Clinical trial NCT00246766: Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy
Official title: Qualitative and Quantitative Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Fetal Distress
Keywords: Maternal's movements recorded by a specific sensor
Parameters of fetal distress (umbilical and cerebral Doppler) and new-born parameters.
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2005-10-30
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Fetal malformation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital of TOURS
Study officials:
affiliation: Centre d'Innovation Technologique - CHRU de TOURS
name: François TRANQUART, PR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hammacher K, Huter KA, Bokelmann J, Werners PH. Foetal heart frequency and perinatal condition of the foetus and newborn. Gynaecologia. 1968;166(4):349-60. doi: 10.1159/000302346. No abstract available.
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. doi: 10.1016/s0929-8266(99)00071-3.
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. doi: 10.1016/s0002-9378(11)91574-9.
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. doi: 10.1016/0002-9378(76)90467-1.
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. doi: 10.1007/BF02446651.
citation: Manning FA. Fetal biophysical profile. Obstet Gynecol Clin North Am. 1999 Dec;26(4):557-77, v. doi: 10.1016/s0889-8545(05)70099-1.