Fetal WeightNCT05478798
Comparison of Three Methods for Fetal Weight Estimation
An observational study of Fetal Weight and Obesity, Morbid, run by Western Galilee Hospital-Nahariya.
Trial summary
The aim of this study was to compare maternal, clinical and ultrasound estimations of fetal weight in women with severe (BMI>35) and morbid (BMI>40) obesity and to determine the effect of maternal body mass index (BMI) on these estimations. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Weight, Obesity, Morbid, Pregnancy Related
- What is being tested?
- ultrasonographic fetal weight estimation, clinical fetal weight estimation and maternal subjective fetal weight estimation
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 31 Dec 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: pregnant women in term singleton pregnancy
Who may be able to join
- Pregnant women ≥ 37 weeks
- BMI ≥ 35
- Singleton pregnancies
- Fetal weight estimate within two weeks from delivery
Who cannot join
- Primiparity
- Women who will give birth in a different hospital
- Multiple pregnancy
- Moderate to severe polyhydramnios
- Severe fetal malformations - such as hydrocephalus, hydrops fetalis
- Maternal age < 18 years
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Three Methods of Fetal Weight Estimation in Patients With Severe and Morbid Obesity
The aim of this study was to compare maternal, clinical and ultrasound estimations of fetal weight in women with severe (BMI>35) and morbid (BMI>40) obesity and to determine the effect of maternal body mass index (BMI) on these estimations.
Read the detailed description
Accuracy of fetal weight estimation is of key importance in antenatal care, as well as in the planning and management of labor and mode of delivery. In order to achieve more accurate prenatal fetal weight estimations and align these with a risk-optimizing mode of delivery, additional tools supporting the standard of use with ultrasound are needed.
The main ultrasonic methods used to calculate the weight of a fetus are based on measurement of fetal abdominal circumference (AC) and estimated fetal weight (EFW) using a formula first described by Hadlock, and the sufficient accuracy of this model has recently been proven.
Leopold's maneuvers have a long-standing tradition in obstetrics and midwifery. By placing both hands on the woman's abdomen the examiner can describe the position of the fetus as well as the level of the uterine fundus and thus detect a disproportion between fetus and the female pelvis. Experienced examiners are able to give a clinical estimation of fetal weight after performing Leopold's maneuvers including symphysis-fundal height and abdominal palpation. Maternal body mass index (BMI) has been shown to affect the accuracy of EFW. For example overweight (BMI>25) patients had found an absolute % error >10% in fetal weight estimation in 42.2% and 24.4% of cases, using Leopold's maneuvers and ultrasound, respectively. Maternal estimation of the fetus weight is as accurate as physicians; clinical estimations, and is advised as a complementary method of assessment. The aim of this study was to compare maternal, clinical and ultrasound estimations of fetal weight in women with severe (BMI>35) and morbid (BMI>40) obesity and to determine the effect of maternal body mass index (BMI) on these estimations.
Pregnant women ≥ 37 weeks and with BMI ≥ 35 with singleton who are admitted before delivery will be offered to participate in the study.
- A clinical weight estimate will be performed by a trained professional physician using Leopold's maneuvers.
- An ultrasonographic estimate will be performed in our ultrasound unit and a calculation by the ultrasound machine is based on Hadlock's formula [3] including measurement of biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC) and femur length (FL).
- For maternal estimate, patients will be asked to give a fetal weight estimation.
- Conditions
- Fetal Weight, Obesity, Morbid, Pregnancy Related
- Being tested
- ultrasonographic fetal weight estimation, clinical fetal weight estimation, maternal subjective fetal weight estimation
- Keywords
- fetal weight estimation, ultrasound, maternal subjective estimation, term pregnancy, clinical estimation
- Medical subject headings
- Fetal Weight, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographic fetal weight estimationOther
An ultrasonographic estimate will be performed in our ultrasound unit and a calculation by the ultrasound machine is based on Hadlock's formula including measurement of biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC) and femur length (FL).
clinical fetal weight estimationOther
A clinical weight estimate will be performed by using Leopold's maneuvers
maternal subjective fetal weight estimationOther
the pregnant woman will tell her subjective estimation of fetal weight estimation
What is being measured
The primary outcome is the main question the study is designed to answer.
fetal actual birth weight
fetal actual birth in grams
Measured: immediately after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (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 Fetal WeightStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Inshirah Sgayer, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478798
- Sponsor's protocol ID
- NHR
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sgayer I, Francis YN, Ashkar-Majadla N, Tuma R, Lowenstein L, Frank Wolf M, Odeh M. Three Methods of Fetal Weight Estimation Compared in Women With BMI >/= 35 kg/m2 at Term-A Prospective Observational Study. Birth. 2026 Sep;53(3):491-496. doi: 10.1111/birt.70041. Epub 2025 Nov 25.
PubMed 41287954
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Methods of Fetal Weight Estimation in Patients With Severe and Morbid Obesity
- ClinicalTrials.gov ID
- NCT05478798
- Acronym / sponsor ID
- NHR
- Conditions
- Fetal Weight, Obesity, Morbid, Pregnancy Related
- Keywords
- fetal weight estimation, ultrasound, maternal subjective estimation, term pregnancy, clinical estimation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Jul 2022 (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.
The aim of this study was to compare maternal, clinical and ultrasound estimations of fetal weight in women with severe (BMI>35) and morbid (BMI>40) obesity and to determine the effect of maternal body mass index (BMI) on these estimations.
Detailed description
Accuracy of fetal weight estimation is of key importance in antenatal care, as well as in the planning and management of labor and mode of delivery. In order to achieve more accurate prenatal fetal weight estimations and align these with a risk-optimizing mode of delivery, additional tools supporting the standard of use with ultrasound are needed.
The main ultrasonic methods used to calculate the weight of a fetus are based on measurement of fetal abdominal circumference (AC) and estimated fetal weight (EFW) using a formula first described by Hadlock, and the sufficient accuracy of this model has recently been proven.
Leopold's maneuvers have a long-standing tradition in obstetrics and midwifery. By placing both hands on the woman's abdomen the examiner can describe the position of the fetus as well as the level of the uterine fundus and thus detect a disproportion between fetus and the female pelvis. Experienced examiners are able to give a clinical estimation of fetal weight after performing Leopold's maneuvers including symphysis-fundal height and abdominal palpation. Maternal body mass index (BMI) has been shown to affect the accuracy of EFW. For example overweight (BMI>25) patients had found an absolute % error >10% in fetal weight estimation in 42.2% and 24.4% of cases, using Leopold's maneuvers and ultrasound, respectively. Maternal estimation of the fetus weight is as accurate as physicians; clinical estimations, and is advised as a complementary method of assessment. The aim of this study was to compare maternal, clinical and ultrasound estimations of fetal weight in women with severe (BMI>35) and morbid (BMI>40) obesity and to determine the effect of maternal body mass index (BMI) on these estimations.
Pregnant women ≥ 37 weeks and with BMI ≥ 35 with singleton who are admitted before delivery will be offered to participate in the study.
- A clinical weight estimate will be performed by a trained professional physician using Leopold's maneuvers.
- An ultrasonographic estimate will be performed in our ultrasound unit and a calculation by the ultrasound machine is based on Hadlock's formula [3] including measurement of biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC) and femur length (FL).
- For maternal estimate, patients will be asked to give a fetal weight estimation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women in term singleton pregnancy
Key inclusion criteria (4 listed)
- Pregnant women ≥ 37 weeks
- BMI ≥ 35
- Singleton pregnancies
- Fetal weight estimate within two weeks from delivery
Key exclusion criteria (6 listed)
- Primiparity
- Women who will give birth in a different hospital
- Multiple pregnancy
- Moderate to severe polyhydramnios
- Severe fetal malformations - such as hydrocephalus, hydrops fetalis
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 |
|---|---|---|
| ultrasonographic fetal weight estimationAn ultrasonographic estimate will be performed in our ultrasound unit and a calculation by the ultrasound machine is based on Hadlock's formula including measurement of biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC) and femur length (FL). | Other | – |
| clinical fetal weight estimationA clinical weight estimate will be performed by using Leopold's maneuvers | Other | – |
| maternal subjective fetal weight estimationthe pregnant woman will tell her subjective estimation of fetal weight estimation | Other | – |
Primary outcome
fetal actual birth weight
Time frame: immediately after delivery
fetal actual birth in grams
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Derived from this study: PubMed 41287954Sgayer I, Francis YN, Ashkar-Majadla N, Tuma R, Lowenstein L, Frank Wolf M, Odeh M. Three Methods of Fetal Weight Estimation Compared in Women With BMI >/= 35 kg/m2 at Term-A Prospective Observational Study. Birth. 2026 Sep;53(3):491-496. doi: 10.1111/birt.70041. Epub 2025 Nov 25.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Weight and Obesity, Morbid, run by Western Galilee Hospital-Nahariya.
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 4 inclusion and 6 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 28 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact inshirah sgayer (+972-0508890662, inshirah.sg.sh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fetal actual birth weight (time frame: immediately after delivery). 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 NCT05478798, 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 28 Jul 2022.