Decreased Fetal Movements, Unspecified Trimester, Other FetusNCT00513942
Effects of Fetal Movement Counting in Third Trimester of Pregnancy
A study testing Fetal Movement Counting in people with Decreased Fetal Movements, Unspecified Trimester, Other Fetus and Worries, run by Norwegian Institute of Public Health at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Decreased Fetal Movements, Unspecified Trimester, Other Fetus, Worries, Pregnancy
- What is being tested?
- Fetal Movement Counting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2007to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- women booking at screening ultrasound in pregnancy week 17-20
- native speaking women
- singleton pregnancies
Who cannot join
- women with pregnancies with severe anomalies or other cause to consider termination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Fetal Movement Counting - a Randomized Controlled Trial of an Unselected Population
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?
Read the 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).
- Being tested
- Fetal Movement Counting
- Keywords
- Fetal Movement, Maternal-Fetal-Attachment, Fetus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Movement CountingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | These women will follow standard antenatal care according to the Norwegian Guidelines |
| B | Active comparator | Intervention group for Fetal Movement Counting Receives: Other: Fetal Movement Counting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of pathological conditions in pregnancies and birth, maternal concern (Cambridge Worry Scale), maternal-fetal attachment (Prenatal Attachment Inventory)
Measured: One and a half year
Secondary outcomes (1)
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
Measured: One and a half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionMay 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Decreased Fetal Movements, Unspecified Trimester, Other FetusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Frederik Froen, Norwegian Institute of Public Health
- Investigators
- Frederik Froen, MD, PhD, Principal investigator, Norwegian Institute of Public HealthEli Saastad, CNM, MSc, Study chair, Oslo and Akershus University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513942
- Sponsor's protocol ID
- NIPH-EPAM-335
- Status last verified
- Oct 2014
- First submitted
- 8 Aug 2007
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Saastad E, Winje BA, Stray Pedersen B, Froen JF. Fetal movement counting improved identification of fetal growth restriction and perinatal outcomes--a multi-centre, randomized, controlled trial. PLoS One. 2011;6(12):e28482. doi: 10.1371/journal.pone.0028482. Epub 2011 Dec 21.
PubMed 22205952Winje BA, Saastad E, Gunnes N, Tveit JV, Stray-Pedersen B, Flenady V, Froen JF. Analysis of 'count-to-ten' fetal movement charts: a prospective cohort study. BJOG. 2011 Sep;118(10):1229-38. doi: 10.1111/j.1471-0528.2011.02993.x. Epub 2011 May 18.
PubMed 21585644
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fetal Movement Counting - a Randomized Controlled Trial of an Unselected Population
- ClinicalTrials.gov ID
- NCT00513942
- Acronym / sponsor ID
- NIPH-EPAM-335
- Keywords
- Fetal Movement, Maternal-Fetal-Attachment, Fetus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Study start
- Aug 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –These women will follow standard antenatal care according to the Norwegian Guidelines |
| B | Active comparator | Other: Fetal Movement CountingIntervention group for Fetal Movement Counting |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- women booking at screening ultrasound in pregnancy week 17-20
- native speaking women
- singleton pregnancies
Key exclusion criteria (1 listed)
- women with pregnancies with severe anomalies or other cause to consider termination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal Movement CountingWomen 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 | B |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
- Derived from this study: PubMed 22205952Saastad E, Winje BA, Stray Pedersen B, Froen JF. Fetal movement counting improved identification of fetal growth restriction and perinatal outcomes--a multi-centre, randomized, controlled trial. PLoS One. 2011;6(12):e28482. doi: 10.1371/journal.pone.0028482. Epub 2011 Dec 21.
- Derived from this study: PubMed 21585644Winje BA, Saastad E, Gunnes N, Tveit JV, Stray-Pedersen B, Flenady V, Froen JF. Analysis of 'count-to-ten' fetal movement charts: a prospective cohort study. BJOG. 2011 Sep;118(10):1229-38. doi: 10.1111/j.1471-0528.2011.02993.x. Epub 2011 May 18.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederik Froen, MD, PhD principal investigator
Norwegian Institute of Public Health
Eli Saastad, CNM, MSc study chair
Oslo and Akershus University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal Movement Counting in people with Decreased Fetal Movements, Unspecified Trimester, Other Fetus and Worries, run by Norwegian Institute of Public Health at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00513942, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2014.