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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed 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. 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 pra
Sponsor: Brugmann University Hospital

Current 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (≥ P90) [ Time Frame: Between 36 weeks and 36 weeks + 6 days of gestation ]
  AUROC for prediction of macrosomia (≥ P90 for gestational age) with magnetic resonnance (4 mm slice thickness/20 mm gap) versus ultrasound.
• Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (≥ P99) [ Time Frame: Between 36 weeks and 36 weeks + 6 days of gestation ]
  AUROC for prediction of macrosomia (≥ P99 for gestational age) with Magnetic Resonance (4 mm slice thickness/ 20 mm gap) versus Ultrasound.
• Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (≥ P97) [ Time Frame: Between 36 weeks and 36 weeks + 6 days of gestation ]
  AUROC for prediction of macrosomia (≥ P97 for gestational age) with Magnetic Resonance (4 mm slice thickness/ 20 mm gap) versus Ultrasound.
• 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 ]
  AUROC for prediction of macrosomia with Abdominal Circumference ≥ P90 for gestational age. Measured in cm with Ultrasound
• 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 ]
  Measured with Magnetic Resonnace (4 mm slice thickness)/ 20 mm gap) versus ultrasound.
• Comparative prediction rate for significant shoulder dystocia [ Time Frame: Between 36 weeks and 36 weeks + 6 days of gestation ]
  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.
• Comparative prediction rate for maternal morbidity [ Time Frame: Between 36 weeks and 36 weeks + 6 days of gestation ]
  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.
• Comparative prediction rate for neonatal morbidity [ Time Frame: Between 36 weeks and 36 weeks + 6 days of gestation ]
  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.
• Comparative prediction rate for neonatal hyperbilirubinaemia [ Time Frame: Between 36 weeks and 36 weeks + 6 days of gestation ]
  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.

Original Secondary Outcome:

• Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (≥ P90) [ Time Frame: Between 36 weeks and 36 weeks + 6 days of gestation ]
  AUROC for prediction of macrosomia (≥ P90 for gestational age) with magnetic resonnance (4 mm slice thickness/20 mm gap) versus ultrasound.
• Area Under the Receiver Operating Curve (AUROC) for prediction of macrosomia (≥ P99) [ Time Frame: Between 36 weeks and 36 weeks + 6 days of gestation ]
  AUROC for prediction of macrosomia (≥ P99 for gestational age) with Magnetic Resonance (4 mm slice thickness/ 20 mm gap) versus Ultrasound.
• 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 ]
  AUROC for prediction of macrosomia with Abdominal Circumference ≥ P90 for gestational age. Measured in cm with Ultrasound
• 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 ]
  Measured with Magnetic Resonnace (4 mm slice thickness)/ 20 mm gap) versus ultrasound.
• Comparative prediction rate for significant shoulder dystocia [ Time Frame: Between 36 weeks and 36 weeks + 6 days of gestation ]
  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.
• Comparative prediction rate for maternal morbidity [ Time Frame: Between 36 weeks and 36 weeks + 6 days of gestation ]
  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.
• Comparative prediction rate for neonatal morbidity [ Time Frame: Between 36 weeks and 36 weeks + 6 days of gestation ]
  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.
• Comparative prediction rate for neonatal hyperbilirubinaemia [ Time Frame: Between 36 weeks and 36 weeks + 6 days of gestation ]
  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.

Dates:
Date Received: March 15, 2016
Date Started: May 2016
Date Completion: April 2018
Last Updated: July 25, 2016
Last Verified: July 2016