Effects of Fetal Movement Counting in Third Trimester of Pregnancy

NCT ID: NCT00513942

Last Updated: 2014-10-20

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-09-30

Brief Summary

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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?

Detailed Description

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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-being.A 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 women's 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 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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Decreased Fetal Movements, Unspecified Trimester, Other Fetus Worries Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A

These women will follow standard antenatal care according to the Norwegian Guidelines

Group Type NO_INTERVENTION

No interventions assigned to this group

B

Intervention group for Fetal Movement Counting

Group Type ACTIVE_COMPARATOR

Fetal Movement Counting

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* women booking at screening ultrasound in pregnancy week 17-20
* native speaking women
* singleton pregnancies

Exclusion Criteria

* women with pregnancies with severe anomalies or other cause to consider termination
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Frederik Froen

Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Norway

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.

Reference Type DERIVED
PMID: 22205952 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21585644 (View on PubMed)

Other Identifiers

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NIPH-EPAM-335

Identifier Type: -

Identifier Source: org_study_id

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