Study of Fetal Movements Using Multichannel Ultrasound Pu... | NCT00246766

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

NCT00246766

Sponsor

University Hospital, Tours

Status

Unknown status

Last Update Posted

Nov 22, 2007Estimated

Enrollment

90Estimated

Phase

Not provided

Conditions

Pregnancy
Fetal Distress

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Not provided

Completion Date

Jun 2010Estimated

First Submitted Date

Oct 28, 2005

First Submission Date that Met QC Criteria

Oct 28, 2005

First Posted Date

Oct 31, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2007

Last Update Posted Date

Nov 22, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Fetal malformation

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnant women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
François TRANQUART, PR	Contact	(33) 2 47 47 38 48		tranquart@med.univ-tours.fr

Overall Officials

Name	Affiliation	Role
François TRANQUART, PR	Centre d'Innovation Technologique - CHRU de TOURS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of TOURS	Recruiting	Tours		37044	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
5699016	Background	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.
10717514	Background	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.

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms