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Completed

NCT Number: NCT00513942

Effects of Fetal Movement Counting in Third Trimester of Pregnancy

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?

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Key information

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian Institute of Public Health

Oslo, NO-0403, Norway

About this study

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):

  • Identification of risk pregnancies/pathology?
  • 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).
  • 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.
  • Affect the women's well-being?
  • Primary outcome measure: Maternal concern.
  • Secondary outcome measure: Maternal satisfaction with use of FMC and sense of control in interpretation of signals from own body and child.
  • Stimulate maternal-fetal attachment antepartum?
  • Primary outcome measure: Maternal-fetal attachment.
  • Secondary outcome measure: Health promoting behavior in pregnancy (smoking habits, use of alcohol, attending standard program for antenatal care).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fetal Movement Counting

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.

Primary outcomes

  1. Identification of pathological conditions in pregnancies and birth, maternal concern (Cambridge Worry Scale), maternal-fetal attachment (Prenatal Attachment Inventory)

    Time frame: 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

    Time frame: One and a half year

Sponsors and collaborators

Lead sponsor

Norwegian Institute of Public Health

Other Gov

Registry information

Official study title

Effects of Fetal Movement Counting - a Randomized Controlled Trial of an Unselected Population

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 9, 2007
Registry last updated
Oct 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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