Estimation of Fetal Weight by MR Imaging to PREdict Neonatal MACROsomia (PREMACRO Study)

NCT02713568 | Completed

• 1 other identifier: CHUB-PREMACRO
• Study Type: interventional
• Target: 2,413
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fetal Macrosomia

Keywords

Macrosomia; Magnetic Resonance- Estimated Fetal Weight; Ultrasound-Estimated Fetal Weight; Large-for-date fetus

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Between 36 weeks and 36 weeks + 6 days of gestation

• Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (≥ P99)

  Between 36 weeks and 36 weeks + 6 days of gestation

• Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (≥ P97)

  Between 36 weeks and 36 weeks + 6 days of gestation

• Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (Abdominal Circumference)

  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)

  Between 36 weeks and 36 weeks + 6 days of gestation

Study Arms (2)

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.

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.

Other: Magnetic resonance examination

Interventions

Ultrasound examination OTHER

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.

Ultrasound

Magnetic resonance examination OTHER

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.

Magnetic Resonance

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (21)

• 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.

  PMID: 22439605 BACKGROUND

• DeVore 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.

  PMID: 26113227 BACKGROUND

• McIntire 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.

  PMID: 10210706 BACKGROUND

• Seravalli 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.

  PMID: 26002166 BACKGROUND

• Boulvain 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.

  PMID: 25863654 BACKGROUND

• Bricker L, Neilson JP. Routine ultrasound in late pregnancy (after 24 weeks gestation). Cochrane Database Syst Rev. 2000;(2):CD001451. doi: 10.1002/14651858.CD001451.

  PMID: 10796263 BACKGROUND

• Bricker 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.

  PMID: 18843617 BACKGROUND

• Rouse 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.

  PMID: 8903259 BACKGROUND

• Gupta 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.

  PMID: 20427112 BACKGROUND

• Zaretsky 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.

  PMID: 14586347 BACKGROUND

• Malin 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.

  PMID: 26224221 BACKGROUND

• Yudkin 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.

  PMID: 3816638 BACKGROUND

• Hadlock 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.

  PMID: 6691115 BACKGROUND

• Hadlock 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.

  PMID: 3881966 BACKGROUND

• Sampson 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.

  PMID: 26523981 BACKGROUND

• Wani S, Hall M, Wang AY, DiMaio CJ, Muthusamy VR, Keswani RN, Brauer BC, Easler JJ, Yen RD, El Hajj I, Fukami N, Ghassemi KF, Gonzalez S, Hosford L, Hollander TG, Wilson R, Kushnir VM, Ahmad J, Murad F, Prabhu A, Watson RR, Strand DS, Amateau SK, Attwell A, Shah RJ, Early D, Edmundowicz SA, Mullady D. Variation in learning curves and competence for ERCP among advanced endoscopy trainees by using cumulative sum analysis. Gastrointest Endosc. 2016 Apr;83(4):711-9.e11. doi: 10.1016/j.gie.2015.10.022. Epub 2015 Oct 26.

  PMID: 26515957 BACKGROUND

• Baker PN, Johnson IR, Gowland PA, Hykin J, Harvey PR, Freeman A, Adams V, Worthington BS, Mansfield P. Fetal weight estimation by echo-planar magnetic resonance imaging. Lancet. 1994 Mar 12;343(8898):644-5. doi: 10.1016/s0140-6736(94)92638-7.

  PMID: 7906814 BACKGROUND

• DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45.

  PMID: 3203132 BACKGROUND

• Leisenring W, Alonzo T, Pepe MS. Comparisons of predictive values of binary medical diagnostic tests for paired designs. Biometrics. 2000 Jun;56(2):345-51. doi: 10.1111/j.0006-341x.2000.00345.x.

  PMID: 10877288 BACKGROUND

• Kadji C, Cannie MM, Carlin A, Jani JC. Protocol for the prospective observational clinical study: estimation of fetal weight by MRI to PREdict neonatal MACROsomia (PREMACRO study) and small-for-gestational age neonates. BMJ Open. 2019 Mar 27;9(3):e027160. doi: 10.1136/bmjopen-2018-027160.

  PMID: 30918039 DERIVED

• Kadji C, Cannie MM, Resta S, Guez D, Abi-Khalil F, De Angelis R, Jani JC. Magnetic resonance imaging for prenatal estimation of birthweight in pregnancy: review of available data, techniques, and future perspectives. Am J Obstet Gynecol. 2019 May;220(5):428-439. doi: 10.1016/j.ajog.2018.12.031. Epub 2018 Dec 22.

  PMID: 30582928 DERIVED

MeSH Terms

Conditions

Fetal Macrosomia

Condition Hierarchy (Ancestors)

Diabetes, Gestational; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Pregnancy in Diabetics; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Birth Weight; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacques Jani, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 18, 2016
• Study Start: March 8, 2016
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-08

Locations

BE (1)