Termination of PregnancyNCT04910958
Impact of COVID-19 Pandemic on Early Spontaneous Abortions and Early Termination of Pregnancy
An observational study of Termination of Pregnancy and Covid19, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Termination of Pregnancy, Covid19, Pregnancy Loss
- How many people
- 411 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Jan 2021to 9 Aug 2022
- 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: 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)
Who may be able to join
- 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)
Who cannot join
- Incomplete and complete abortions
- Gestational age >13 weeks
Trial locations and contacts
1 site in 1 country.
About this study
To see the impact the COVID-19 pandemic has had on early spontaneous abortions and early termination of pregnancy in the first trimester
Read the detailed 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.
- Conditions
- Termination of Pregnancy, Covid19, Pregnancy Loss
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of early missed abortions
Number of early missed abortions in the first trimester in COVID19 time compared to years prior
Measured: Two years
Number of termination of pregnancies
Number of termination of pregnancies in the first trimester in COVID19 time compared to years prior
Measured: Two years
Secondary outcomes (3)
Time between discovery and attendance
Time between discovery and attendance in missed abortions during COVID19 time compared to years prior
Measured: 1 year
Comparison of reasons for termination
Comparison of reasons for termination of pregnancy during COVID19 time compared to years prior
Measured: 1 year
Comparison of Age/Religion/Demographic variables
Comparison of Age/Religion/Demographic variables of termination of pregnancy during COVID19 time compared to years prior
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start6 Jan 2021
- Primary completion9 Aug 2022
- Study completion9 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Termination of PregnancyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Omer Mor, MD, Principal investigator, omer.moore@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910958
- Sponsor's protocol ID
- 0199-20-HYMC
- Status last verified
- Dec 2022
- First submitted
- 1 Jun 2021
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 Pandemic on Early Spontaneous Abortions and Early Termination of Pregnancy
- ClinicalTrials.gov ID
- NCT04910958
- Acronym / sponsor ID
- 0199-20-HYMC
- Conditions
- Termination of Pregnancy, Covid19, Pregnancy Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 9 Aug 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 2 Jun 2021 (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.
To see the impact the COVID-19 pandemic has had on early spontaneous abortions and early termination of pregnancy in the first trimester
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 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)
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- Incomplete and complete abortions
- Gestational age >13 weeks
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
Number of early missed abortions
Time frame: Two years
Number of early missed abortions in the first trimester in COVID19 time compared to years prior
Number of termination of pregnancies
Time frame: Two years
Number of termination of pregnancies in the first trimester in COVID19 time compared to years prior
3 secondary outcomes
Time between discovery and attendance
Time frame: 1 year
Comparison of reasons for termination
Time frame: 1 year
Comparison of Age/Religion/Demographic variables
Time frame: 1 year
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 6 Dec 2022.
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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.
Omer Mor, MD principal investigator
omer.moore@gmail.com
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 Termination of Pregnancy and Covid19, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 2 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 6 Dec 2022. 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 Israel. 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?
Number of early missed abortions (time frame: Two years). The study lists 2 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 6 Dec 2022.