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

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ClinicalTrials.gov Identifier: NCT00246766
Recruitment Status : Unknown
Verified November 2007 by University Hospital, Tours.
Recruitment status was:  Recruiting
First Posted : October 31, 2005
Last Update Posted : November 22, 2007
Sponsor:
Information provided by:
University Hospital, Tours

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
Pregnancy Fetal Distress

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 Type : Observational
Estimated 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 : March 2005
Estimated Study Completion Date : June 2010




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Pregnancy with singleton
  • Woman from 28 weeks of amenorrhea

Exclusion Criteria:

  • Fetal malformation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246766


Contacts
Contact: François TRANQUART, PR (33) 2 47 47 38 48 tranquart@med.univ-tours.fr

Locations
France
University Hospital of TOURS Recruiting
Tours, France, 37044
Contact: François TRANQUART, PR    (33) 2 47 47 38 48    tranquart@med.univ-tours.fr   
Sub-Investigator: Franck PERROTIN, PR         
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: François TRANQUART, PR Centre d'Innovation Technologique - CHRU de TOURS