Effects of Fetal Movement Counting in Third Trimester of Pregnancy

Study Overview
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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): Improve the identification of risk pregnancies/pathology? Affect the women's well-being? 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): 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).

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

Conditions
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Decreased Fetal Movements, Unspecified Trimester, Other Fetus, Worries, Pregnancy

Intervention / Treatment
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* Other: Fetal Movement Counting


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A<br>These women will follow standard antenatal care according to the Norwegian Guidelines | |
| Active Comparator: B<br>Intervention group for Fetal Movement Counting | Other: Fetal Movement Counting<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fetal Movement, Maternal-Fetal-Attachment, Fetus