Effects of Fetal Movement Counting in Third Trimester of Pregnancy
NCT ID: NCT00513942
Last Updated: 2014-10-20
Study Results
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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COMPLETED
NA
1200 participants
INTERVENTIONAL
2007-08-31
2010-09-30
Brief Summary
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Does Fetal Movement Counting (FMC):
1. Improve the identification of risk pregnancies/pathology?
2. Affect the women's well-being?
3. Stimulate maternal-fetal attachment antepartum?
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Detailed Description
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The outcome measures are (referring to the research questions above):
1. Identification of risk pregnancies/pathology?
1. Primary outcome measures: Numbers of identified pathological conditions in pregnancies (fetal growth restriction (FGR), acute caesarean section on fetal indication/non-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 women's 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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A
These women will follow standard antenatal care according to the Norwegian Guidelines
No interventions assigned to this group
B
Intervention group for Fetal Movement Counting
Fetal Movement Counting
Women in the intervention group will receive an information pamphlet. The main items will be basic information and interpretation of fetal activity and instructions when to contact health professionals if experiencing DFM.
Interventions
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Fetal Movement Counting
Women in the intervention group will receive an information pamphlet. The main items will be basic information and interpretation of fetal activity and instructions when to contact health professionals if experiencing DFM.
Eligibility Criteria
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Inclusion Criteria
* native speaking women
* singleton pregnancies
Exclusion Criteria
16 Years
FEMALE
No
Sponsors
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Norwegian Institute of Public Health
OTHER_GOV
Responsible Party
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Frederik Froen
Head of Department
Principal Investigators
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Frederik Froen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Norwegian Institute of Public Health
Eli Saastad, CNM, MSc
Role: STUDY_CHAIR
Oslo and Akershus University College
Locations
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Norwegian Institute of Public Health
Oslo, , Norway
Countries
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References
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Saastad E, Winje BA, Stray Pedersen B, Froen JF. Fetal movement counting improved identification of fetal growth restriction and perinatal outcomes--a multi-centre, randomized, controlled trial. PLoS One. 2011;6(12):e28482. doi: 10.1371/journal.pone.0028482. Epub 2011 Dec 21.
Winje BA, Saastad E, Gunnes N, Tveit JV, Stray-Pedersen B, Flenady V, Froen JF. Analysis of 'count-to-ten' fetal movement charts: a prospective cohort study. BJOG. 2011 Sep;118(10):1229-38. doi: 10.1111/j.1471-0528.2011.02993.x. Epub 2011 May 18.
Other Identifiers
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NIPH-EPAM-335
Identifier Type: -
Identifier Source: org_study_id
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