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| Sponsor: | University Hospital, Tours |
|---|---|
| Information provided by: | University Hospital, Tours |
| ClinicalTrials.gov Identifier: | NCT00246766 |
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: | Prospective |
| Official Title: | Qualitative and Quantitative Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy |
| Estimated Enrollment: | 90 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | June 2010 |
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:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Pregnant women
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: François TRANQUART, PR | (33) 2 47 47 38 48 | tranquart@med.univ-tours.fr |
| 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 | |
| Principal Investigator: | François TRANQUART, PR | Centre d'Innovation Technologique - CHRU de TOURS |
More Information
| Study ID Numbers: | CT04/ACTIFOETUS |
| Study First Received: | October 28, 2005 |
| Last Updated: | November 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00246766 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
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Maternal's movements recorded by a specific sensor Parameters of fetal distress (umbilical and cerebral Doppler) and new-born parameters. |
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Signs and Symptoms Fetal Distress |