Fetal MacrosomiaNCT02713568
Estimation of Fetal Weight by MR Imaging to PREdict Neonatal MACROsomia (PREMACRO Study)
A study testing Ultrasound examination and Magnetic resonance examination in people with Fetal Macrosomia, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
Macrosomia and growth restriction are important causes of perinatal morbidity, at or near to term. However, clear identification of 'at risk' foetuses is difficult and clinical estimates of fetal weight are poor. 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 Macrosomia
- What is being tested?
- Ultrasound examination and Magnetic resonance examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,413 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Mar 2016to 10 Mar 2020
- Phase
- Interventional
- 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
Who may be able to join
- Subjects is ≥ 18 years of age and able to provide a written informed consent.
- Subject is a pregnant woman carrying a live singleton fetus at the 36+0-36+6 weeks scan, with no major abnormalities appearing during prenatal imaging with no major abnormalities appearing during prenatal imaging potentially affecting the correct use of the Hadlock formula for US-EFW. Conditions such as congenital diaphragmatic hernia with decreased abdominal circumference could be underestimated by the Hadlock USEFW. Another example is a massive sacro-coccygial teratomas.
- Subject is planning a delivery at our maternity at the University Hospital Brugmann, in Brussels, Belgium.
- Subject is known not to have any contra-indication to undergo an MR imaging examination.
Who cannot join
- Subject is known to have a contra-indication to undergo an MR imaging examination such as: Carrying a pacemaker or a metallic cardiac valve, having metallic material inside the head, having metallic fragments inside the eye following an accident, having any type of implant including ear implant, having a hip prosthesis
- Subject presenting with painful regular uterine contractions or history of ruptured membranes.
- Subjects who are unconscious, severely ill, mentally handicapped or under the age of 18 years.
- If birth occurs before MR and US evaluation.
- If patients delivers outside our local maternity unit.
- If the neonate's weigh is not measured within 6 hours after birth for any reason, including the need for emergency care immediately after delivery
Trial locations and contacts
1 site in 1 country.
About this study
Macrosomia and growth restriction are important causes of perinatal morbidity, at or near to term. However, clear identification of 'at risk' foetuses is difficult and clinical estimates of fetal weight are poor. Historically, ultrasound has been used as a second line in such cases but the accuracy of this imaging modality in the mid- to late third trimester is also limited.
Estimated fetal weight (EFW) is an important part of the clinical assessment and is used to guide obstetric interventions, when a fetus is small or large for dates. It frequently is the single most important component guiding interventions, such as induction of labour or Caesarean section.
Read more
Due to the imprecision of ultrasound-derived EFW, particularly in cases of suspected macrosomia in the 3rd trimester, the investigators believe that these estimates should not be used to make important obstetric decisions regarding mode and timing of delivery and that a more accurate method of assessment could produce better outcomes by restricting interventions to those foetuses at greatest risk. Some publications have already demonstrated that magnetic resonance (MR) imaging derived-EFW close to delivery, is more accurate than ultrasound
The goal of the present study is thus to compare the performance of magentic resonance imaging derived-EFW, versus ultrasound derived-EFW at 36 weeks of gestation, regarding the prediction of neonatal macrosomia.
Read the detailed description
Macrosomia and growth restriction are important causes of perinatal morbidity, at or near to term. However, clear identification of 'at risk' foetuses is difficult and clinical estimates of fetal weight are poor. Historically, ultrasound has been used as a second line in such cases but the accuracy of this imaging modality in the mid- to late third trimester is also limited.
Estimated fetal weight (EFW) is an important part of the clinical assessment and is used to guide obstetric interventions, when a fetus is small or large for dates. When a diagnosis of intra-uterine growth restriction (IUGR) is made, the decision-making process is complex, particularly at very early gestations and involves multiple different factors, including maternal status, cardiotocography, liquor volume and dopplers. However, a large body of research is now available to assist with the management of both early and late-onset intrauterine growth restriction (IUGR) but there is a paucity of evidence to guide clinical practice, once macrosomia has been diagnosed, therefore the EFW is frequently the single most important component guiding interventions, such as induction of labour or Caesarean section.
Fetal macrosomia is associated with a higher incidence of perinatal morbidity, including shoulder dystocia and brachial plexus injury in the fetus and anal sphincter tears, uterine atony and haemorrhage in the mother. A recent multicentre randomised controlled trial appears to confirm the advantages of a policy of induction of labour for suspected macrosomia, demonstrating a clear reduction in the rates of shoulder dystocia and composite perinatal morbidity. However, some earlier but lower quality, observational studies have questioned the benefit of EFW made by ultrasonography in the last trimester, for suspected macrosomia, demonstrating that this practice can increase the risk of caesarean and instrumental delivery, without reducing perinatal morbidity.
Despite this conflicting data and a lack of evidence to support routine third trimester ultrasound, the absence of specific guidance, coupled with concerns regarding perinatal outcomes,mean that obstetricians will increasingly request an ultrasound at around 34-36 weeks gestation to identify foetuses above the 90th or below the 10th centiles. This practice will inevitably lead to increased and potentially harmful interventions based on relatively inaccurate data.
Due to the imprecision of ultrasound-derived EFW, particularly in cases of suspected macrosomia in the 3rd trimester, the investigators believe that these estimates should not be used to make important obstetric decisions regarding mode and timing of delivery and that a more accurate method of assessment could produce better outcomes by restricting interventions to those foetuses at greatest risk. Some publications have already demonstrated that magnetic resonance (MR) imaging derived-EFW close to delivery, is more accurate than ultrasound, with a mean percentage error superior to that of ultrasound and a recent meta-analyses has confirmed this promising accuracy.
The goal of the present study is thus to compare the performance of magentic resonance imaging derived-EFW, versus ultrasound derived-EFW at 36 weeks of gestation, regarding the prediction of neonatal macrosomia.
- Conditions
- Fetal Macrosomia
- Being tested
- Ultrasound examination, Magnetic resonance examination
- Keywords
- Macrosomia, Magnetic Resonance- Estimated Fetal Weight, Ultrasound-Estimated Fetal Weight, Large-for-date fetus
- Medical subject headings
- Fetal Macrosomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examinationOther
Prenatal Ultrasound examinations will be carried out using transabdominal sonography only by experienced consultants in MFM. Ultrasound-Estimated Fetal Weight will be obtained between 36.0-36.6 weeks of gestation, according to Hadlock et al.
Operators performing the Ultrasound-Estimated Fetal Weight will be blinded to the results of Magnetic Resonance-Estimated Fetal Weight. The participants, general practitioners, obstetricians and midwifes of the patients will be aware of the results of Ultrasound-Estimated Fetal Weight which will be used for clinical management.
For the primary outcome measure, macrosomia during Ultrasound-Estimated Fetal Weight will be defined as ≥ P95 based on Yudkin et al. For secondary outcome measures, it will be redefined as ≥ P90 or ≥ P99 based on Yudkin.
Magnetic resonance examinationOther
MRI will be performed the same day as the Ultrasound examination, using a clinical 1.5T whole-body unit.
Operators performing Fetal Body Volume measurements will be blinded from Ultrasound-Estimated Fetal Weight results. Magnetic Resonance-Estimated Fetal Weight will be calculated using the equation 0,12+1,031*Fetal Body Volume = MR imaging weight (g) developed by Baker.
General practitioners, obstetricians and midwifes of the patients will be blinded to the results of the Magnetic Resonance-Estimated Fetal Weight.
For the primary outcome measure, macrosomia will be defined as ≥ P95 based on Yudkin et al. For secondary outcome measures, it will be defined as ≥ P90 or ≥ P99.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Active comparator | During routine third trimester ultrasound scan between 30 weeks and 35 weeks +6 days of gestational age, all women with an apparently normal, live singleton pregnancy, planning to deliver at the investigator's hospital maternity, will be invited to participate in the study.
An Ultrasound scan to estimate the fetal weigth will be carried out during the 36th week of gestation. Receives: Other: Ultrasound examination |
| Magnetic Resonance | Experimental | During routine third trimester ultrasound scan between 30 weeks and 35 weeks +6 days of gestational age, all women with an apparently normal, live singleton pregnancy, planning to deliver at the investigator's hospital maternity, will be invited to participate in the study.
A Magnetic Resonance examination to estimate the fetal weigth will be carried out during the 36th week of gestation. Receives: Other: Magnetic resonance examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (≥ P95)
AUROC for prediction of macrosomia (≥ P95 for gestational age; normal ranges of Yudkin et al.) with MR (4 mm ST (slice thickness)/ 20 mm gap) versus US using the Hadlock equation.
Measured: Between 36 weeks and 36 weeks + 6 days of gestation
Secondary outcomes (9)
Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (≥ P90)
AUROC for prediction of macrosomia (≥ P90 for gestational age) with magnetic resonnance (4 mm slice thickness/20 mm gap) versus ultrasound.
Measured: Between 36 weeks and 36 weeks + 6 days of gestation
Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (≥ P99)
AUROC for prediction of macrosomia (≥ P99 for gestational age) with Magnetic Resonance (4 mm slice thickness/ 20 mm gap) versus Ultrasound.
Measured: Between 36 weeks and 36 weeks + 6 days of gestation
Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (≥ P97)
AUROC for prediction of macrosomia (≥ P97 for gestational age) with Magnetic Resonance (4 mm slice thickness/ 20 mm gap) versus Ultrasound.
Measured: Between 36 weeks and 36 weeks + 6 days of gestation
Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (Abdominal Circumference)
AUROC for prediction of macrosomia with Abdominal Circumference ≥ P90 for gestational age. Measured in cm with Ultrasound
Measured: Between 36 weeks and 36 weeks + 6 days of gestation
Area Under the Receiver Operating Curve (AUROC) for prediction of 'Small for gestational age' (SGA)
Measured with Magnetic Resonnace (4 mm slice thickness)/ 20 mm gap) versus ultrasound.
Measured: Between 36 weeks and 36 weeks + 6 days of gestation
Comparative prediction rate for significant shoulder dystocia
Ability of Magnetic Resonnace-Estimated Fetal Weight (+/- pelvimetric measurements) vs. Ultrasound-Estimated Fetal Weigth in predicting significant shoulder dystocia. Significant shoulder dystocia is defined clinically as difficulty with delivery of the shoulders that was not resolved by the McRoberts' manoeuvre (flexion of the maternal thighs), usually combined with suprapubic pressure. Manoeuvres whose use suggested significant shoulder dystocia were those involving rotation of the fetus to displace the anterior shoulder impacted behind the maternal pubic bone (Woods, Rubin, or Jacquemier manoeuvres). The definition also included births with an interval of 60 s or more between delivery of the head and the body.
Measured: Between 36 weeks and 36 weeks + 6 days of gestation
Comparative prediction rate for maternal morbidity
Ability of Magnetic Resonance-Estimated Fetal Weigth (+/- pelvimetric measurements) vs. Ultrasound-Estimated Fetal Weigth in predicting maternal morbidity, defined as caesarean section, operative vaginal delivery (vacuum or forceps), postpartum haemorrhage (1000 mL or more), blood transfusion, and anal sphincter tear.
Measured: Between 36 weeks and 36 weeks + 6 days of gestation
Comparative prediction rate for neonatal morbidity
Ability of Magentic Resonance-Estimated Fetal Weigth (+/- pelvimetric measurements) vs. Ultrasound-Estimated Fetal Weigth in predicting neonatal morbidity, defined as arterial cord blood pH less than 7.10, Apgar score at 5 min less than 7, and admission to the neonatal intensive-care unit.
Measured: Between 36 weeks and 36 weeks + 6 days of gestation
Comparative prediction rate for neonatal hyperbilirubinaemia
Ability of Magentic Resonance-Estimated Fetal Weigth (+/- pelvimetric measurements) vs. Ultrasound-Estimated Fetal Weigth in predicting neonatal hyperbilirubinaemia, defined as a maximum value exceeding 350 mmol/L of blood bilirubin.
Measured: Between 36 weeks and 36 weeks + 6 days of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start8 Mar 2016
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Fetal 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2,413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jani Jacques, Brugmann University Hospital
- Investigators
- Jacques Jani, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713568
- Sponsor's protocol ID
- CHUB-PREMACRO
- Status last verified
- Aug 2020
- First submitted
- 15 Mar 2016
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
King JR, Korst LM, Miller DA, Ouzounian JG. Increased composite maternal and neonatal morbidity associated with ultrasonographically suspected fetal macrosomia. J Matern Fetal Neonatal Med. 2012 Oct;25(10):1953-9. doi: 10.3109/14767058.2012.674990. Epub 2012 Apr 17.
PubMed 22439605DeVore GR. The importance of the cerebroplacental ratio in the evaluation of fetal well-being in SGA and AGA fetuses. Am J Obstet Gynecol. 2015 Jul;213(1):5-15. doi: 10.1016/j.ajog.2015.05.024.
PubMed 26113227McIntire DD, Bloom SL, Casey BM, Leveno KJ. Birth weight in relation to morbidity and mortality among newborn infants. N Engl J Med. 1999 Apr 22;340(16):1234-8. doi: 10.1056/NEJM199904223401603.
PubMed 10210706Seravalli V, Baschat AA. A uniform management approach to optimize outcome in fetal growth restriction. Obstet Gynecol Clin North Am. 2015 Jun;42(2):275-88. doi: 10.1016/j.ogc.2015.01.005.
PubMed 26002166Boulvain M, Senat MV, Perrotin F, Winer N, Beucher G, Subtil D, Bretelle F, Azria E, Hejaiej D, Vendittelli F, Capelle M, Langer B, Matis R, Connan L, Gillard P, Kirkpatrick C, Ceysens G, Faron G, Irion O, Rozenberg P; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Induction of labour versus expectant management for large-for-date fetuses: a randomised controlled trial. Lancet. 2015 Jun 27;385(9987):2600-5. doi: 10.1016/S0140-6736(14)61904-8. Epub 2015 Apr 8.
PubMed 25863654Bricker L, Neilson JP. Routine ultrasound in late pregnancy (after 24 weeks gestation). Cochrane Database Syst Rev. 2000;(2):CD001451. doi: 10.1002/14651858.CD001451.
PubMed 10796263Bricker L, Neilson JP, Dowswell T. Routine ultrasound in late pregnancy (after 24 weeks' gestation). Cochrane Database Syst Rev. 2008 Oct 8;(4):CD001451. doi: 10.1002/14651858.CD001451.pub3.
PubMed 18843617Rouse DJ, Owen J, Goldenberg RL, Cliver SP. The effectiveness and costs of elective cesarean delivery for fetal macrosomia diagnosed by ultrasound. JAMA. 1996 Nov 13;276(18):1480-6.
PubMed 8903259Gupta M, Hockley C, Quigley MA, Yeh P, Impey L. Antenatal and intrapartum prediction of shoulder dystocia. Eur J Obstet Gynecol Reprod Biol. 2010 Aug;151(2):134-9. doi: 10.1016/j.ejogrb.2010.03.025. Epub 2010 Apr 27.
PubMed 20427112Zaretsky MV, Reichel TF, McIntire DD, Twickler DM. Comparison of magnetic resonance imaging to ultrasound in the estimation of birth weight at term. Am J Obstet Gynecol. 2003 Oct;189(4):1017-20. doi: 10.1067/s0002-9378(03)00895-0.
PubMed 14586347Malin GL, Bugg GJ, Takwoingi Y, Thornton JG, Jones NW. Antenatal magnetic resonance imaging versus ultrasound for predicting neonatal macrosomia: a systematic review and meta-analysis. BJOG. 2016 Jan;123(1):77-88. doi: 10.1111/1471-0528.13517. Epub 2015 Jul 29.
PubMed 26224221Yudkin PL, Aboualfa M, Eyre JA, Redman CW, Wilkinson AR. New birthweight and head circumference centiles for gestational ages 24 to 42 weeks. Early Hum Dev. 1987 Jan;15(1):45-52. doi: 10.1016/0378-3782(87)90099-5.
PubMed 3816638Hadlock FP, Harrist RB, Carpenter RJ, Deter RL, Park SK. Sonographic estimation of fetal weight. The value of femur length in addition to head and abdomen measurements. Radiology. 1984 Feb;150(2):535-40. doi: 10.1148/radiology.150.2.6691115.
PubMed 6691115Hadlock FP, Harrist RB, Sharman RS, Deter RL, Park SK. Estimation of fetal weight with the use of head, body, and femur measurements--a prospective study. Am J Obstet Gynecol. 1985 Feb 1;151(3):333-7. doi: 10.1016/0002-9378(85)90298-4.
PubMed 3881966Sampson ML, Gounden V, van Deventer HE, Remaley AT. CUSUM-Logistic Regression analysis for the rapid detection of errors in clinical laboratory test results. Clin Biochem. 2016 Feb;49(3):201-7. doi: 10.1016/j.clinbiochem.2015.10.019. Epub 2015 Oct 30.
PubMed 26523981
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Fetal Weight by MR Imaging to PREdict Neonatal MACROsomia (PREMACRO Study)
- ClinicalTrials.gov ID
- NCT02713568
- Acronym / sponsor ID
- CHUB-PREMACRO
- Conditions
- Fetal Macrosomia
- Keywords
- Macrosomia, Magnetic Resonance- Estimated Fetal Weight, Ultrasound-Estimated Fetal Weight, Large-for-date fetus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,413 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 18 Mar 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.
Macrosomia and growth restriction are important causes of perinatal morbidity, at or near to term. However, clear identification of 'at risk' foetuses is difficult and clinical estimates of fetal weight are poor. Historically, ultrasound has been used as a second line in such cases but the accuracy of this imaging modality in the mid- to late third trimester is also limited.
Estimated fetal weight (EFW) is an important part of the clinical assessment and is used to guide obstetric interventions, when a fetus is small or large for dates. It frequently is the single most important component guiding interventions, such as induction of labour or Caesarean section.
Due to the imprecision of ultrasound-derived EFW, particularly in cases of suspected macrosomia in the 3rd trimester, the investigators believe that these estimates should not be used to make important obstetric decisions regarding mode and timing of delivery and that a more accurate method of assessment could produce better outcomes by restricting interventions to those foetuses at greatest risk. Some publications have already demonstrated that magnetic resonance (MR) imaging derived-EFW close to delivery, is more accurate than ultrasound
The goal of the present study is thus to compare the performance of magentic resonance imaging derived-EFW, versus ultrasound derived-EFW at 36 weeks of gestation, regarding the prediction of neonatal macrosomia.
Detailed description
Macrosomia and growth restriction are important causes of perinatal morbidity, at or near to term. However, clear identification of 'at risk' foetuses is difficult and clinical estimates of fetal weight are poor. Historically, ultrasound has been used as a second line in such cases but the accuracy of this imaging modality in the mid- to late third trimester is also limited.
Estimated fetal weight (EFW) is an important part of the clinical assessment and is used to guide obstetric interventions, when a fetus is small or large for dates. When a diagnosis of intra-uterine growth restriction (IUGR) is made, the decision-making process is complex, particularly at very early gestations and involves multiple different factors, including maternal status, cardiotocography, liquor volume and dopplers. However, a large body of research is now available to assist with the management of both early and late-onset intrauterine growth restriction (IUGR) but there is a paucity of evidence to guide clinical practice, once macrosomia has been diagnosed, therefore the EFW is frequently the single most important component guiding interventions, such as induction of labour or Caesarean section.
Fetal macrosomia is associated with a higher incidence of perinatal morbidity, including shoulder dystocia and brachial plexus injury in the fetus and anal sphincter tears, uterine atony and haemorrhage in the mother. A recent multicentre randomised controlled trial appears to confirm the advantages of a policy of induction of labour for suspected macrosomia, demonstrating a clear reduction in the rates of shoulder dystocia and composite perinatal morbidity. However, some earlier but lower quality, observational studies have questioned the benefit of EFW made by ultrasonography in the last trimester, for suspected macrosomia, demonstrating that this practice can increase the risk of caesarean and instrumental delivery, without reducing perinatal morbidity.
Despite this conflicting data and a lack of evidence to support routine third trimester ultrasound, the absence of specific guidance, coupled with concerns regarding perinatal outcomes,mean that obstetricians will increasingly request an ultrasound at around 34-36 weeks gestation to identify foetuses above the 90th or below the 10th centiles. This practice will inevitably lead to increased and potentially harmful interventions based on relatively inaccurate data.
Due to the imprecision of ultrasound-derived EFW, particularly in cases of suspected macrosomia in the 3rd trimester, the investigators believe that these estimates should not be used to make important obstetric decisions regarding mode and timing of delivery and that a more accurate method of assessment could produce better outcomes by restricting interventions to those foetuses at greatest risk. Some publications have already demonstrated that magnetic resonance (MR) imaging derived-EFW close to delivery, is more accurate than ultrasound, with a mean percentage error superior to that of ultrasound and a recent meta-analyses has confirmed this promising accuracy.
The goal of the present study is thus to compare the performance of magentic resonance imaging derived-EFW, versus ultrasound derived-EFW at 36 weeks of gestation, regarding the prediction of neonatal macrosomia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Active comparator | Other: Ultrasound examinationDuring routine third trimester ultrasound scan between 30 weeks and 35 weeks +6 days of gestational age, all women with an apparently normal, live singleton pregnancy, planning to deliver at the investigator's hospital maternity, will be invited to participate in the study. An Ultrasound scan to estimate the fetal weigth will be carried out during the 36th week of gestation. |
| Magnetic Resonance | Experimental | Other: Magnetic resonance examinationDuring routine third trimester ultrasound scan between 30 weeks and 35 weeks +6 days of gestational age, all women with an apparently normal, live singleton pregnancy, planning to deliver at the investigator's hospital maternity, will be invited to participate in the study. A Magnetic Resonance examination to estimate the fetal weigth will be carried out during the 36th week of gestation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects is ≥ 18 years of age and able to provide a written informed consent.
- Subject is a pregnant woman carrying a live singleton fetus at the 36+0-36+6 weeks scan, with no major abnormalities appearing during prenatal imaging with no major abnormalities appearing during prenatal imaging potentially affecting the correct use of the Hadlock formula for US-EFW. Conditions such as congenital diaphragmatic hernia with decreased abdominal circumference could be underestimated by the Hadlock USEFW. Another example is a massive sacro-coccygial teratomas.
- Subject is planning a delivery at our maternity at the University Hospital Brugmann, in Brussels, Belgium.
- Subject is known not to have any contra-indication to undergo an MR imaging examination.
Key exclusion criteria (6 listed)
- Subject is known to have a contra-indication to undergo an MR imaging examination such as: Carrying a pacemaker or a metallic cardiac valve, having metallic material inside the head, having metallic fragments inside the eye following an accident, having any type of implant including ear implant, having a hip prosthesis
- Subject presenting with painful regular uterine contractions or history of ruptured membranes.
- Subjects who are unconscious, severely ill, mentally handicapped or under the age of 18 years.
- If birth occurs before MR and US evaluation.
- If patients delivers outside our local maternity unit.
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 examinationPrenatal Ultrasound examinations will be carried out using transabdominal sonography only by experienced consultants in MFM. Ultrasound-Estimated Fetal Weight will be obtained between 36.0-36.6 weeks of gestation, according to Hadlock et al. Operators performing the Ultrasound-Estimated Fetal Weight will be blinded to the results of Magnetic Resonance-Estimated Fetal Weight. The participants, general practitioners, obstetricians and midwifes of the patients will be aware of the results of Ultrasound-Estimated Fetal Weight which will be used for clinical management. For the primary outcome measure, macrosomia during Ultrasound-Estimated Fetal Weight will be defined as ≥ P95 based on Yudkin et al. For secondary outcome measures, it will be redefined as ≥ P90 or ≥ P99 based on Yudkin. | Other | Ultrasound |
| Magnetic resonance examinationMRI will be performed the same day as the Ultrasound examination, using a clinical 1.5T whole-body unit. Operators performing Fetal Body Volume measurements will be blinded from Ultrasound-Estimated Fetal Weight results. Magnetic Resonance-Estimated Fetal Weight will be calculated using the equation 0,12+1,031*Fetal Body Volume = MR imaging weight (g) developed by Baker. General practitioners, obstetricians and midwifes of the patients will be blinded to the results of the Magnetic Resonance-Estimated Fetal Weight. For the primary outcome measure, macrosomia will be defined as ≥ P95 based on Yudkin et al. For secondary outcome measures, it will be defined as ≥ P90 or ≥ P99. | Other | Magnetic Resonance |
Primary outcome
Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (≥ P95)
Time frame: Between 36 weeks and 36 weeks + 6 days of gestation
AUROC for prediction of macrosomia (≥ P95 for gestational age; normal ranges of Yudkin et al.) with MR (4 mm ST (slice thickness)/ 20 mm gap) versus US using the Hadlock equation.
9 secondary outcomes
Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (≥ P90)
Time frame: Between 36 weeks and 36 weeks + 6 days of gestation
Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (≥ P99)
Time frame: Between 36 weeks and 36 weeks + 6 days of gestation
Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (≥ P97)
Time frame: Between 36 weeks and 36 weeks + 6 days of gestation
Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (Abdominal Circumference)
Time frame: Between 36 weeks and 36 weeks + 6 days of gestation
Area Under the Receiver Operating Curve (AUROC) for prediction of 'Small for gestational age' (SGA)
Time frame: Between 36 weeks and 36 weeks + 6 days of gestation
Comparative prediction rate for significant shoulder dystocia
Time frame: Between 36 weeks and 36 weeks + 6 days of gestation
Comparative prediction rate for maternal morbidity
Time frame: Between 36 weeks and 36 weeks + 6 days of gestation
Comparative prediction rate for neonatal morbidity
Time frame: Between 36 weeks and 36 weeks + 6 days of gestation
Comparative prediction rate for neonatal hyperbilirubinaemia
Time frame: Between 36 weeks and 36 weeks + 6 days of gestation
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 6 Aug 2020.
- Background: PubMed 22439605King JR, Korst LM, Miller DA, Ouzounian JG. Increased composite maternal and neonatal morbidity associated with ultrasonographically suspected fetal macrosomia. J Matern Fetal Neonatal Med. 2012 Oct;25(10):1953-9. doi: 10.3109/14767058.2012.674990. Epub 2012 Apr 17.
- Background: PubMed 26113227DeVore GR. The importance of the cerebroplacental ratio in the evaluation of fetal well-being in SGA and AGA fetuses. Am J Obstet Gynecol. 2015 Jul;213(1):5-15. doi: 10.1016/j.ajog.2015.05.024.
- Background: PubMed 10210706McIntire DD, Bloom SL, Casey BM, Leveno KJ. Birth weight in relation to morbidity and mortality among newborn infants. N Engl J Med. 1999 Apr 22;340(16):1234-8. doi: 10.1056/NEJM199904223401603.
- Background: PubMed 26002166Seravalli V, Baschat AA. A uniform management approach to optimize outcome in fetal growth restriction. Obstet Gynecol Clin North Am. 2015 Jun;42(2):275-88. doi: 10.1016/j.ogc.2015.01.005.
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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.
Jacques Jani, MD principal investigator
CHU Brugmann
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 examination and Magnetic resonance examination in people with Fetal Macrosomia, run by Brugmann University Hospital at 1 site in Belgium.
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: finished, as of the sponsor's last update on 6 Aug 2020. 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 Belgium. 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?
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?
Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (≥ P95) (time frame: Between 36 weeks and 36 weeks + 6 days of gestation). 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 NCT02713568, which also lists 21 linked publications.
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 6 Aug 2020.