Early PregnancyFFMNCT02979834
When Will I Feel The First Movements of My Baby?
An observational study of Early Pregnancy, run by Kayseri Education and Research Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early Pregnancy
- How many people
- 423 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Oct 2016
- Phase
- Observational
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- The study population included spontaneous, singleton pregnancies at first and second-trimester of their pregnancy
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Early Pregnancy
- Keywords
- fetal movement, placenta site, body mass index, maternal education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
placental settlement via ultrasound
Relationship between placental location obtained via sonography and fetal movement perception
Measured: 5 minutes
Secondary outcomes (8)
maternal body mass index measurement
Relationship between Maternal Body Mass Index calculated by dividing body weight to height and fetal movement perception
Measured: 3 minutes
maternal age
Relationship between Maternal age according to questionnaire and fetal movement perception
Measured: 1 minute
parity
Relationship between Maternal parity according to questionnaire and fetal movement perception
Measured: 1 minute
educational status
Relationship between maternal education status according to questionnaire and fetal movement perception
Measured: 1 minute
smoking
Relationship between Maternal smoking according to questionnaire and fetal movement perception
Measured: 1 minute
tea and coffee consumption
Relationship between maternal tea and coffee conception according to questionnaire and fetal movement perception
Measured: 1 minute
fetal gender
Relationship between fetal gender obtained via sonography and fetal movement perception
Measured: 5 minutes
regular pregnancy follow ups
Relationship between regular pregnancy follow ups recorded on patient record system and fetal movement perception
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early PregnancyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hatice Akkaya, Kayseri Education and Research Hospital
- Investigators
- Hatice Akkaya, M.D, Principal investigator, Kayseri Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979834
- Sponsor's protocol ID
- E52332816/53
- Acronym
- FFM
- Status last verified
- Nov 2016
- First submitted
- 26 Nov 2016
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data belonging to participant will be available to any researcher or editorial review board if needed.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Frequently Asked Question: When Will I Feel The First Movements of My Baby?
- ClinicalTrials.gov ID
- NCT02979834
- Acronym / sponsor ID
- FFM / E52332816/53
- Conditions
- Early Pregnancy
- Keywords
- fetal movement, placenta site, body mass index, maternal education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- Jun 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 2 Dec 2016 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- The study population included spontaneous, singleton pregnancies at first and second-trimester of their pregnancy
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
placental settlement via ultrasound
Time frame: 5 minutes
Relationship between placental location obtained via sonography and fetal movement perception
8 secondary outcomes
maternal body mass index measurement
Time frame: 3 minutes
maternal age
Time frame: 1 minute
parity
Time frame: 1 minute
educational status
Time frame: 1 minute
smoking
Time frame: 1 minute
tea and coffee consumption
Time frame: 1 minute
fetal gender
Time frame: 5 minutes
regular pregnancy follow ups
Time frame: 1 minute
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 2 Dec 2016.
- Individual participant dataSharing planned: Yes. The data belonging to participant will be available to any researcher or editorial review board if needed.
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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.
Hatice Akkaya, M.D principal investigator
Kayseri Education and Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Early Pregnancy, run by Kayseri Education and Research Hospital.
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 1 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 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
placental settlement via ultrasound (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2016.