Impact of COVID-19 Pandemic on Early Spontaneous Abortions and Early Termination of Pregnancy

Covid19 Clinical Trial

Official title:

Impact of COVID-19 Pandemic on Early Spontaneous Abortions and Early Termination of Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04910958
• Other study ID #: 0199-20-HYMC
• Status: Completed
• Start date: January 6, 2021
• Est. completion date: August 9, 2022

Study information

• Verified date: December 2022
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To see the impact the COVID-19 pandemic has had on early spontaneous abortions and early termination of pregnancy in the first trimester

Description:

To date, the research has focused on the complications of SARS-CoV-2 in pregnant women. There is no research in the literature that has compared the rates and behavior of miscarriage during the time of the COVID-19 pandemic to before the time of the pandemic. As described in the literature, there is an established connection between COVID-19 and stress, anxiety, and depression. There is also an established connection between stress, anxiety, and depression and rates of miscarriage. The investigators hereby wish to analyze the effect of the COVID-19 pandemic on miscarriages.

In this study, The investigators will analyze the number of early missed abortions and number of termination of pregnancies in the first trimester before and during the COVID-19 pandemic. The investigators will also analyze the time interval between diagnosis of missed abortion and attendance to E.R in missed abortions during the COVID-19 pandemic. In addition, The investigators will be comparing the reasons for termination of pregnancy during this time, as well as analyzing age, religion, and demographic variables during the COVID-19 pandemic compared to years prior.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: August 9, 2022
• Est. primary completion date: August 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

Inclusion Criteria:

• All women attending for early missed abortion or termination of pregnancy receiving treatment between March 11th - November 30th during the years 2017-2020 Gestational age until 12 weeks 6 days (1st trimester only)

Exclusion Criteria:

• Incomplete and complete abortions

• Gestational age >13 weeks

Related Conditions & MeSH terms

• Abortion, Spontaneous
• COVID-19
• Covid19
• Pregnancy Loss
• Termination of Pregnancy

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of early missed abortions	Number of early missed abortions in the first trimester in COVID19 time compared to years prior	Two years
Primary	Number of termination of pregnancies	Number of termination of pregnancies in the first trimester in COVID19 time compared to years prior	Two years
Secondary	Time between discovery and attendance	Time between discovery and attendance in missed abortions during COVID19 time compared to years prior	1 year
Secondary	Comparison of reasons for termination	Comparison of reasons for termination of pregnancy during COVID19 time compared to years prior	1 year
Secondary	Comparison of Age/Religion/Demographic variables	Comparison of Age/Religion/Demographic variables of termination of pregnancy during COVID19 time compared to years prior	1 year