NCT04910958

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2022

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

1.6 years

First QC Date

June 1, 2021

Last Update Submit

December 5, 2022

Conditions

Termination of PregnancyCovid19Pregnancy Loss

Outcome Measures

Primary Outcomes (2)

  • Number of early missed abortions

    Number of early missed abortions in the first trimester in COVID19 time compared to years prior

    Two years

  • Number of termination of pregnancies

    Number of termination of pregnancies in the first trimester in COVID19 time compared to years prior

    Two years

Secondary Outcomes (3)

  • Time between discovery and attendance

    1 year

  • Comparison of reasons for termination

    1 year

  • Comparison of Age/Religion/Demographic variables

    1 year

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales only
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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)

You may qualify if:

  • 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)

You may not qualify if:

  • Incomplete and complete abortions
  • Gestational age \>13 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, Israel

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Omer Mor, MD

    omer.moore@gmail.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 2, 2021

Study Start

January 6, 2021

Primary Completion

August 9, 2022

Study Completion

August 9, 2022

Last Updated

December 6, 2022

Record last verified: 2022-12

Locations

IL(1)