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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by University Hospital, Tours.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00246766
First received: October 28, 2005
Last updated: November 21, 2007
Last verified: November 2007
  Purpose

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
Pregnancy
Fetal Distress

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Qualitative and Quantitative Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy

Further study details as provided by University Hospital, Tours:

Estimated Enrollment: 90
Study Start Date: March 2005
Estimated Study Completion Date: June 2010
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00246766     History of Changes
Other Study ID Numbers: CT04/ACTIFOETUS
Study First Received: October 28, 2005
Last Updated: November 21, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:
Maternal's movements recorded by a specific sensor
Parameters of fetal distress (umbilical and cerebral Doppler) and new-born parameters.

Additional relevant MeSH terms:
Fetal Distress
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014