Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513942
Status:
COMPLETED
Last Update Posted:
2014-10-20
First Post:
2007-08-08
Brief Title:
Effects of Fetal Movement Counting in Third Trimester of Pregnancy
Sponsor:
Norwegian Institute of Public Health
Organization:
Norwegian Institute of Public Health
Study Overview
Official Title:
Effects of Fetal Movement Counting - a Randomized Controlled Trial of an Unselected Population
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim is to test effects of using formal kick counting chart in the third trimester of pregnancy in an unselected population The research questions are
Does Fetal Movement Counting FMC
1 Improve the identification of risk pregnanciespathology
2 Affect the womens well-being
3 Stimulate maternal-fetal attachment antepartum
Does Fetal Movement Counting FMC
1 Improve the identification of risk pregnanciespathology
2 Affect the womens well-being
3 Stimulate maternal-fetal attachment antepartum
Detailed Description:
Fetal activity serves as an indirect measure of central nervous system integrity and function and regular FM can be regarded as an expression of fetal well-beingA hypoxic fetus responds automatically by redistributing blood away from the non-essential organs which lead to a reduction of non-vital activities movements Conversely pregnancies in which the mother report decreased fetal movements DFM is associated with adverse outcomes and may indicate danger for the fetus In cases were DFM are associated with complications of pregnancy maternal lack of sensitivity and awareness to fetal movements may be a risk factor for her pregnancy The most important current identifier of DFM is the womens perception of what is a decrease of FM Fetal movement counting may be a tool for the mothers that might increase identification of risk pregnancies
The outcome measures are referring to the research questions above
1 Identification of risk pregnanciespathology
1 Primary outcome measures Numbers of identified pathological conditions in pregnancies fetal growth restriction FGR acute caesarean section on fetal indicationnon-reactive non-stress test NST oligohydramnios pathologic blood flow in arteria umbilicalis maternal perception of absent fetal movements for more than 24 hours before admission to hospital or perinatal death
2 Secondary outcome measures Frequency of consultations because of maternal concern use of resources in evaluation of these pregnancies NST ultrasound Doppler recurrent consultations induced or spontaneous start of delivery mode of birth
2 Affect the womens well-being
1 Primary outcome measure Maternal concern
2 Secondary outcome measure Maternal satisfaction with use of FMC and sense of control in interpretation of signals from own body and child
3 Stimulate maternal-fetal attachment antepartum
1 Primary outcome measure Maternal-fetal attachment
2 Secondary outcome measure Health promoting behavior in pregnancy smoking habits use of alcohol attending standard program for antenatal care
The outcome measures are referring to the research questions above
1 Identification of risk pregnanciespathology
1 Primary outcome measures Numbers of identified pathological conditions in pregnancies fetal growth restriction FGR acute caesarean section on fetal indicationnon-reactive non-stress test NST oligohydramnios pathologic blood flow in arteria umbilicalis maternal perception of absent fetal movements for more than 24 hours before admission to hospital or perinatal death
2 Secondary outcome measures Frequency of consultations because of maternal concern use of resources in evaluation of these pregnancies NST ultrasound Doppler recurrent consultations induced or spontaneous start of delivery mode of birth
2 Affect the womens well-being
1 Primary outcome measure Maternal concern
2 Secondary outcome measure Maternal satisfaction with use of FMC and sense of control in interpretation of signals from own body and child
3 Stimulate maternal-fetal attachment antepartum
1 Primary outcome measure Maternal-fetal attachment
2 Secondary outcome measure Health promoting behavior in pregnancy smoking habits use of alcohol attending standard program for antenatal care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None