COVID-19 Vaccines and the Menstrual Cycle

COVID-19 Vaccines and the Menstrual Cycle; a Cross-sectional Study

The study aimed to explore the effect of different COVID-19 vaccines on menstrual cycle

Study Overview

• Status: Completed
• Conditions: Menstrual Irregularity
• Intervention / Treatment: Biological: Naser Al-Husban

Detailed Description

This is a descriptive cross-sectional study that took place between September 2021 and December 2021. The study aimed to explore the effect of different COVID-19 vaccines on menstrual cycle. It used an anonymous questionnaire distributed via social media platforms; Facebook, Twitter, and WhatsApp across different cities of Jordan. A total of 732 responses were received with a 59% response rate.

The questionnaire was distributed over four months directed at women who have received at least one dose of the COVID-19 vaccine and who live in Jordan. It took 10 minutes to complete all the questions.

Data collection did not involve direct contact with participants to prevent the spread of COVID-19.

• Study Type: Observational
• Enrollment (Actual): 617

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan, 11941
    • Jordan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Our study included 617 Menstruating females. 74.55% of participants were of the age group between 20-35 years. 59.64% had normal BMI (18.5-24.9 Kg/m2), while 11.99% were underweight (BMI less than 18.5 Kg/m2), 19.77% were overweight (BMI>24.9 Kg/m2 but less than 30 Kg/m2), and 8.59% were obese (BMI more than 30 Kg/m2). Largest BMI was 39.79 Kg/m2. Most of participants were single ladies (79.25%). 82.01% were nulliparous. 17.83% were multiparous, including 1.62% ladies that had 5 or more children (grand multiparous).

Description

Inclusion Criteria:

• 18 years and older
• less than 40 years
• healthy women
• received covid-19 vaccine

Exclusion Criteria:

• women who did not receive the vaccine
• those living outside Jordan (those cannot fill the form) and during analysis.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
significant changes in the menstrual cycle after vaccination	changes that involve bleeding amount or pain	6 months

Collaborators and Investigators

• Sponsor: University of Jordan
• Investigators: Principal Investigator: Naser U Al-Husban, The University of Jordan

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances
• Other Study ID Numbers: ju

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: can be shared with reasonable request from the primary investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No