The purpose of this study is to assess the outcomes of monitoring the fetal condition with STV in cCTG compared to visual interpretation of the CTG in order to time delivery in pregnant women with severe, early-onset FGR.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is perinatal death, defined as antenatal
death or neonatal/infant death before discharge from NICU. Our hypothesis is
that in the pregnant women monitored by STV in cCTG, a decrease in the primary
outcome will be observed, compared with pregnant women monitored by visual
interpretation of CTG.
Secondary outcome
•Major neonatal morbidity until discharge home. 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.
•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.
•Neurodevelopmental impairment, 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, where available by local protocol.
•ASQ, physical growth and Lexilijst, in addition to neurodevelopmental outcome
measures.
•Delivery characteristics including Apgar scores and umbilical cord pH.
•All remaining outcomes required by the core outcome set for fetal growth
restriction will also be collected.
•Serum biomarkers and fetal electrocardiography, when available.
Background summary
Severe, early-onset fetal growth restriction (FGR) 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 intricate
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 mainly 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.
Study objective
The purpose of this study is to assess the outcomes of monitoring the fetal
condition with STV in cCTG compared to visual interpretation of the CTG in
order to time delivery in pregnant women with severe, early-onset FGR.
Study design
Stepped wedge cluster-randomized trial.
Intervention
-Visual interpretation of cardiotocography.
-Short term variation analysis in computerized cardiotocography.
Study burden and risks
Based on the scarce evidence on cCTG with STV, we expect a decrease of 11% in
the primary outcome. Since no RCT*s are available directly comparing STV with
visual interpretation of CTG, we cannot make an estimation on whether there
will be a significant difference in gestational age at delivery and length of
NICU stay. However, based on the hypothesis that the STV reflects early signs
of hypoxia, we hypothesize that the gestational age at delivery and birthweight
will be slightly lower in the intervention group. We hypothesize that the
advantage of the lack of hypoxia outweigh the disadvantage of (probably one to
several day(s)) potential lower gestational age at delivery and birthweight,
however no literature is available to directly answer this question. A
retrospective analysis of liveborn FGR infants born below 30 weeks of
gestation, delivered before CTG abnormalities occurred, compared with
appropriate grown infants born < 30 weeks, showed similar short- and long-term
outcomes. Also, the TRUFFLE study did not show significant differences in
short- and long-term outcomes, when comparing STV with early or late ductus
venosus changes; however, in this study no significant differences in
gestational age at delivery and birthweight appeared. No specific risks related
to the study are anticipated for the mother, since only the decision on the
moment of delivery will be influenced by the intervention.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Inclusion criteria
- 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 as
biometric ultrasound measurement of the abdominal circumference OR a
combination of measurements resulting in an estimated fetal weight below the
10th percentile AND umbilical artery Doppler pulsatility index >p95. - Maternal
age >= 16 years. - written informed consent
Exclusion criteria
- Known congenital or chromosomal anomalies influencing perinatal outcome. -
Imminent labour or expected maternal indication for delivery < 48 hours.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84591.000.24 |