of the pandemic.
Study Methods:
This is a retrospective cross-sectional study that will be conducted among healthcare professionals working in the obstetrics and gynecology department, Fayoum University Fayoum, Egypt. A survey-based study will be conducted between January 15 and March 1, 2022, using the database of Fayoum University. A self-administered online survey consisting of 80 questions was developed.
- Keywords
- COVID-19, Work-related stress, Health care worker, Survey, Menstrual irregularity
- Medical subject headings
- Menstruation Disturbances, Anxiety Disorders, COVID-19, Occupational Stress
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: 6 month after working in the pandemic
Length of cycle
Length of cycle (days)
Measured: 6 month after working in the pandemic
Rate of prolonged bleeding per cycle
Duration of bleeding (day)
Measured: 6 month after working in the pandemic
Amount of flow
Number of used tampons (pads) during bleeding
Measured: 6 month after working in the pandemic
Rate of dysmenorrhea
Dysmenorrhea status
Measured: 6 month after working in the pandemic
Recognizing the stress related to work in the Covid-19 pandemic
The person is asked to answer the questions on the scale over the symptoms she has experienced during the past year including today'. Each item scores between 0 and 3 as none, mild, moderate, and severe, respectively.
Measured: 6 month after working in the pandemic
Recognizing a change in sexual life
The participants will answer the survey by yes or no.
Measured: 6 month after working in the pandemic
Secondary outcomes (3)
The number of differences in menstrual cycle length
Menstrual cycle difference between Covid-19 positive and negative healthcare workers (days)
Measured: 6 month after working in the pandemic
The number of differences in bleeding days
Duration of bleeding difference between covid positive and negative healthcare workers (days)
Measured: 6 month after working in the pandemic
The number of differences in the amount of flow
Amount of flow difference between covid positive and negative healthcare workers (tampons)
Measured: 6 month after working in the pandemic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Apr 2022
- Primary completionAug 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual IrregularityStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehab abdelhamid aboshama, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197491
- Sponsor's protocol ID
- R 179
- Status last verified
- Apr 2023
- First submitted
- 7 Jan 2022
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recognizing Menstrual Disturbance During COVID-19 Pandemic Among Obstetrics and Gynecology Healthcare Professionals, Fayoum University Hospital.
- ClinicalTrials.gov ID
- NCT05197491
- Acronym / sponsor ID
- R 179
- Keywords
- COVID-19, Work-related stress, Health care worker, Survey, Menstrual irregularity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 19 Jan 2022 (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 crisis has rapidly become the most significant public health crisis of our times. It has particularly impacted healthcare workers (HCW) due to the over-whelming of healthcare resources, as well as a critical absence of protective equipment and risk to their own health as well as the risk of exposure to their family. All these factors have likely resulted in significant levels of stress, anxiety, and affection of the general health
Detailed description
During the first wave of the pandemic, overstretched healthcare systems left health workers in hard-hit countries struggling with long working hours, fatigue, and extreme psychological stress. Rapidly vanishing supplies, national lockdown, and a feeding frenzy on the open market for personal protective equipment (PPE) led to shortages. Healthcare workers often had to care for patients with suspected or confirmed COVID-19 infection without proper training or adequate PPE. This contributed to an increased risk to healthcare workers during the initial phase of the pandemic.
Study Methods:
This is a retrospective cross-sectional study that will be conducted among healthcare professionals working in the obstetrics and gynecology department, Fayoum University Fayoum, Egypt. A survey-based study will be conducted between January 15 and March 1, 2022, using the database of Fayoum University. A self-administered online survey consisting of 80 questions was developed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A COVID-19 survey in electronic or hard copy format for healthcare workers include physicians, nurses, emergency medical personnel, medical and nursing students, and administrative staff. The survey included questions about the respondents' demographic characteristics, changes in their practice during the pandemic period, and basic knowledge of COVID-19. Furthermore, questions evaluating fear and stress associated with the pandemic. In addition, the change in the character of the menstrual cycle and sexual life. The participants will be informed that the survey will be intended for research and that their participation will be anonymous. Participants did not have to answer all the questions in order to complete the survey.
Key inclusion criteria (1 listed)
- All obstetrics and gynecology department healthcare workers who were or had been resident, physicians or consultant physicians, nurses, and paramedical healthcare active during the COVID-19 pandemic period at a designated Fayoum university hospital, regardless of gender, age, experience, and duration of employment.
Key exclusion criteria (3 listed)
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: 6 month after working in the pandemic
Irregular menstrual cycle
Length of cycle
Time frame: 6 month after working in the pandemic
Length of cycle (days)
Rate of prolonged bleeding per cycle
Time frame: 6 month after working in the pandemic
Duration of bleeding (day)
Amount of flow
Time frame: 6 month after working in the pandemic
Number of used tampons (pads) during bleeding
Rate of dysmenorrhea
Time frame: 6 month after working in the pandemic
Dysmenorrhea status
Recognizing the stress related to work in the Covid-19 pandemic
Time frame: 6 month after working in the pandemic
The person is asked to answer the questions on the scale over the symptoms she has experienced during the past year including today'. Each item scores between 0 and 3 as none, mild, moderate, and severe, respectively.
Recognizing a change in sexual life
Time frame: 6 month after working in the pandemic
The participants will answer the survey by yes or no.
3 secondary outcomes
The number of differences in menstrual cycle length
Time frame: 6 month after working in the pandemic
The number of differences in bleeding days
Time frame: 6 month after working in the pandemic
The number of differences in the amount of flow
Time frame: 6 month after working in the pandemic
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: No
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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.
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 Stress Related Disorder, run by Fayoum University at 1 site in Egypt.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 May 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rehab A aboshama, Ass Professor (01156608221 ext. +2, ras07@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of irregular menstrual cycle (time frame: 6 month after working in the pandemic). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2023.