Evaluation of the Safety and Performance of Centaflow

Last updated: June 9, 2022
Sponsor: Centaflow
Overall Status: Active - Recruiting

Phase

N/A

Condition

Birth Defects

Treatment

N/A

Clinical Study ID

NCT04438668
2019-01
  • Ages 18-60
  • Female
  • Accepts Healthy Volunteers

Study Summary

The aim of this study is to evaluate the safety and performance of an acoustic approach based on skin-contact microphones as a routine assessment of placental vascular function as predictor of fetal growth restriction.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Female subjects over the age of 18 years.

  • Subejct is pregnant, carries only one fetus and has been pregnancy dated by ultrasound scan (Hadlock reference).

Exclusion Criteria

  • Fetal abnormality known to affect growth, diagnosed in-utero or through 12 days postnatally.

Study Design

Total Participants: 1704
Study Start date:
June 03, 2020
Estimated Completion Date:
June 30, 2022

Study Description

Evaluation of the safety and performance of Centaflow as routine antenatal assessment of placental vascular function as predictor of fetal growth restriction is performed by randomizing singleton pregnant women with ultrasound-based gestations for either standard care (SC) or SC and Centaflow (CF).

The subjects will be randomized in ratio 1:1 in both groups and examined in pregnancy weeks 27-29, 34-36 and 37-39.

Connect with a study center

  • Juliane Marie Centeret, Rigshospitalet

    Copenhagen, 2100
    Denmark

    Active - Recruiting

  • Obstetrical Department, Regional Hospital Viborg

    Viborg, 8800
    Denmark

    Active - Recruiting

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