Effects of Fetal Movement Counting in Third Trimester of Pregnancy

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513942
• Other study ID #: NIPH-EPAM-335
• Status: Completed
• Phase: N/A
• First received: August 8, 2007
• Last updated: October 17, 2014
• Start date: August 2007
• Est. completion date: September 2010

Study information

• Verified date: October 2014
• Source: Norwegian Institute of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Institute of Public Health
• Study type: Interventional

Clinical Trial 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?

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: September 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Norway	Norwegian Institute of Public Health	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian Institute of Public Health

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of pathological conditions in pregnancies and birth, maternal concern (Cambridge Worry Scale), maternal-fetal attachment (Prenatal Attachment Inventory)		One and a half year	Yes
Secondary	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	Yes