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

NCT ID: NCT00246766

Last Updated: 2007-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2010-06-30

Brief Summary

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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

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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

Conditions

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Pregnancy Fetal Distress

Keywords

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Maternal's movements recorded by a specific sensor Parameters of fetal distress (umbilical and cerebral Doppler) and new-born parameters.

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Fetal malformation
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Principal Investigators

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François TRANQUART, PR

Role: PRINCIPAL_INVESTIGATOR

Centre d'Innovation Technologique - CHRU de TOURS

Locations

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University Hospital of TOURS

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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François TRANQUART, PR

Role: CONTACT

Phone: (33) 2 47 47 38 48

Email: [email protected]

Facility Contacts

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François TRANQUART, PR

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 5699016 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10717514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1530026 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 961750 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8231327 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10587955 (View on PubMed)

Other Identifiers

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CT04/ACTIFOETUS

Identifier Type: -

Identifier Source: org_study_id