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Updated: Jul 23, 2025

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
Published on: January 12, 2018
PREPARE: A Stepped-Wedge Cluster-Randomized Trial to Evaluate Whether Risk Stratification Can Reduce Preterm
Leandro De Oliveira1, James M Roberts2, Arundhathi Jeyabalan2
1Botucatu Medical School, Obstetrics Department, Botucatu Sao Paulo State University, SP, Brazil (L.D.O.).
Implementing a risk stratification model for preterm preeclampsia did not reduce early deliveries. Further research is needed to improve prediction of disease severity and safely manage pregnancies.
Area of Science:
- Maternal-fetal medicine
- Clinical obstetrics
- Perinatal research
Background:
- Preeclampsia poses risks to both mother and baby, with early delivery a key management decision.
- Premature birth due to early delivery in preeclampsia carries significant risks for neonates.
- This study investigated a novel risk stratification model to guide delivery decisions in preterm preeclampsia.
Purpose of the Study:
- To evaluate if a risk stratification model using biomarkers (sFlt-1/PlGF) and clinical factors could safely reduce preterm deliveries in preeclampsia.
- To assess the impact of the intervention on the rate of premature delivery in patients with suspected or confirmed preeclampsia.
Main Methods:
- A stepped-wedge cluster-randomized trial involving seven clusters.
- Patients with suspected or confirmed preeclampsia (20-36 weeks gestation) were included.
- The intervention group utilized sFlt-1/PlGF ratios and an integrated risk assessment to guide delivery recommendations, while the control group received usual care.
Main Results:
- The intervention group showed a higher adjusted risk ratio for preterm deliveries (1.45, P=0.029) compared to usual care.
- No statistical differences in preterm deliveries were found in post hoc analyses of risk differences.
- Abnormal sFlt-1/PlGF levels were linked to a higher identification rate of preeclampsia with severe features.
Conclusions:
- The implemented risk stratification model did not successfully reduce preterm deliveries in preeclampsia.
- Additional training and development of risk stratification tools are necessary for clinical practice adoption.
- The model's effectiveness in identifying severe preeclampsia warrants further investigation.
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