Effects of Fetal Movement Counting in Third Trimester of Pregnancy
1 other identifier
interventional
1,200
1 country
1
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 pregnancies/pathology?
- 2.Affect the women's well-being?
- 3.Stimulate maternal-fetal attachment antepartum?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 8, 2007
CompletedFirst Posted
Study publicly available on registry
August 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedOctober 20, 2014
October 1, 2014
2.8 years
August 8, 2007
October 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identification of pathological conditions in pregnancies and birth, maternal concern (Cambridge Worry Scale), maternal-fetal attachment (Prenatal Attachment Inventory)
One and a half year
Secondary Outcomes (1)
Frequency of consultations, use of resources and mode of birth, maternal satisfaction and sense of control in interpretation of signals from own body and child, health promoting behavior
One and a half year
Study Arms (2)
A
NO INTERVENTIONThese women will follow standard antenatal care according to the Norwegian Guidelines
B
ACTIVE COMPARATORIntervention group for Fetal Movement Counting
Interventions
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
You may qualify if:
- women booking at screening ultrasound in pregnancy week 17-20
- native speaking women
- singleton pregnancies
You may not qualify if:
- women with pregnancies with severe anomalies or other cause to consider termination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Norwegian Institute of Public Health
Oslo, NO-0403, Norway
Related Publications (2)
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.
PMID: 22205952DERIVEDWinje 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.
PMID: 21585644DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Frederik Froen, MD, PhD
Norwegian Institute of Public Health
- STUDY CHAIR
Eli Saastad, CNM, MSc
Oslo and Akershus University College
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department
Study Record Dates
First Submitted
August 8, 2007
First Posted
August 9, 2007
Study Start
August 1, 2007
Primary Completion
May 1, 2010
Study Completion
September 1, 2010
Last Updated
October 20, 2014
Record last verified: 2014-10