Effects of Fetal Movement Counting in Third Trimester of Pregnancy
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|ClinicalTrials.gov Identifier: NCT00513942|
Recruitment Status : Completed
First Posted : August 9, 2007
Last Update Posted : October 20, 2014
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?
|Condition or disease||Intervention/treatment||Phase|
|Decreased Fetal Movements, Unspecified Trimester, Other Fetus Worries Pregnancy||Other: Fetal Movement Counting||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Fetal Movement Counting - a Randomized Controlled Trial of an Unselected Population|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||September 2010|
No Intervention: A
These women will follow standard antenatal care according to the Norwegian Guidelines
Active Comparator: B
Intervention group for Fetal Movement Counting
Other: 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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00513942
|Norwegian Institute of Public Health|
|Oslo, Norway, NO-0403|
|Principal Investigator:||Frederik Froen, MD, PhD||Norwegian Institute of Public Health|
|Study Chair:||Eli Saastad, CNM, MSc||University Hospital, Akershus|