Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy

Sponsor
University Hospital, Tours (Other)
Overall Status
Unknown status
CT.gov ID
NCT00246766
Collaborator
(none)
90
1
63
1.4

Study Details

Study Description

Brief Summary

To enable an investigation of fetal movements, the researchers have developed a multichannel ultrasound pulsed Doppler called ACTIFOETUS. This new fetal monitor includes three transducers of four sensors which are placed on three different zones of the mother's abdomen. One of the transducers is aimed at the fetal heart, another at the lower limbs and one transducer at the thorax and the fetal upper limbs to detect heart and body movements. The signals are analysed and processed by software which computes a number of parameters describing the movements.

Ninety pregnant women from 28 weeks gestation will be monitored over a 40 minute period every month or every 2 weeks in case of pathological pregnancy. The final purpose will be to develop a system of home monitoring as an indicator of fetal well-being.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The main objective of the study is to detect quantitative and qualitative disorders of fetal movements from 28 weeks of amenorrhea on a fetus presenting in fetal distress.

    The fetal rhythm will be recorded during 24 hours and a correlation between maternal and fetal movements will be studied.

    Specific measures:
    • The fetal heart rate

    • The number and extent of fetal movements

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Time Perspective:
    Prospective
    Official Title:
    Qualitative and Quantitative Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy
    Study Start Date :
    Mar 1, 2005
    Anticipated Study Completion Date :
    Jun 1, 2010

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • 18 years of age or older

      • Pregnancy with singleton

      • Woman from 28 weeks of amenorrhea

      Exclusion Criteria:
      • Fetal malformation

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 University Hospital of TOURS Tours France 37044

      Sponsors and Collaborators

      • University Hospital, Tours

      Investigators

      • Principal Investigator: François TRANQUART, PR, Centre d'Innovation Technologique - CHRU de TOURS

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00246766
      Other Study ID Numbers:
      • CT04/ACTIFOETUS
      First Posted:
      Oct 30, 2005
      Last Update Posted:
      Nov 22, 2007
      Last Verified:
      Nov 1, 2007

      Study Results

      No Results Posted as of Nov 22, 2007