Fetal Growth RetardationSAVEFGRNCT06010238
STV Analysis Versus Visual Evaluation of Cardiotocography in FGR
A study testing Short term variation and Visual interpretation in people with Fetal Growth Retardation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 6 sites in Netherlands.
Trial summary
This stepped wedge cluster randomized clinical trial investigates whether in pregnant women with severe, early-onset fetal growth restriction, the use of STV analysis in fetal monitoring improves the chances of perinatal survival, compared with visual evaluation of the cardiotocography. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Fetal Growth Retardation
- What is being tested?
- Short term variation and Visual interpretation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 6 sitesNetherlands
- Study dates
- 18 Jun 2025to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women with a singleton pregnancy between 24 weeks and 0 days and 31 weeks and 6 days with severe, early-onset fetal growth restriction, admitted in hospital or frequently evaluated ambulatory by CTG (according to local protocol) for fetal monitoring.
- Fetal growth restriction is defined in line with the international Delphi consensus as biometric ultrasound measurement of the abdominal circumference (AC) OR a combination of measurements resulting in an estimated fetal weight (EFW) below the 3rd percentile (<p3) OR a combination of EFW <p10 AND uterine artery pulsatility index (PI) >p95 OR umbilical artery Doppler PI >p95.
- Maternal age ≥ 18 years.
- Able to provide written informed consent for collection and use of data on informed consent form in available language.
Who cannot join
- Known congenital or chromosomal anomalies influencing perinatal outcome.
- Imminent labour or expected maternal indication for delivery < 48 hours.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Netherlands6 sites, 6 recruiting
- Not yet recruiting
Amsterdam University Medical Center
Amsterdam
M. E. Bruins, +3120 566 9111, m.e.bruins@amsterdamumc.nl
- Recruiting
University Medical Center Groningen
Groningen, Provincie Groningen
Mariëlle E. Bruins, +31 50 361 6161, m.e.bruins@umcg.nl
- Not yet recruiting
Maastricht University Medical Center+
Maastricht
M. E. Bruins, +3120 566 9111, m.e.bruins@amsterdamumc.nl
- Not yet recruiting
Radboud University Medical Center
Nijmegen
M. E. Bruins, +3120 566 9111, m.e.bruins@amsterdamumc.nl
- Not yet recruiting
Erasmus MC University Medical Center
Rotterdam
M. E. Bruins, +3120 566 9111, m.e.bruins@amsterdamumc.nl
- Not yet recruiting
Isala
Zwolle
M. E. Bruins, +3120 566 9111, m.e.bruins@umcg.nl
About this study
Official title: Short Term Variation Analysis Versus Visual Evaluation of Cardiotocography in Fetal Growth Restriction
This stepped wedge cluster randomized clinical trial investigates whether in pregnant women with severe, early-onset fetal growth restriction, the use of STV analysis in fetal monitoring improves the chances of perinatal survival, compared with visual evaluation of the cardiotocography.
Read the detailed description
Severe, early-onset fetal growth restriction (FGR, <32 weeks gestation) is a condition in which the fetus does not reach its growth potential due to placental insufficiency[. This condition affects about 0.3% of pregnancies, accounting for an estimated 15,000 babies in Europe being born premature below 32 weeks gestation. The main clinical dilemma of FGR lies in the timing of birth, given the balance of risks of antenatal mortality and severe damage to organs and the aggravated neonatal effects of prematurity: death or survival with severe neurodevelopmental impairment. The mainstay of clinical management in these cases pivots around the anticipation of the risk of fetal demise from placental oxygenation failure. The monitoring variables that are currently available comprise assessment of the severity of metabolic insufficiency (fetal size and growth, Doppler ultrasound, serum biomarkers) and the early detection of progressive fetal hypoxia with cardiotocography (CTG). The common approach is to deliver the fetus when signs of advanced hypoxia appear on CTG. A delicate balance exists between having the fetus born (too) early and facing the risks of extreme prematurity combined with a very low birthweight; and between delivering the fetus (too) late when the fetus has the disadvantage of hypoxia at birth. The decision when to deliver the fetus, is made mostly based on the CTG. The inter- and intra-observer variability could be overcome by software analysis according to the original Dawes\&Redman algorithm. The software calculates the short-term variation (STV) of the inter-beat interval expressed in milliseconds, and a range of secondary calculations. In contrast with repeated decelerations, when fetal hypoxia is considered evident, the place of the software analysis of the fetal heart rate variability is less clear. Although the advantages of mathematized and uniform quantification of the fetal heart rate variability appear self-evident, there are no studies with sufficient power to detect an association of intervention based on STV at any threshold with the most important outcomes: fetal death and long-term infant outcome.
The purpose of this study is to assess the outcomes of monitoring the fetal condition with STV in computerized CTG compared to visual interpretation of the CTG in order to time delivery in pregnant women with severe, early-onset FGR.
- Conditions
- Fetal Growth Retardation
- Being tested
- Short term variation, Visual interpretation
- Keywords
- fetal growth restriction, cardiotocography, perinatal death, short term variation
- Medical subject headings
- Fetal Growth Retardation, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short term variationDevice
Short term variation in computer software analysis
Visual interpretationDevice
Visual interpretation of cardiotocography
| Study group | Role | What they receive |
|---|---|---|
| Visual interpretation of cardiotocography | Active comparator | Monitoring by visual interpretation of cardiotocography Receives: Device: Visual interpretation |
| Short term variation | Experimental | Short term variation by computer software analysis Receives: Device: Short term variation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of pregnancies resulting in perinatal death
Perinatal death is defined as antenatal death or neonatal/infant death before discharge from NICU
Measured: Before discharge from neonatal intensive care unit (NICU), up to 1 year
Secondary outcomes (3)
Proportion of children with major neonatal morbidity
Major neonatal morbidity is a composite outcome defined as intraventricular hemorrhage grade 3 or more, periventricular leukomalacia grade 2 or more, moderate or severe bronchopulmonary dysplasia, necrotizing enterocolitis Bell stage 2 or more, or retinopathy of prematurity requiring therapy.
Measured: Before discharge from NICU, up to 1 year
Proportion of children with neonatal morbidities
Individual neonatal morbidities of the abovementioned composite outcome and additionally persisting ductus arteriosus, persistent pulmonary hypertension of the newborn (PPHN), respiratory distress syndrome (RDS), period of invasive mechanical ventilation in days, medication need, hypoglycaemia, neonatal jaundice, sepsis and cardiovascular function.
Measured: Before discharge from NICU, up to 1 year
Proportion of children with neurodevelopmental impairment
Neurodevelopmental impairment is defined as an abnormal test on Bayley III Dutch version (or version IV if available) (composite cognitive score < 85, composite motor score < 85), cerebral palsy, with a Gross Motor Function Classification System (GMFCS) grade > 1, hearing loss needing hearing aids, or severe visual loss (legally certifiable as blind or partially sighted) assessed at two years of corrected age
Measured: At two years of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start18 Jun 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped wedge cluster randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wessel Ganzevoort, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Wessel Ganzevoort, MD PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010238
- Sponsor's protocol ID
- 84591
- Acronym
- SAVEFGR
- Status last verified
- Nov 2026
- First submitted
- 21 Jul 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan, but data will be available upon collaboration request
Publications
Bruins ME, Prins LI, Pels A, Groen H, Lokkegaard ECL, Jacquemyn Y, Scholz A, Onland W, Leemhuis AG, Papageorghiou AT, Figueras F, Gordijn SJ, Ganzevoort W. The SAVE FGR study: Short term variation Analysis versus Visual Evaluation of cardiotocography in early-onset Fetal Growth Restriction to trigger expedited birth - study protocol for a stepped wedge cluster randomized trial. BMC Pregnancy Childbirth. 2026 Feb 21;26(1):343. doi: 10.1186/s12884-026-08695-0.
PubMed 41723364
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Variation Analysis Versus Visual Evaluation of Cardiotocography in Fetal Growth Restriction
- ClinicalTrials.gov ID
- NCT06010238
- Acronym / sponsor ID
- SAVEFGR / 84591
- Conditions
- Fetal Growth Retardation
- Keywords
- fetal growth restriction, cardiotocography, perinatal death, short term variation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 24 Aug 2023 (actual)
- 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.
This stepped wedge cluster randomized clinical trial investigates whether in pregnant women with severe, early-onset fetal growth restriction, the use of STV analysis in fetal monitoring improves the chances of perinatal survival, compared with visual evaluation of the cardiotocography.
Detailed description
Severe, early-onset fetal growth restriction (FGR, <32 weeks gestation) is a condition in which the fetus does not reach its growth potential due to placental insufficiency[. This condition affects about 0.3% of pregnancies, accounting for an estimated 15,000 babies in Europe being born premature below 32 weeks gestation. The main clinical dilemma of FGR lies in the timing of birth, given the balance of risks of antenatal mortality and severe damage to organs and the aggravated neonatal effects of prematurity: death or survival with severe neurodevelopmental impairment. The mainstay of clinical management in these cases pivots around the anticipation of the risk of fetal demise from placental oxygenation failure. The monitoring variables that are currently available comprise assessment of the severity of metabolic insufficiency (fetal size and growth, Doppler ultrasound, serum biomarkers) and the early detection of progressive fetal hypoxia with cardiotocography (CTG). The common approach is to deliver the fetus when signs of advanced hypoxia appear on CTG. A delicate balance exists between having the fetus born (too) early and facing the risks of extreme prematurity combined with a very low birthweight; and between delivering the fetus (too) late when the fetus has the disadvantage of hypoxia at birth. The decision when to deliver the fetus, is made mostly based on the CTG. The inter- and intra-observer variability could be overcome by software analysis according to the original Dawes\&Redman algorithm. The software calculates the short-term variation (STV) of the inter-beat interval expressed in milliseconds, and a range of secondary calculations. In contrast with repeated decelerations, when fetal hypoxia is considered evident, the place of the software analysis of the fetal heart rate variability is less clear. Although the advantages of mathematized and uniform quantification of the fetal heart rate variability appear self-evident, there are no studies with sufficient power to detect an association of intervention based on STV at any threshold with the most important outcomes: fetal death and long-term infant outcome.
The purpose of this study is to assess the outcomes of monitoring the fetal condition with STV in computerized CTG compared to visual interpretation of the CTG in order to time delivery in pregnant women with severe, early-onset FGR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge cluster randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Visual interpretation of cardiotocography | Active comparator | Device: Visual interpretationMonitoring by visual interpretation of cardiotocography |
| Short term variation | Experimental | Device: Short term variationShort term variation by computer software analysis |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women with a singleton pregnancy between 24 weeks and 0 days and 31 weeks and 6 days with severe, early-onset fetal growth restriction, admitted in hospital or frequently evaluated ambulatory by CTG (according to local protocol) for fetal monitoring.
- Fetal growth restriction is defined in line with the international Delphi consensus as biometric ultrasound measurement of the abdominal circumference (AC) OR a combination of measurements resulting in an estimated fetal weight (EFW) below the 3rd percentile (<p3) OR a combination of EFW <p10 AND uterine artery pulsatility index (PI) >p95 OR umbilical artery Doppler PI >p95.
- Maternal age ≥ 18 years.
- Able to provide written informed consent for collection and use of data on informed consent form in available language.
Key exclusion criteria (2 listed)
- Known congenital or chromosomal anomalies influencing perinatal outcome.
- Imminent labour or expected maternal indication for delivery < 48 hours.
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 |
|---|---|---|
| Short term variationShort term variation in computer software analysis | Device | Short term variation |
| Visual interpretationVisual interpretation of cardiotocography | Device | Visual interpretation of cardiotocography |
Primary outcome
Proportion of pregnancies resulting in perinatal death
Time frame: Before discharge from neonatal intensive care unit (NICU), up to 1 year
Perinatal death is defined as antenatal death or neonatal/infant death before discharge from NICU
3 secondary outcomes
Proportion of children with major neonatal morbidity
Time frame: Before discharge from NICU, up to 1 year
Proportion of children with neonatal morbidities
Time frame: Before discharge from NICU, up to 1 year
Proportion of children with neurodevelopmental impairment
Time frame: At two years of corrected age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Derived from this study: PubMed 41723364Bruins ME, Prins LI, Pels A, Groen H, Lokkegaard ECL, Jacquemyn Y, Scholz A, Onland W, Leemhuis AG, Papageorghiou AT, Figueras F, Gordijn SJ, Ganzevoort W. The SAVE FGR study: Short term variation Analysis versus Visual Evaluation of cardiotocography in early-onset Fetal Growth Restriction to trigger expedited birth - study protocol for a stepped wedge cluster randomized trial. BMC Pregnancy Childbirth. 2026 Feb 21;26(1):343. doi: 10.1186/s12884-026-08695-0.
- Individual participant dataSharing planned: No. There is no current plan, but data will be available upon collaboration request
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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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.
Wessel Ganzevoort, MD PhD principal investigator
Amsterdam UMC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short term variation and Visual interpretation in people with Fetal Growth Retardation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 6 sites in Netherlands.
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 2 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wessel Ganzevoort, MD PhD (003120-5669111, j.w.ganzevoort@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of pregnancies resulting in perinatal death (time frame: Before discharge from neonatal intensive care unit (NICU), up to 1 year). 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 NCT06010238, which also lists 1 linked publication.
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 4 Nov 2026.