Effects of Fetal Movement Counting in Third Trimester of Pregnancy
Recruitment status was Active, not recruiting
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Purpose
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:
- Improve the identification of risk pregnancies/pathology?
- Affect the women's well-being?
- Stimulate maternal-fetal attachment antepartum?
| Condition | Intervention |
|---|---|
|
Fetal Movement Worry Pregnancy |
Other: Fetal Movement Counting |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Effects of Fetal Movement Counting - a Randomized Controlled Trial of an Unselected Population |
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1200 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
Other Name: Fetal movement counting
|
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):
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).
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Norway | |
| 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 | Akershus University College |
More Information
No publications provided by Norwegian Institute of Public Health
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Frederik Frøen, Department Director |
| ClinicalTrials.gov Identifier: | NCT00513942 History of Changes |
| Other Study ID Numbers: | NIPH-EPAM-335 |
| Study First Received: | August 8, 2007 |
| Last Updated: | March 2, 2010 |
| Health Authority: | Norway: Norwegian Institute of Public Health |
Keywords provided by Norwegian Institute of Public Health:
|
Fetal Movement Maternal-Fetal-Attachment Fetus |
ClinicalTrials.gov processed this record on May 23, 2013