Clinical trial NCT00513942: Effects of Fetal Movement Counting in Third Trimester of Pregnancy
Official title: Effects of Fetal Movement Counting - a Randomized Controlled Trial of an Unselected Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decreased Fetal Movements, Unspecified Trimester, Other Fetus
Worries
Pregnancy
Keywords: Fetal Movement
Maternal-Fetal-Attachment
Fetus
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
First posted: 2007-08-09
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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?

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-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).

Eligibility criteria: 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

Primary outcomes:
measure: Identification of pathological conditions in pregnancies and birth, maternal concern (Cambridge Worry Scale), maternal-fetal attachment (Prenatal Attachment Inventory)
timeFrame: One and a half year
Secondary outcomes:
measure: 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
timeFrame: One and a half year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian Institute of Public Health
Study officials:
affiliation: Norwegian Institute of Public Health
name: Frederik Froen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo and Akershus University College
name: Eli Saastad, CNM, MSc
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.