NCT04170660

Brief Summary

In patients with suspected placental vascular disease who do not require hospitalization, the use of the sFlt-1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor)/ assay can most likely help teams to define the best possible management.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 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

First Submitted

Initial submission to the registry

November 15, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

November 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

4 years

First QC Date

November 15, 2019

Last Update Submit

June 6, 2023

Conditions

Suspected Placental Dysfunction, Ruled OutPregnancy ComplicationsPre-Eclampsia

Outcome Measures

Primary Outcomes (1)

  • Reconvening period in patients with an sFlt1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor) ratio <38 (day)

    At the end of pregnancy, calculation of the average time between the 1st consultation and the 1st reconvening in patients with an sFlt1/PlGF ratio \<38, unknown during pregnancy, to determine if consultations could have been avoided.

    trough participation period, an average of 4 months

Secondary Outcomes (11)

  • reconvening period in patients with an sFlt1/PlGF ratio between 38 and 85 (day)

    trough participation period, an average of 4 months

  • reconvening period in patients with an sFlt1/PlGF ratio superior to 85 (day)

    trough participation period, an average of 4 months

  • blood pressure (mmHg)

    trough participation period, an average of 4 months

  • number of patients with functional signs of hypertension

    trough participation period, an average of 4 months

  • number of patient with abnormal vascular and renal blood tests

    trough participation period, an average of 4 months

  • +6 more secondary outcomes

Interventions

Diagnostic testDIAGNOSTIC_TEST

During a vascular check-up usually prescribed, an additional blood sample is taken to allow the determination of the sFlt1/PlGf ratio.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pregnant women suspected of placental vascular disease

You may qualify if:

  • Age ≥ 18 years old
  • Pregnant patients term ≥ at 24 weeks of amenorrhoea (SA),
  • Management in obstetrical emergencies and at the Centre Hopsitalier Intercommunal (CHI) de Créteil functional exploration center, with prescription of a vascular-renal check-up (BVR) ((proteinuria/creatinuria ratio, blood count, platelets, blood ionogram, creatinemia, transaminases (ASAT, ALAT), haptoglobulinemia, lactate dehydrogenase (LDH), TP).
  • Presenting either one of the following isolated or associated clinical parameters:
  • HyperTension
  • urinary tape proteinuria
  • functional signs of hypertension (headaches, phosphenes, accouphènes)
  • live osteotendinous reflexes
  • epigastric pains
  • weight gain, lower limb edema, facial edema
  • oliguria
  • vomiting
  • or one of the following isolated or associated ultrasound parameters:
  • fetal hypotrophy, fetal growth deflection
  • fetal Doppler abnormalities (umbilical Doppler, cerebral Doppler)
  • +2 more criteria

You may not qualify if:

  • Diagnosis of preeclampsia
  • Refusal of the patient
  • Patient whose symptomatology (clinical or paraclinical) leads to a decision to be hospitalized
  • Age \< 18 years old
  • Non-affiliation to the general social security system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Intercommunal de Créteil

Créteil, 94000, France

Location

MeSH Terms

Conditions

Pregnancy ComplicationsPre-Eclampsia

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertension, Pregnancy-Induced

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

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

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 20, 2019

Study Start

November 18, 2019

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

June 7, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)