NCT04415359

Brief Summary

Because of the physiological changes inherent in pregnancy, pregnant women with lower respiratory tract infections often have more worrisome outcomes compared to non-pregnant individuals, including a higher rate of hospital and intensive care unit admissions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

May 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 1, 2021

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

May 29, 2020

Last Update Submit

March 30, 2021

Conditions

Covid-19

Keywords

COVID-19SARS-CoV-2ARDSICUPregnant womenPregnancyFetusMiddle East Respiratory SyndromeMERSMaternal respiratory impairmentMedical Assisted ProcreationMARFrozen embryos

Outcome Measures

Primary Outcomes (1)

  • Study of the evolution of pregnancies in the first trimester following MAR management during a COVD-19 pandemic period

    12th week of Amenorrhea

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patient included in MAR protocol aged between 18 and 43 years of age who has already signed a consent to management

You may qualify if:

  • Patient included in a Medically Assisted Procreation (MAR) protocol aged between 18 and 43 years of age
  • Patient who has already signed a consent to management

You may not qualify if:

  • Patient who expressed opposition to participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Clinico biologique d'Assistance Médicale à La Procréation

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 4, 2020

Study Start

August 1, 2020

Primary Completion

October 31, 2020

Study Completion

December 31, 2020

Last Updated

April 1, 2021

Record last verified: 2020-05

Locations

FR(1)