PregnancyNCT00246766
Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy
An observational study of Pregnancy and Fetal Distress, run by University Hospital, Tours at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Fetal Distress
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2005to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women
Who may be able to join
- 18 years of age or older
- Pregnancy with singleton
- Woman from 28 weeks of amenorrhea
Who cannot join
- Fetal malformation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of TOURS
Tours, 37044
François TRANQUART, PR, (33) 2 47 47 38 48, tranquart@med.univ-tours.fr
Franck PERROTIN, PR
About this study
Official title: Qualitative and Quantitative Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy
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.
Read the 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
- 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.
- Medical subject headings
- Fetal Distress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study startMar 2005
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Investigators
- François TRANQUART, PR, Principal investigator, Centre d'Innovation Technologique - CHRU de TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246766
- Sponsor's protocol ID
- CT04/ACTIFOETUS
- Status last verified
- Nov 2007
- First submitted
- 28 Oct 2005
- Last updated
- 22 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 5699016Karlsson 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.
PubMed 10717514Melendez 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.
PubMed 1530026Timor-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.
PubMed 961750Shinozuka 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.
PubMed 8231327Manning FA. Fetal biophysical profile. Obstet Gynecol Clin North Am. 1999 Dec;26(4):557-77, v. doi: 10.1016/s0889-8545(05)70099-1.
PubMed 10587955
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative and Quantitative Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy
- ClinicalTrials.gov ID
- NCT00246766
- Acronym / sponsor ID
- CT04/ACTIFOETUS
- 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.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- Jun 2010 (estimated)
- First posted
- 31 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (3 listed)
- 18 years of age or older
- Pregnancy with singleton
- Woman from 28 weeks of amenorrhea
Key exclusion criteria (1 listed)
- Fetal malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2007.
- Background: PubMed 5699016Hammacher 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.
- Background: PubMed 10717514Karlsson 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.
- Background: PubMed 1530026Melendez 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.
- Background: PubMed 961750Timor-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.
- Background: PubMed 8231327Shinozuka 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.
- Background: PubMed 10587955Manning FA. Fetal biophysical profile. Obstet Gynecol Clin North Am. 1999 Dec;26(4):557-77, v. doi: 10.1016/s0889-8545(05)70099-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François TRANQUART, PR principal investigator
Centre d'Innovation Technologique - CHRU de TOURS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Fetal Distress, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François TRANQUART, PR ((33) 2 47 47 38 48, tranquart@med.univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00246766, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2007.