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Effects of Fetal Movement Counting in Third Trimester of Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frederik Froen, Norwegian Institute of Public Health
ClinicalTrials.gov Identifier:
NCT00513942
First received: August 8, 2007
Last updated: October 17, 2014
Last verified: October 2014
  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 (FMC):

  1. Improve the identification of risk pregnancies/pathology?
  2. Affect the women's well-being?
  3. Stimulate maternal-fetal attachment antepartum?

Condition Intervention
Decreased Fetal Movements, Unspecified Trimester, Other Fetus
Worries
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

Further study details as provided by Norwegian Institute of Public Health:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1200
Study Start Date: August 2007
Study Completion Date: September 2010
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):

  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).
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513942

Locations
Norway
Norwegian Institute of Public Health
Oslo, Norway, NO-0403
Sponsors and Collaborators
Norwegian Institute of Public Health
Investigators
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 Froen, Head of Department, Norwegian Institute of Public Health
ClinicalTrials.gov Identifier: NCT00513942     History of Changes
Other Study ID Numbers: NIPH-EPAM-335
Study First Received: August 8, 2007
Last Updated: October 17, 2014
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 November 27, 2014