Ultrasonography, PrenatalTSFWNCT03206281
Tall Stature Women Fetal Weight Estimation
An observational study of Ultrasonography, Prenatal, run by Meir Medical Center at 1 site in Israel.
Trial summary
To investigate the difference of clinical VS sonographic fetal weight estimation of tall women stature (above 10t percentile) Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ultrasonography, Prenatal
- What is being tested?
- Fetal wight estimation
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Jul 2017to 29 Sep 2018
- How long will I take part?
- 1 Year
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women
Who may be able to join
- Pregnant women above 172 cm height
- above 39 weeks of gestation
Who cannot join
- contraindication for vaginal delivery
- Intrauterus growth restriction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tall Stature Women Fetal Weight Estimation,Clinical Versus Sonographic Estimation
To investigate the difference of clinical VS sonographic fetal weight estimation of tall women stature (above 10t percentile)
Read the detailed description
Women undergoing delivery after week 39 will be estimated of their fetal wight with clinical estimation and then sonographic estimation.
each women will be case control 1:1 for the actual fetal weight of the delivery.
the fetal weight will be blinded for each estimation.
Primary outcome is the actual fetal weight Secondary outcomes will be mode of delivery, fetal complication as APGAR score and fetal hypoxia and maternal complication as perineal laceration
- Conditions
- Ultrasonography, Prenatal
- Being tested
- Fetal wight estimation
- Keywords
- clinical weight estimation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal wight estimationDiagnostic test
We will estimate the fetal weight by sonographic and clinical estimation
| Study group | Role | What they receive |
|---|---|---|
| Clinical fetal weight estimation | The fetal weight estimation will be taken by professional obstetrician durin her 39 week Receives: Diagnostic Test: Fetal wight estimation | |
| Sonographic fetal weight estimation | The fetal weight estimation will be taken by professional Sonographic obstetrician durin her 39 week Receives: Diagnostic Test: Fetal wight estimation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of fetal weight estimation
Comparing the sonographic and clinical fetal weight estimation to the actual fetal weight
Measured: 2 weeks
Secondary outcomes (1)
Mode of delivery and fetal complication
Vaginal Versus cesarian section delivery
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start5 Jul 2017 (estimated)
- Primary completion29 Aug 2018 (estimated)
- Study completion29 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ultrasonography, PrenatalStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yair Daykan, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206281
- Sponsor's protocol ID
- MMC-0016-17
- Acronym
- TSFW
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: within 6m of finishing the study
Publications
Daykan Y, Shavit M, Yagur Y, Schreiber H, Weitzner O, Schonman R, Biron-Shental T, Markovitch O. Fetal weight estimation in tall women: is ultrasound more accurate than clinical assessment? A prospective trial. Arch Gynecol Obstet. 2022 Mar;305(3):567-572. doi: 10.1007/s00404-021-06177-6. Epub 2021 Aug 11.
PubMed 34382135
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tall Stature Women Fetal Weight Estimation,Clinical Versus Sonographic Estimation
- ClinicalTrials.gov ID
- NCT03206281
- Acronym / sponsor ID
- TSFW / MMC-0016-17
- Conditions
- Ultrasonography, Prenatal
- Keywords
- clinical weight estimation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 5 Jul 2017 (estimated)
- Primary completion
- 29 Aug 2018 (estimated)
- Study completion
- 29 Sep 2018 (estimated)
- First posted
- 2 Jul 2017 (actual)
- 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.
To investigate the difference of clinical VS sonographic fetal weight estimation of tall women stature (above 10t percentile)
Detailed description
Women undergoing delivery after week 39 will be estimated of their fetal wight with clinical estimation and then sonographic estimation.
each women will be case control 1:1 for the actual fetal weight of the delivery.
the fetal weight will be blinded for each estimation.
Primary outcome is the actual fetal weight Secondary outcomes will be mode of delivery, fetal complication as APGAR score and fetal hypoxia and maternal complication as perineal laceration
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical fetal weight estimation | – | Diagnostic Test: Fetal wight estimationThe fetal weight estimation will be taken by professional obstetrician durin her 39 week |
| Sonographic fetal weight estimation | – | Diagnostic Test: Fetal wight estimationThe fetal weight estimation will be taken by professional Sonographic obstetrician durin her 39 week |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women
Key inclusion criteria (2 listed)
- Pregnant women above 172 cm height
- above 39 weeks of gestation
Key exclusion criteria (2 listed)
- contraindication for vaginal delivery
- Intrauterus growth restriction
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 wight estimationWe will estimate the fetal weight by sonographic and clinical estimation | Diagnostic test | Clinical fetal weight estimation, Sonographic fetal weight estimation |
Primary outcome
The accuracy of fetal weight estimation
Time frame: 2 weeks
Comparing the sonographic and clinical fetal weight estimation to the actual fetal weight
1 secondary outcome
Mode of delivery and fetal complication
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Derived from this study: PubMed 34382135Daykan Y, Shavit M, Yagur Y, Schreiber H, Weitzner O, Schonman R, Biron-Shental T, Markovitch O. Fetal weight estimation in tall women: is ultrasound more accurate than clinical assessment? A prospective trial. Arch Gynecol Obstet. 2022 Mar;305(3):567-572. doi: 10.1007/s00404-021-06177-6. Epub 2021 Aug 11.
- Individual participant dataSharing planned: Yes. within 6m of finishing the study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasonography, Prenatal, run by Meir Medical Center at 1 site in Israel.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Jul 2017. 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 Israel. 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?
Results are not available in the source record.
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?
The accuracy of fetal weight estimation (time frame: 2 weeks). 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 NCT03206281, which also lists 1 linked publication.
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 Jul 2017.