scholarly journals Protect-me: a parallel-group, triple blinded, placebo-controlled randomised clinical trial protocol assessing antenatal maternal melatonin supplementation for fetal neuroprotection in early-onset fetal growth restriction

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e028243 ◽  
Author(s):  
Kirsten R Palmer ◽  
Joanne C Mockler ◽  
Miranda L Davies-Tuck ◽  
Suzanne L Miller ◽  
Stacy K Goergen ◽  
...  
Keyword(s):  
Fetal Growth ◽  
Fetal Growth Restriction ◽  
Early Onset ◽  
Perinatal Death ◽  
Controlled Trial ◽  
Brain Mri ◽  
Randomised Clinical Trial ◽  
Growth Restriction ◽  
Cognitive Domain ◽  
Singleton Pregnancy

IntroductionFetal growth restriction (FGR) is a serious pregnancy complication, associated with increased rates of perinatal death and morbidity among survivors. Most commonly FGR results from placental insufficiency, where the placenta fails to deliver the oxygen and nutrients required for normal fetal growth. This leads to fetal oxidative stress, resulting in organ damage through lipid peroxidation. The early developing brain is particularly susceptible, such that FGR is associated with poorer neurodevelopment, witnessed as cognitive and behavioural dysfunction, and cerebral palsy. Promisingly, melatonin, a lipid soluble antioxidant is neuroprotective in animal models of FGR. We present a protocol outlining a randomised, placebo-controlled trial to explore whether antenatal maternal melatonin supplementation in pregnancies with severe, early-onset FGR can improve neurodevelopment among survivors at 2 years of age.Methods and analysesWe will recruit 336 women with a singleton pregnancy complicated by FGR between 23+0 and 31+6 weeks gestation. Participants will be randomised, stratified by gestational age, to either 30 mg melatonin per day or a visually identical placebo, continued until birth. Measures of maternal and fetal health will be collected until birth. Timing of birth will be determined by the treating clinical team in discussion with the woman. Neonatal and infant neurodevelopmental assessments will be undertaken, consisting of brain MRI at term corrected age, general movements assessment at term and 3 months’ corrected age, and Bayley Scales of Infant & Toddler Development-III and Infant Toddler Social Emotional Assessment at 2.5 years corrected age. Analyses will be on intention to treat. The primary outcome is a difference of 5 points in the cognitive domain of the Bayley-III. Secondary outcomes address maternal and fetal safety.Ethics and disseminationThis trial has Monash Health Human Research and Ethics committee approval (17-0000-583A). Findings will be disseminated through peer-reviewed publications, conference presentations and to participants.Trial registration numberACTRN12617001515381; Pre-results

scholarly journals Longitudinal change of sFlt-1/PlGF ratio in singleton pregnancy with early-onset fetal growth restriction

2018 ◽  
Vol 52 (5) ◽  
pp. 631-638 ◽  
Author(s):  
I. Herraiz ◽  
M. S. Quezada ◽  
J. Rodriguez-Calvo ◽  
E. Gómez-Montes ◽  
C. Villalaín ◽  
...  
Keyword(s):  
Fetal Growth ◽  
Fetal Growth Restriction ◽  
Early Onset ◽  
Growth Restriction ◽  
Longitudinal Change ◽  
Singleton Pregnancy ◽  
Plgf Ratio

scholarly journals The role of sildenafil citrate in the treatment of fetal growth restriction: a randomized controlled trial

2019 ◽  
Vol 8 (5) ◽  
pp. 1840
Author(s):  
Ahmed Abdelshafy ◽  
Khaled Ibrahim Abdullah ◽  
Sherif Ashoush ◽  
Heba E. Hosni
Keyword(s):  
Middle Cerebral Artery ◽  
Fetal Growth ◽  
Cerebral Artery ◽  
Fetal Growth Restriction ◽  
Umbilical Artery ◽  
Controlled Trial ◽  
Maternity Hospital ◽  
Growth Restriction ◽  
Sildenafil Citrate ◽  
Doppler Velocity

Background: This study was aimed to evaluate the effect of sildenafil citrate on Doppler velocity indices in patients with fetal growth restriction (FGR) associated with impaired placental circulation.Methods: A double-blinded, parallel group randomized clinical trial (clinicaltrials.gov NCT02590536) was conducted in Ain Shams Maternity Hospital, in the period between October 2015 and June 2017. Ninety pregnant women with documented intrauterine growth retardation at 24-37 weeks of gestation were randomized to either sildenafil citrate 25 mg orally every 8 hours or placebo visually-identical placebo tablets with the same regimen. The primary outcome of the study was the change in umbilical artery and fetal middle cerebral artery indices.Results: There was a significant improvement in umbilical and middle cerebral artery indices after sildenafil administration p<0.001. Present study observed that, sildenafil group, in comparison to placebo, has a significantly higher mean neonatal birth weight. 1783±241g vs 1570±455g (p<0.001). There was a significantly higher mean gestational age at delivery in women in sildenafil group 35.3±1.67 weeks, whereas it was lower in the placebo group 33.5±1.7 weeks. The side effects as headache, palpitation and facial flushing were significantly higher in sildenafil group compared to placebo group.Conclusions: The use sildenafil citrate in pregnancies with fetal growth restriction (FGR) improved the feto-placental Doppler indices (pulsatility index of umbilical artery and middle cerebral artery) and improved neonatal outcomes.

641 Fetal growth restriction and risk of intrapartum cesarean among women with early onset preeclampsia

2021 ◽  
Vol 224 (2) ◽  
pp. S403
Author(s):  
Emily N. Flagler ◽  
Erin M. Cleary ◽  
Michelle R. Petrich ◽  
Emily A. Armstrong ◽  
Patricia K. Belle ◽  
...  
Keyword(s):  
Fetal Growth ◽  
Fetal Growth Restriction ◽  
Early Onset ◽  
Growth Restriction ◽  
Early Onset Preeclampsia

scholarly journals Risk stratification for early-onset fetal growth restriction in women with abnormal serum biomarkers: a retrospective cohort study

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
L. Ormesher ◽  
L. Warrander ◽  
Y. Liu ◽  
S. Thomas ◽  
L. Simcox ◽  
...  
Keyword(s):  
Fetal Growth ◽  
Fetal Growth Restriction ◽  
Early Onset ◽  
Late Onset ◽  
Area Under The Curve ◽  
Maternal Serum ◽  
Serum Biomarkers ◽  
Growth Restriction ◽  
Aneuploidy Screening ◽  
Internal Validation

AbstractAbnormal maternal serum biomarkers (AMSB), identified through the aneuploidy screening programme, are frequent incidental findings in pregnancy. They are associated with fetal growth restriction (FGR), but previous studies have not examined whether this association is with early-onset (< 34 weeks) or late-onset (> 34 weeks) FGR; as a result there is no consensus on management. The aims of this study were to determine the prevalence and phenotype of FGR in women with AMSB and test the predictive value of placental sonographic screening to predict early-onset FGR. 1196 pregnant women with AMSB underwent a 21–24 week “placental screen” comprising fetal and placental size, and uterine artery Doppler. Multivariable regression was used to calculate a predictive model for early-onset FGR (birthweight centile < 3rd/< 10th with absent umbilical end-diastolic flow, < 34 weeks). FGR prevalence was high (10.3%), however early-onset FGR was uncommon (2.3%). Placental screening effectively identified early-onset (area under the curve (AUC) 0.93, 95% confidence interval (CI) 0.87–1.00), but not late-onset FGR (AUC 0.70, 95% CI 0.64–0.75). Internal validation demonstrated robust performance for detection/exclusion of early-onset FGR. In this cohort, utilisation of our proposed algorithm with targeted fetal growth and Doppler surveillance, compared with universal comprehensive surveillance would have avoided 1044 scans, potentiating significant cost-saving for maternity services.

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