NCT05551078

Brief Summary

This retrospective study aims to assess the input of thrombophilia screening in pregnant women with severe intra-uterine growth restricted babies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 15, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

16 days

First QC Date

September 20, 2022

Last Update Submit

September 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of positive's thrombophilia screening

    5 years

Study Arms (1)

pregnant women with severe IUGR

Biological: thrombophilia screening

Interventions

In the IUGR group systematic thrombophilia screening had already been performed.

pregnant women with severe IUGR

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Women over 18 years old * Pregnant women * IUGR defined by an EFW \<3rd centile * IUGR before 25 GW

You may qualify if:

  • Women over 18 years old
  • Pregnant women
  • IUGR defined by an EFW \<3rd centile
  • IUGR before 25 GW

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Matthieu Dap

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

ThrombophiliaPregnancy Complications

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

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

Study Record Dates

First Submitted

September 20, 2022

First Posted

September 22, 2022

Study Start

September 15, 2022

Primary Completion

October 1, 2022

Study Completion

January 1, 2023

Last Updated

September 22, 2022

Record last verified: 2022-09

Locations