- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02979834
When Will I Feel The First Movements of My Baby? (FFM)
November 29, 2016 updated by: Hatice Akkaya, Kayseri Education and Research Hospital
A Frequently Asked Question: When Will I Feel The First Movements of My Baby?
This study aims to investigate average gestational week in which mothers feel the babies'movements for the first time and maternal-fetal factors affecting this time.
Study Overview
Status
Completed
Conditions
Detailed Description
Most of the obstetricians face the question; "When Will I Feel The First Movements of My Baby?", in daily practice.
It becomes a challenge for the obstetrician to answer this question.
Because, there is not a sufficient data in the current literature on this issue.
A broad range of weeks for fetal quickening are reported as 16th to 20th weeks, in round figures.
So, when a woman in the 21st gestational week , asks this question to the obstetrician and informed according to aforementioned literature knowledge, the woman will ask another question immediately after: "What is the problem with my baby?".
But, the obstetrician will not be able to give an assuring answer because of the lack of knowledge in the current literature.Thus, to cope with such a clinical situation, the investigators decided to investigate the average week in which pregnant women in a low risk population, felt the babies' movements for the first time and to find out the affects of probable factors which may act on this time.
Study Type
Observational
Enrollment (Actual)
423
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Three groups were formed according to the gestational week in which fetal movements felt by mother for the first time.
25th percentile, 50thand 75th percentile values were determined .Participants who felt the babies' movements at or before 25th percentile value constituted Group1 or early perception group, participants who felt the babies' movements between 25th and 75th percentile value constituted Group 2 or average perception group and the participants who felt the babies'movements at or beyond 75th value constituted Group 3 or late perception group.
Subsequently, these three groups were compared regarding maternal age, gestational week of inclusion in the study, obstetric features, maternal body mass index values, caffeine consumption, smoking status, maternal education status, placental localization and fetal gender.
Description
Inclusion Criteria:
- The study population included spontaneous, singleton pregnancies at first and second-trimester of their pregnancy
Exclusion Criteria:
- Multiple pregnancies, evidence of fetal or maternal infection, hypertensive disorders of gestation, gestational and pregestational diabetes mellitus, maternal drug use, evidence of fetal congenital abnormalities and amniotic fluid abnormalities were stated as the exclusion criteria for the study group.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Early perception group
The group with early perception of fetal movement (<25th percentile)
|
|
Average perception group
The group with average perception of fetal movement (>25th and <75th percentile)
|
|
Late perception group
The group which late perception of fetal movement (>75 percentile)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
placental settlement via ultrasound
Time Frame: 5 minutes
|
Relationship between placental location obtained via sonography and fetal movement perception
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
maternal body mass index measurement
Time Frame: 3 minutes
|
Relationship between Maternal Body Mass Index calculated by dividing body weight to height and fetal movement perception
|
3 minutes
|
|
maternal age
Time Frame: 1 minute
|
Relationship between Maternal age according to questionnaire and fetal movement perception
|
1 minute
|
|
parity
Time Frame: 1 minute
|
Relationship between Maternal parity according to questionnaire and fetal movement perception
|
1 minute
|
|
educational status
Time Frame: 1 minute
|
Relationship between maternal education status according to questionnaire and fetal movement perception
|
1 minute
|
|
smoking
Time Frame: 1 minute
|
Relationship between Maternal smoking according to questionnaire and fetal movement perception
|
1 minute
|
|
tea and coffee consumption
Time Frame: 1 minute
|
Relationship between maternal tea and coffee conception according to questionnaire and fetal movement perception
|
1 minute
|
|
fetal gender
Time Frame: 5 minutes
|
Relationship between fetal gender obtained via sonography and fetal movement perception
|
5 minutes
|
|
regular pregnancy follow ups
Time Frame: 1 minute
|
Relationship between regular pregnancy follow ups recorded on patient record system and fetal movement perception
|
1 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hatice Akkaya, M.D, Kayseri Education and Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (ACTUAL)
October 1, 2016
Study Completion (ACTUAL)
October 1, 2016
Study Registration Dates
First Submitted
November 26, 2016
First Submitted That Met QC Criteria
November 29, 2016
First Posted (ESTIMATE)
December 2, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
December 2, 2016
Last Update Submitted That Met QC Criteria
November 29, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- E52332816/53
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data belonging to participant will be available to any researcher or editorial review board if needed.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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