RECENT PUBLICATIONS
CRADLE-4
Title: Planned delivery or expectant management for late preterm pre-eclampsia in low-income and middle-income countries (CRADLE-4): a multicentre, open-label, randomised controlled trial
Aim of the study:
- Wether planned delivery between 34+0 and 36+6 weeks gestation can reduce maternal mortality and morbidity without increasing perinatal complications.
Methods:
- Randomised controlled trial comparing planned delivery (study group) versus expectant management in women with pre-eclampsia. Participants recruited from 9 hospitals in India and Zambia and randomly allocated one of above groups.
- Primary maternal outcome – composite of maternal mortality or morbidity
- Primary perinatal outcome: composite of stillbirth, neonatal death or neonatal unit admission of more than 48H
Results:
- N=565
- Planned delivery significantly reduces severe maternal hypertension as well as a non-significant reduction in maternal morbidity and mortality.
- Planned delivery significantly reduces risk of stillbirth.
- Planned delivery showed no harmful effects to the fetus or baby.
- The median length of stay for women allocated to planned delivery was significantly lower than expectant management
Conclusion:
- It is safe to offer planned early birth to women with late preterm pre-eclampsia, without severe features, in a low or lower middle-income country setting, from 34 weeks’ gestation onwards
Title: Household air pollution and incidence of eclampsia in eight low and middle-income countries
Aim of the study:
- To evaluate whether a correlation exists between indoor air pollution (such as fuels released from cooking and heating) and eclampsia.
Methods:
- Data from CRADLE 3 trial was used
- 2692 eclamptic cases were evaluated and deaths attributable to air pollution were recorded based on the Global Burden of Disease results tool
- Countries included: Ethiopia, Haiti, India, Malawi, Sierra Leone, Uganda, Zambia, Zimbabwe
Results:
- Positive correlation between national-level data for deaths attributable to indoor household pollution and eclampsia rates
- P = 0.0019
- Indoor household pollution can therefore increase the risk of developing seizures in pre-eclampsia. The cause of this is not yet known but may be secondary to hypoxia
Conclusion
- Air pollution can impact vulnerable populations and lead to further inequalities in maternal health. Including increased morbidity from pre-eclampsia
Title: Predictive RNA profiles for early and very early spontaneous preterm birth
Aim of the study:
- To assess whether cell free RNA (cfRNA) biomarkers in the plasma is a useful molecular test for predicting spontaneous preterm birth (sPTB)
Results:
- 242 pregnant women
- 25 RNA transcripts were identified showing an association with sPTB
- cfRNA showed high predictability for sPTB in an ethnically diverse population
- cfRNA predicted sPTB in both early (<35 weeks) and very early (<25 weeks) sPTB
- Very early sPTB was associated with genes related to insulin-like growth transport and amino acid metabolism pathways
- Early sPTB was associated with genes involved in extracellular matrix degradation and remodelling
Conclusion
- Introduction of plasma screening tests can help with predicting sPTB in high risk women
- Understanding RNA profiles in maternal plasma can help better understand the mechanisms behind preterm birth
PARROT Study
Title: Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial
Aim of the study:
- To assess whether PlGF concentrations helped to decrease the time for clinicians to make a diagnosis of pre-eclampsia
- To assess whether PlGF reduced maternal and perinatal adverse outcomes
Results:
- 1023 women
- Low PlGF <100pg/Ml
- High accuracy in determining pre-eclampsia that required delivery within 14 days
- <35 weeks: sensitivity 94.9%, negative predictive value 98.3%
- 35-36+6: sensitivity 96.2%, negative predictive value 97.1%
- Time to diagnose pre-eclampsia
- Revealed testing: 1.9 days
- Concealed testing: 4.1 days
- 64% reduction in time to diagnosis p=0.027
- Severe maternal advere outcomes
- Less frequent in revealed testing group than conealed p=0.043
Conclusion
- PlGF measurements can help clinicians diagnose pre-eclampsia in a more timely manner in women presenting with suspected pre-eclampsia leading to a significant reduction in maternal adverse outcomes
PHOENIX Study
Title: Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial
Aim of the study:
- Compare planned early initiation of delivery vs. expectant management in women with pre-eclampsia between 34-37 weeks
Results:
- 901 women with late preterm pre-eclampsia
- Primary maternal outcomes were significantly lower in planned delivery group (p=0..0005)
- Primary perinatal outcomes were significantly higher in planned delivery group (p=00034)
- Planned delivery group showed increased rates of spontaneous vaginal births
Conclusion
- Lower maternal morbidity but higher neonatal unit admission (but no additional respiratory or other morbitiy), consider planned delivery in some women with late preterm preeclampsia
CRADLE 3
Title: Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial
Aim of the study:
- Whether implementation of the CRADLE VSA device alongside an education package into the community and maternity facilities in low resource settings can reduce all cause maternal mortality and morbidity.
Results:
- 8% reduction in primary outcome (maternal death, eclampsia, hysterectomy) after intervention. P=0.0056 but not significant after adjusting for event trends in each cluster.
- Significant reduction in rate of emergency hysterectomy post intervention = 0.0072
Conclusion
- The intervention was associated with a reduction in a composite of death, eclampsia, and hysterectomy but only hysterectomy was directly attributed to the intervention. The trial had insufficient power because of unexpected variation between clusters and despite the high number of primary outcome events.