Fetal monitoring indications for delivery and 2-year outcome in 310 infants with fetal growth restriction delivered before 32 weeks' gestation in the TRUFFLE study
Open accessAbstract
Objective: In the TRUFFLE (Trial of Randomized Umbilical and Fetal Flow in Europe) study on the outcome of early fetal growth restriction, women were allocated to one of three groups of indication for delivery according to the following monitoring strategies: (1) reduced fetal heart rate (FHR) short‐term variation (STV) on cardiotocography (CTG); (2) early changes in fetal ductus venosus (DV) waveform (DV‐p95); and (3) late changes in fetal DV waveform (DV‐no‐A). However, many infants per monitoring protocol were delivered because of safety‐net criteria, for maternal or other fetal indications, or after 32 weeks of gestation when the protocol was no longer applied. The objective of the present posthoc subanalysis was to investigate the indications for delivery in relation to 2‐year outcome in infants delivered before 32 weeks to further refine management proposals. Methods: We included all 310 cases of the TRUFFLE study with known outcome at 2 years' corrected age and seven fetal deaths, excluding seven cases with inevitable perinatal death. Data were analyzed according to the allocated fetal monitoring strategy in combination with the indication for delivery. Results: Overall, only 32% of liveborn infants were delivered according to the specified monitoring parameter for indication for delivery; 38% were delivered because of safety‐net criteria, 15% for other fetal reasons and 15% for maternal reasons. In the CTG‐STV group, 51% of infants were delivered because of reduced STV. In the DV‐p95 group, 34% of infants were delivered because of abnormal DV and, in the DV‐no‐A group, only 10% of infants were delivered accordingly. The majority of infants in the DV groups were delivered for the safety‐net criterion of spontaneous decelerations in FHR. Two‐year intact survival was highest in the DV groups combined compared with the CTG‐STV group (P = 0.05 for live births only, P = 0.21 including fetal death), with no difference between DV groups. A poorer outcome in the CTG‐STV group was restricted to infants delivered because of FHR decelerations in the safety‐net subgroup. Infants delivered because of maternal reasons had the highest birth weight and a non‐significantly higher intact survival. Conclusions: In this subanalysis of infants delivered before 32 weeks, the majority were delivered for reasons other than the allocated monitoring strategy indication. Since, in the DV group, CTG‐STV criteria were used as a safety net but in the CTG‐STV group, no DV safety‐net criteria were applied, we speculate that the slightly poorer outcome in the CTG‐STV group might be explained by the absence of DV data. The optimal timing of delivery of fetuses with early intrauterine growth restriction may therefore be best determined by monitoring them longitudinally, with both DV and CTG monitoring. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.
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In TRUFFLE, delivery decisions guided by ductus venosus Doppler findings accounted for about 11% of pregnancies allocated to the late ductus venosus findings group because most delivered due to other fetal or maternal indications.
“In TRUFFLE, delivery decisions guided by ductus venosus Doppler findings only accounted for about 11% of pregnancies allocated to the late ductus venosus findings group because most delivered due to other fetal or maternal indications.115,120,121”
From Society for Maternal-Fetal Medicine Consult Series #52: Diagnosis and management of fetal growth restriction (2020) · cites this paper as [121]
The Results report that 10% of cases in the late ductus venosus (DV-no-A) group were delivered for the allocated Doppler finding, consistent with 'about 11%.' But they say more than 50% were delivered because of safety-net criteria and almost 40% for other fetal or maternal indications. The claim incorrectly makes the latter the majority reason. (LLM, conf=0.92)
Experimental — accuracy not yet measuredThe presence of spontaneous repetitive late decelerations is accepted as an indication for delivery in viable pregnancies with FGR, irrespective of Doppler findings.
“the presence of spontaneous repetitive late decelerations is accepted as an indication for delivery in viable pregnancies with FGR, irrespective of Doppler findings”
From Society for Maternal-Fetal Medicine Consult Series #52: Diagnosis and management of fetal growth restriction (2020) · cites this paper as [121]
The Methods describe recurrent fetal-heart-rate decelerations as a delivery safety-net criterion in all three monitoring groups, including the groups monitored by ductus venosus Doppler. The paper does not specify that these were *late* decelerations, and its study population was pregnancies with very preterm fetal growth restriction at 26–32 weeks, not viable FGR pregnancies generally. The cited copy provides no page number for the Methods passage. (LLM, conf=0.85)
Experimental — accuracy not yet measuredA normal CTG in pregnancies with FGR is more likely to be associated with a normal perinatal outcome.
“a normal CTG in pregnancies with FGR is more likely to be associated with a normal perinatal outcome”
From Society for Maternal-Fetal Medicine Consult Series #52: Diagnosis and management of fetal growth restriction (2020) · cites this paper as [121]
The Results (page not available) report that 80% of infants delivered because of CTG abnormalities were normal at follow-up. Our copy does not compare outcomes after normal versus abnormal CTG, so it does not establish the claimed association; searches for normal CTG and outcomes found no such comparison. (LLM, conf=0.70)
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References 15 · Cited by 51
Research works printed but not linked: 1
- [6]6. Nijhuis IJM, ten Hof J, Mulder EJH, Nijhuis JG, Narayan H, Taylor DJ, Visser GHA. Numerical fetal heart rate analysis: nomograms, minimal duration of recording and intrafetal consistency. Prenat Neonat Med 1998; 3: 314-322.
- Authors
- Visser, G. H. A., Bilardo, C. M., Derks, J. B., Ferrazzi, E., Fratelli, N., Frusca, T., Ganzevoort, W., Lees, C. C., Napolitano, R., Todros, T., Wolf, H., Hecher, K., & TRUFFLE group investigators
- Affiliations
- University Medical Center Utrecht (NL)
- University Medical Center Groningen (NL)
- University of Milan (IT)
- University of Brescia (IT)
- Department of Obstetrics and Gynecology University Hospital Parma Italy
- Amsterdam UMC Location University of Amsterdam (NL)
- Imperial College London (GB)
- Federico II University Hospital (IT)
- Ospedale Sant'Anna (IT)
- University Medical Center Hamburg-Eppendorf (DE)
- Corresponding author
- Visser, G. H. A.
- ORCID
- Venue
- Ultrasound in Obstetrics & Gynecology
- Publisher
- Wiley
- Published
- 2017-09
- Volume
- 50
- Issue
- 3
- Pages
- 347-352
- ISSN
- 0960-7692 (ISSN-L)
- 1469-0705
- OpenAlex
- W2755097833
- Semantic Scholar
- db8b38a7f089d5aac78a26dd79b5a97640d2667a
- Cited by
- 51
- References
- 15
- Citations by year
- 2026: 5 · 2025: 3 · 2024: 6 · 2023: 4 · 2022: 4 · 2021: 11 · 2020: 3 · 2019: 6 · 2018: 7 · 2017: 2
- FWCI
- 6.45
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Ultrasound in Obstetrics and Gynecology (publishedVersion)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, other-oa)
- St George's Online Research Archive (St George's University of London) (acceptedVersion)
- Pure Amsterdam UMC (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Cineca Institutional Research Information System (Tor Vergata University) (submittedVersion)
- Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
- UCL Discovery (University College London) (submittedVersion)
- Institutional Research Information System (Università degli Studi di Brescia) (submittedVersion, other-oa)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion, other-oa)
- Spiral (Imperial College London) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- Utrecht University Repository (Utrecht University) (submittedVersion)
- Funders
- Friedrich-Schiller-Universität Jena
- KU Leuven
- Università degli Studi di Brescia
- Universitätsklinikum Hamburg-Eppendorf
- Topics
- Health Sciences › Medicine › Obstetrics and Gynecology › Pregnancy and preeclampsia studies
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Cardiovascular Conditions and Treatments
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Birth, Development, and Health
- Keywords
- fetal growth restriction, preterm birth, fetal heart rate variability, cardiotocography, fetal monitoring, neonatal survival, umbilical artery Doppler, fetal death, fetal heart rate decelerations, birth weight, gestational age at delivery
- MeSH terms
- Female, Fetal Growth Retardation, Fetal Monitoring, Fetus, Gestational Age, Humans, Infant, Newborn, Male, Netherlands, Pregnancy, Pregnancy Outcome, Pulsatile Flow, Umbilical Arteries, Cardiotocography, Survival Analysis, Ultrasonography, Prenatal, Delivery, Obstetric
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