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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00246766
• Other study ID #: CT04/ACTIFOETUS
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2005
• Last updated: November 21, 2007
• Start date: March 2005
• Est. completion date: June 2010

Study information

• Verified date: November 2007
• Source: University Hospital, Tours
• Contact: François TRANQUART, PR
• Phone: (33) 2 47 47 38 48
• Email: tranquart[@]med.univ-tours.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Pregnancy with singleton

• Woman from 28 weeks of amenorrhea

Exclusion Criteria:

• Fetal malformation

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Fetal Distress
• Pregnancy

Locations

Country	Name	City	State
France	University Hospital of TOURS	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

References & Publications (6)

Hammacher K, Hüter KA, Bokelmann J, Werners PH. Foetal heart frequency and perinatal condition of the foetus and newborn. Gynaecologia. 1968;166(4):349-60. — View Citation

Karlsson B, Berson M, Helgason T, Geirsson RT, Pourcelot L. Effects of fetal and maternal breathing on the ultrasonic Doppler signal due to fetal heart movement. Eur J Ultrasound. 2000 Mar;11(1):47-52. — View Citation

Manning FA. Fetal biophysical profile. Obstet Gynecol Clin North Am. 1999 Dec;26(4):557-77, v. Review. — View Citation

Melendez TD, Rayburn WF, Smith CV. Characterization of fetal body movement recorded by the Hewlett-Packard M-1350-A fetal monitor. Am J Obstet Gynecol. 1992 Sep;167(3):700-2. — View Citation

Shinozuka N, Yamakoshi Y. Measurement of fetal movements using multichannel ultrasound pulsed Doppler: autorecognition of fetal movements by maximum entropy method. Med Biol Eng Comput. 1993 Jul;31 Suppl:S59-66. — View Citation

Timor-Tritsch I, Zador I, Hertz RH, Rosen MG. Classification of human fetal movement. Am J Obstet Gynecol. 1976 Sep 1;126(1):70-7. — View Citation