Effects of Fetal Movement Counting in Third Trimester of Pregnancy

Norwegian Institute of Public Health

Status: Completed

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

Treatments: Other: Fetal Movement Counting

Study type: Interventional

Funder types: Other

Identifiers

NCT00513942

NIPH-EPAM-335

Details and patient eligibility

About

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?

Full 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).

Enrollment: 1,200 patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

A

No Intervention group

Description:

These women will follow standard antenatal care according to the Norwegian Guidelines

B

Active Comparator group

Description:

Intervention group for Fetal Movement Counting

Treatment:

Other: Fetal Movement Counting