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Published on: June 29, 2013
A Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints: the COSGROVE
Patricia Healy1, Sanne J Gordijn2, Wessel Ganzevoort3
1Health Research Board-Trials Methodology Research Network and the School of Nursing and Midwifery, National University of Ireland, Galway, Ireland.
Insights
A core outcome set was developed to standardize measurements in fetal growth restriction trials. This ensures consistent reporting and comparison of results for better prevention and treatment strategies.
Area of Science:
- Obstetrics and Gynecology
- Perinatology
- Clinical Trial Methodology
Background:
- Fetal growth restriction (FGR) impacts a fetus's ability to reach its genetic growth potential.
- FGR is linked to increased risks of adverse short- and long-term health outcomes.
- Variability in outcome reporting complicates evidence synthesis from FGR clinical trials.
Purpose of the Study:
- To establish standardized core outcome sets for clinical trials focused on the prevention or treatment of FGR.
Main Methods:
- A Delphi consensus study was employed, involving a literature review to identify reported outcomes.
- Stakeholders including healthcare providers, researchers, and the public participated in three rounds of online surveys.
- Consensus was achieved through predefined criteria at a face-to-face meeting.
Main Results:
- A final core outcome set comprising 22 outcomes was established.
- These outcomes are categorized into maternal (4), fetal (1), neonatal (12), and childhood (5) domains.
Conclusions:
- The Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints (COS-FGROwth) study provides a minimum standard for outcome measurement in FGR trials.
- Standardized measurement and reporting will enhance the comparability and combined analysis of findings across studies.
- This facilitates more robust evidence generation for FGR interventions.
Background:
Fetal growth restriction refers to a fetus that does not reach its genetically predetermined growth potential. It is well-recognized that growth-restricted fetuses are at increased risk of both short- and long-term adverse outcomes. Systematic evaluation of the evidence from clinical trials of fetal growth restriction is often difficult because of variation in the outcomes that are measured and reported. The development of core outcome sets for fetal growth restriction studies would enable future trials to measure similar meaningful outcomes.
Objective:
The purpose of this study was to develop core outcome sets for trials of prevention or treatment of fetal growth restriction.
Study Design:
This was a Delphi consensus study. A comprehensive literature review was conducted to identify outcomes that were reported in studies of prevention or treatment of fetal growth restriction. All outcomes were presented for prioritization to key stakeholders (135 healthcare providers, 68 researchers/academics, and 35 members of the public) in 3 rounds of online Delphi surveys. A priori consensus criteria were used to reach agreement on the final outcomes for inclusion in the core outcome set at a face-to-face meeting with 5 healthcare providers, 5 researchers/academics, and 6 maternity service users.
Results:
In total, 22 outcomes were included in the final core outcome set. These outcomes were grouped under 4 domains: maternal (n=4), fetal (n=1), neonatal (n=12), and childhood (n=5).
Conclusion:
The Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints study identified a large number of potentially relevant outcomes and then reached consensus on those factors that, as a minimum, should be measured and reported in all future trials of prevention or treatment of fetal growth restriction. This will enable future trials to measure similar meaningful outcomes and to ensure that findings from different studies can be compared and combined.
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