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The CErebro Placental RAtio as indicator for delivery following perception of reduced fetal movements, protocol for an international cluster randomised clinical trial; the CEPRA study
Background
Routine assessment in (near) term pregnancy is often inaccurate for the identification of fetuses who are mild to moderately compromised due to placental insufficiency and are at risk of adverse outcomes, especially when fetal size is seemingly within normal range for gestational age. Although biometric measurements and cardiotocography are frequently used, it is known that these techniques have low sensitivity and specificity. In clinical practice this diagnostic uncertainty results in considerable ‘over treatment’ of women with healthy fetuses whilst truly compromised fetuses remain unidentified. The CPR is the ratio of the umbilical artery pulsatility index over the middle cerebral artery pulsatility index. A low CPR reflects fetal redistribution and is thought to be indicative of placental insufficiency independent of actual fetal size, and a marker of adverse outcomes. Its utility as an indicator for delivery in women with reduced fetal movements (RFM) is unknown. The aim of this study is to assess whether expedited delivery of women with RFM identified as high risk on the basis of a low CPR improves neonatal outcomes. Secondary aims include childhood outcomes, maternal obstetric outcomes, and the predictive value of biomarkers for adverse outcomes.
Methods
International multicentre cluster randomised trial of women with singleton pregnancies with RFM at term, randomised to either an open or concealed arm. Only women with an estimated fetal weight ≥ 10th centile, a fetus in cephalic presentation and normal cardiotocograph are eligible and after informed consent the CPR will be measured. Expedited delivery is recommended in women with a low CPR in the open arm. Women in the concealed arm will not have their CPR results revealed and will receive routine clinical care. The intended sample size based on the primary outcome is 2160 patients. The primary outcome is a composite of: stillbirth, neonatal mortality, Apgar score < 7 at 5 min, cord pH < 7.10, emergency delivery for fetal distress, and severe neonatal morbidity.
Discussion
The CEPRA trial will identify whether the CPR is a good indicator for delivery in women with perceived reduced fetal movements.
Trial registration
Dutch trial registry (NTR), trial
NL7557
. Registered 25 February 2019.
Journal Article
Three minus one : parents' stories of love & loss
The loss of a child is unlike any other, and the impact that it has on the mother, the father, their family, and their friends is devastating--a shockwave of pain and guilt that spreads through their entire community. But the majority of those affected, especially mothers, often suffer their pain in silence, convinced that their grief and trauma is theirs to bear alone. This anthology of raw memoirs, heartbreaking stories, truthful poems, beautiful painting, and stunning photography from the parents who have suffered child loss offers insight into this unique, devastating and life-changing experience--breaking the silence and offering a ray of hope to the many parents out there in search of answers, understanding, and healing.
Book
A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection
Congenital cytomegalovirus infection is a cause of serious perinatal complications. In this randomized trial involving 399 pregnant women, CMV hyperimmune globulin was found to provide no benefit with respect to congenital CMV infection or perinatal death.
Journal Article
Randomized Trial of Fetal Surgery for Severe Left Diaphragmatic Hernia
In this trial involving fetuses with severe left congenital diaphragmatic hernia, fetoscopic endoluminal tracheal occlusion at 27 to 29 weeks of gestation significantly increased survival to discharge, but it resulted in an increased incidence of preterm, prelabor rupture of membranes and preterm birth.
Journal Article
A Randomized Trial of Prenatal versus Postnatal Repair of Myelomeningocele
In this trial comparing prenatal repair of myelomeningocele with standard postnatal repair, the prenatal-surgery group had better outcomes and better mental and motor function at the age of 30 months. However, these benefits came with some increased risks.
Spina bifida is the most common of congenital anomalies of the central nervous system that are compatible with life. The most frequent form is myelomeningocele, characterized by the extrusion of the spinal cord into a sac filled with cerebrospinal fluid, resulting in lifelong disability. Despite folic acid fortification, the incidence of myelomeningocele has stabilized at 3.4 per 10,000 live births in the United States.
1
Liveborn infants with myelomeningocele have a death rate of approximately 10%.
2
–
4
Long-term survivors have major disabilities, including paralysis and bowel and bladder dysfunction. Damage to the spinal cord and peripheral nerves usually is evident at . . .
Journal Article
Angiogenic factors versus fetomaternal Doppler for fetal growth restriction at term: an open-label, randomized controlled trial
Small fetuses, with estimated fetal weight (EFW) below the tenth percentile, are classified as fetal growth restriction (FGR) or small for gestational age (SGA) based on prenatal ultrasound. FGR fetuses have a greater risk of stillbirth and perinatal complications and may benefit from serial ultrasound scans to guide early delivery. Abnormal serum angiogenic factors, such as the soluble fms-like tyrosine kinase-1 (sFlt-1):placental growth factor (PlGF) ratio, have shown potential to more accurately distinguish FGR from SGA, with fewer false positives. This randomized controlled trial compared a management protocol based on the sFlt-1:PlGF with EFW and Doppler ultrasound in avoiding adverse perinatal outcomes in small fetuses after 36 weeks of gestation. A total of 1,088 pregnant women with singleton pregnancies were randomized to either the Doppler-based (control) or the sFlt-1:PlGF-based (intervention) protocol. The primary outcome, neonatal acidosis or Cesarean delivery as a result of abnormal cardiotocography, was assessed in 1,013 participants. The incidence was 10.5% in the intervention group and 10.0% in the control group (absolute difference, 0.53 (−3.21 to 4.26)), with the upper limit of the confidence interval <8.5%, confirming noninferiority. Thus, the sFlt-1:PlGF was noninferior to EFW and Doppler ultrasound in avoiding neonatal acidosis or Cesarean delivery owing to nonreassuring fetal status in small fetuses after 36 weeks (ClinicalTrials.gov registration:
NCT04502823
).
In 1,088 pregnant individuals, assessment of abnormal serum angiogenic factors is demonstrated to be noninferior to the standard clinical approach based on estimated fetal weight and Doppler percentiles for the identification of fetuses at a higher risk of neonatal acidosis or Cesarean delivery, thus offering a beneficial option in settings where Doppler or experienced sonographers are not readily available.
Journal Article
Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia
In this randomized trial involving fetuses with moderate left congenital diaphragmatic hernia, fetoscopic endoluminal tracheal occlusion at 30 to 32 weeks of gestation did not significantly increase survival to discharge from a NICU or reduce the need for oxygen supplementation at 6 months, and it increased the risks of preterm, prelabor rupture of membranes and preterm birth. The surgical technique is shown in an animated video.
Journal Article
Maternal and fetal genetic effects on birth weight and their relevance to cardio-metabolic risk factors
Birth weight variation is influenced by fetal and maternal genetic and non-genetic factors, and has been reproducibly associated with future cardio-metabolic health outcomes. In expanded genome-wide association analyses of own birth weight (
n
= 321,223) and offspring birth weight (
n
= 230,069 mothers), we identified 190 independent association signals (129 of which are novel). We used structural equation modeling to decompose the contributions of direct fetal and indirect maternal genetic effects, then applied Mendelian randomization to illuminate causal pathways. For example, both indirect maternal and direct fetal genetic effects drive the observational relationship between lower birth weight and higher later blood pressure: maternal blood pressure-raising alleles reduce offspring birth weight, but only direct fetal effects of these alleles, once inherited, increase later offspring blood pressure. Using maternal birth weight-lowering genotypes to proxy for an adverse intrauterine environment provided no evidence that it causally raises offspring blood pressure, indicating that the inverse birth weight–blood pressure association is attributable to genetic effects, and not to intrauterine programming.
An expanded GWAS of birth weight and subsequent analysis using structural equation modeling and Mendelian randomization decomposes maternal and fetal genetic contributions and causal links between birth weight, blood pressure and glycemic traits.
Journal Article