MacrosomiaECHO-MACRONCT07433751
Ultrasound Estimation of Fetal Macrosomia at Term: Diagnostic Accuracy Within 24 Hours of Delivery
A study testing Ultrasound estimation of fetal macrosomia at 12 weeks of amenorrhea, Ultrasound estimation of fetal macrosomia at 22 weeks of amenorrhea and Ultrasound estimation of fetal macrosomia at 32 weeks of amenorrhea in people with Macrosomia and Fetal Weight, run by Centre Hospitalier Henri Duffaut - Avignon at 1 site in France.
Trial summary
Obstetric ultrasonography is now an essential tool for monitoring pregnancy. In France, three ultrasounds are recommended during a singleton pregnancy (at 12, 22, and 32 weeks of amenorrhea) to improve maternal and neonatal care. 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
- Macrosomia, Fetal Weight
- What is being tested?
- Ultrasound estimation of fetal macrosomia at 12 weeks of amenorrhea, Ultrasound estimation of fetal macrosomia at 22 weeks of amenorrhea and Ultrasound estimation of fetal macrosomia at 32 weeks of amenorrhea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥ 18 years old.
- Patient with suspected fetal macrosomia above the 95th percentile, or above the 90th percentile in the case of maternal diabetes, according to Hadlock's formula and WHO charts, during the third-trimester ultrasound (between 32 and 34 weeks of amenorrhea).
- Female patient presenting for a follow-up ultrasound at 36 ± 1 weeks of amenorrhea due to suspected macrosomia.
- Singleton pregnancy.
Who cannot join
- Fetal weight estimation at 36 ± 1 weeks of amenorrhea and macrosomia assessment performed outside of the hospital.
- Patient with uncertain gestational age.
- Patient with a multiple pregnancy
- Presence of detectable morphological or chromosomal abnormalities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier d'Avignon, Hôpital Henri Duffaut
Avignon, 84000
Marilyne Grinand, PhD, (+33)0432759392, grinand.marilyne@ch-avignon.fr
Jean-Yves Col, MD
About this study
Official title: ECHO-MACRO : Ultrasound Estimation of Fetal Macrosomia at Term: Diagnostic Accuracy Within 24 Hours of Delivery
Obstetric ultrasonography is now an essential tool for monitoring pregnancy. In France, three ultrasounds are recommended during a singleton pregnancy (at 12, 22, and 32 weeks of amenorrhea) to improve maternal and neonatal care. Among the parameters studied, fetal weight estimation allows for the assessment of fetal growth and the detection of certain conditions such as intrauterine growth restriction or macrosomia.
Fetal weight estimation is based primarily on the Hadlock formula, which combines several biometric measurements (head circumference, abdominal circumference, and femur length). This estimate has a margin of error of 6 to 10% compared to birth weight, which is still accurate enough to guide important medical decisions, such as inducing labor or performing a cesarean section. However, an estimation error can have negative consequences for both mother and child.
Read more
Fetal macrosomia is defined as a birth weight greater than or equal to 4000 g. It affects approximately 5 to 10% of pregnancies. Screening is mainly based on ultrasound, particularly in the second and third trimesters.
Macrosomia is associated with an increased risk of complications for the mother (cesarean section, postpartum hemorrhage, or deep vein thrombosis) and the child (shoulder dystocia, fractures, brachial plexus palsy, or neonatal asphyxia). These risks are increased in cases of macrosomia in the context of maternal diabetes.
Within the gynecology-obstetrics department, physicians use the protocole of macrosomia screening described in the DAME trial. If macrosomia is suspected an additional ultrasound is performed at around 36 weeks of amenorrhea. The Hadlock formula is used to estimate fetal weight. The ultrasound criteria for suspecting macrosomia are an estimated fetal weight above the 95th percentile (90th percentile in cases of maternal diabetes) according to WHO curves. In these cases, induction is offered between 38 and 39 weeks of amenorrhea, if the cervix is favorable. A cesarean section is offered to the patient if the estimated fetal weight is greater than 5000 g in the absence of diabetes and greater than 4500 g in cases of associated diabetes.
Nevertheless, the probability of a child being born macrosomic after ultrasound suspicion is between 17% and 80% on average, and 53% in our center. Although beneficial in the context of macrosomia, the effects of induced labor or cesarean delivery are not insignificant for the mother and her baby. In this context, the value of this study is to demonstrate that performing an ultrasound as close to the birth as possible could allow for a more reliable estimation of fetal weight and better detection of macrosomia in order to avoid unnecessary procedures.
The investigators hypothesize that fetal weight estimation is more accurate when performed within 24 hours prior to delivery. When the assessment is conducted earlier, it inherently assumes a constant fetal growth rate until birth, which may not reflect actual growth patterns. A more precise estimation of birth weight could improve clinical decision-making and optimize maternal and neonatal care, potentially reducing unnecessary interventions such as labor induction or cesarean delivery.
- Conditions
- Macrosomia, Fetal Weight
- Being tested
- Ultrasound estimation of fetal macrosomia at 12 weeks of amenorrhea, Ultrasound estimation of fetal macrosomia at 22 weeks of amenorrhea, Ultrasound estimation of fetal macrosomia at 32 weeks of amenorrhea, Ultrasound estimation of fetal macrosomia before birth
- Keywords
- Macrosomia, Fetal weight, Ultrasound
- Medical subject headings
- Fetal Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound estimation of fetal macrosomia at 12 weeks of amenorrheaDiagnostic test
Ultrasound estimation of fetal macrosomia at 12 weeks of amenorrhea (estimated weight according to the Hadlock formula and WHO growth charts)
Ultrasound estimation of fetal macrosomia at 22 weeks of amenorrheaDiagnostic test
Ultrasound estimation of fetal macrosomia at 22 weeks of amenorrhea (estimated weight according to the Hadlock formula and WHO growth charts)
Ultrasound estimation of fetal macrosomia at 32 weeks of amenorrheaDiagnostic test
Ultrasound estimation of fetal macrosomia at 32 weeks of amenorrhea (estimated weight according to the Hadlock formula and WHO growth charts)
Ultrasound estimation of fetal macrosomia before birthDiagnostic test
Ultrasound estimation of fetal macrosomia within 24 hours ± 6 hours, prior to birth (estimated weight according to the Hadlock formula and WHO growth charts)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Macrosomia confirmed by ultrasound at 36 weeks Receives: Diagnostic Test: Ultrasound estimation of fetal macrosomia at 12 weeks of amenorrhea; Diagnostic Test: Ultrasound estimation of fetal macrosomia at 22 weeks of amenorrhea; Diagnostic Test: Ultrasound estimation of fetal macrosomia at 32 weeks of amenorrhea; Diagnostic Test: Ultrasound estimation of fetal macrosomia before birth |
| Group 2 | Other | Macrosomia not confirmed by ultrasound Receives: Diagnostic Test: Ultrasound estimation of fetal macrosomia at 12 weeks of amenorrhea; Diagnostic Test: Ultrasound estimation of fetal macrosomia at 22 weeks of amenorrhea; Diagnostic Test: Ultrasound estimation of fetal macrosomia at 32 weeks of amenorrhea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of fetal macrosomia
Frequency will be expressed as numbers and percentages
Measured: 24 hours before birth
Secondary outcomes (1)
Assess the diagnostic performance of the different ultrasound examinations for the detection of fetal macrosomia at birth.
By analyzing true-positive, false-positive, true-negative, and false-negative rates in a 2x2 contigency table
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start8 Apr 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MacrosomiaStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Duffaut - Avignon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433751
- Sponsor's protocol ID
- ECHO-MACRO
- Acronym
- ECHO-MACRO
- Status last verified
- Jun 2026
- First submitted
- 19 Feb 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECHO-MACRO : Ultrasound Estimation of Fetal Macrosomia at Term: Diagnostic Accuracy Within 24 Hours of Delivery
- ClinicalTrials.gov ID
- NCT07433751
- Acronym / sponsor ID
- ECHO-MACRO / ECHO-MACRO
- Conditions
- Macrosomia, Fetal Weight
- Keywords
- Macrosomia, Fetal weight, Ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Centre Hospitalier Henri Duffaut - AvignonUniversity, hospital or other
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 25 Feb 2026 (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.
Obstetric ultrasonography is now an essential tool for monitoring pregnancy. In France, three ultrasounds are recommended during a singleton pregnancy (at 12, 22, and 32 weeks of amenorrhea) to improve maternal and neonatal care. Among the parameters studied, fetal weight estimation allows for the assessment of fetal growth and the detection of certain conditions such as intrauterine growth restriction or macrosomia.
Fetal weight estimation is based primarily on the Hadlock formula, which combines several biometric measurements (head circumference, abdominal circumference, and femur length). This estimate has a margin of error of 6 to 10% compared to birth weight, which is still accurate enough to guide important medical decisions, such as inducing labor or performing a cesarean section. However, an estimation error can have negative consequences for both mother and child.
Fetal macrosomia is defined as a birth weight greater than or equal to 4000 g. It affects approximately 5 to 10% of pregnancies. Screening is mainly based on ultrasound, particularly in the second and third trimesters.
Macrosomia is associated with an increased risk of complications for the mother (cesarean section, postpartum hemorrhage, or deep vein thrombosis) and the child (shoulder dystocia, fractures, brachial plexus palsy, or neonatal asphyxia). These risks are increased in cases of macrosomia in the context of maternal diabetes.
Within the gynecology-obstetrics department, physicians use the protocole of macrosomia screening described in the DAME trial. If macrosomia is suspected an additional ultrasound is performed at around 36 weeks of amenorrhea. The Hadlock formula is used to estimate fetal weight. The ultrasound criteria for suspecting macrosomia are an estimated fetal weight above the 95th percentile (90th percentile in cases of maternal diabetes) according to WHO curves. In these cases, induction is offered between 38 and 39 weeks of amenorrhea, if the cervix is favorable. A cesarean section is offered to the patient if the estimated fetal weight is greater than 5000 g in the absence of diabetes and greater than 4500 g in cases of associated diabetes.
Nevertheless, the probability of a child being born macrosomic after ultrasound suspicion is between 17% and 80% on average, and 53% in our center. Although beneficial in the context of macrosomia, the effects of induced labor or cesarean delivery are not insignificant for the mother and her baby. In this context, the value of this study is to demonstrate that performing an ultrasound as close to the birth as possible could allow for a more reliable estimation of fetal weight and better detection of macrosomia in order to avoid unnecessary procedures.
The investigators hypothesize that fetal weight estimation is more accurate when performed within 24 hours prior to delivery. When the assessment is conducted earlier, it inherently assumes a constant fetal growth rate until birth, which may not reflect actual growth patterns. A more precise estimation of birth weight could improve clinical decision-making and optimize maternal and neonatal care, potentially reducing unnecessary interventions such as labor induction or cesarean delivery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Diagnostic Test: Ultrasound estimation of fetal macrosomia at 12 weeks of amenorrhea, Diagnostic Test: Ultrasound estimation of fetal macrosomia at 22 weeks of amenorrhea, Diagnostic Test: Ultrasound estimation of fetal macrosomia at 32 weeks of amenorrhea, Diagnostic Test: Ultrasound estimation of fetal macrosomia before birthMacrosomia confirmed by ultrasound at 36 weeks |
| Group 2 | Other | Diagnostic Test: Ultrasound estimation of fetal macrosomia at 12 weeks of amenorrhea, Diagnostic Test: Ultrasound estimation of fetal macrosomia at 22 weeks of amenorrhea, Diagnostic Test: Ultrasound estimation of fetal macrosomia at 32 weeks of amenorrheaMacrosomia not confirmed by ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old.
- Patient with suspected fetal macrosomia above the 95th percentile, or above the 90th percentile in the case of maternal diabetes, according to Hadlock's formula and WHO charts, during the third-trimester ultrasound (between 32 and 34 weeks of amenorrhea).
- Female patient presenting for a follow-up ultrasound at 36 ± 1 weeks of amenorrhea due to suspected macrosomia.
- Singleton pregnancy.
Key exclusion criteria (4 listed)
- Fetal weight estimation at 36 ± 1 weeks of amenorrhea and macrosomia assessment performed outside of the hospital.
- Patient with uncertain gestational age.
- Patient with a multiple pregnancy
- Presence of detectable morphological or chromosomal abnormalities.
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 |
|---|---|---|
| Ultrasound estimation of fetal macrosomia at 12 weeks of amenorrheaUltrasound estimation of fetal macrosomia at 12 weeks of amenorrhea (estimated weight according to the Hadlock formula and WHO growth charts) | Diagnostic test | Group 1, Group 2 |
| Ultrasound estimation of fetal macrosomia at 22 weeks of amenorrheaUltrasound estimation of fetal macrosomia at 22 weeks of amenorrhea (estimated weight according to the Hadlock formula and WHO growth charts) | Diagnostic test | Group 1, Group 2 |
| Ultrasound estimation of fetal macrosomia at 32 weeks of amenorrheaUltrasound estimation of fetal macrosomia at 32 weeks of amenorrhea (estimated weight according to the Hadlock formula and WHO growth charts) | Diagnostic test | Group 1, Group 2 |
| Ultrasound estimation of fetal macrosomia before birthUltrasound estimation of fetal macrosomia within 24 hours ± 6 hours, prior to birth (estimated weight according to the Hadlock formula and WHO growth charts) | Diagnostic test | Group 1 |
Primary outcome
Frequency of fetal macrosomia
Time frame: 24 hours before birth
Frequency will be expressed as numbers and percentages
1 secondary outcome
Assess the diagnostic performance of the different ultrasound examinations for the detection of fetal macrosomia at birth.
Time frame: At birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound estimation of fetal macrosomia at 12 weeks of amenorrhea, Ultrasound estimation of fetal macrosomia at 22 weeks of amenorrhea and Ultrasound estimation of fetal macrosomia at 32 weeks of amenorrhea in people with Macrosomia and Fetal Weight, run by Centre Hospitalier Henri Duffaut - Avignon at 1 site in France.
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 4 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marilyne Grinand, PhD ((+33)432759392, grinand.marilyne@ch-avignon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of fetal macrosomia (time frame: 24 hours before birth). 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 16 Jun 2026.