AI-Powered CURAᵀᴹ Application for Identifying At-Risk Pregnancies in Obstetric Management

Condition(s) studied

Investigational drug(s) / intervention(s)

AI-risk Stratification: With the results being disclosed as 'high-risk' or 'low-risk' in the experimental arm, clinicians have to adhere to a specific 'high-risk' and 'low-risk' management protocol for participants.

Study summary

It is important to identify high pregnancies early through screening so that appropriate care and intervention may be instituted. An AI-assisted risk categorisation approach may be advantageous compared with traditional means of screening. The purpose of this study is to determine if the adoption of an AI-assisted approach in general pregnancy risk screening will improve the accuracy of antenatal risk categorization into high- and low- risk pregnancy groups, ultimately resulting in fewer poor maternal and fetal/neonatal outcomes.

Eligibility

Primary outcome measure(s)

• The number and proportion of cases displaying any one of the following outcomes listed below (composite): — At Delivery (Birth)
  Presented as a relative risk (RR) with 95% CI, with and without stratification for parity, ethnicity and BMI. (i) Maternal * Postpartum haemorrhage more than/equal to 1000ml or requiring blood product transfusion * Eclampsia/severe eclampsia (blood pressure SBP\>160mmHg or diastolic \>110mmHg and/or significant end-organ damage which can include signs of liver or kidney impairment, low platelet count, fluid in the lungs or new-onset headache/visual disturbances) * ICU or HDU admission (excluding those who are admitted for precautionary monitoring) * Unplanned hysterectomy * Uterine rupture (symptomatic full thickness rupture) * Venous thromboembolism proven radiologically * Maternal mortality (ii) Neonatal: * Apgar scores \<7 at 5 minutes or less than/equal to 4 at 10 minutes * Respiratory distress requiring mechanical ventilation or surfactant treatment * Hypoxic ischaemic encephalopathy (HIE, any grade) * neonatal death (within 28 days of birth)/ * intrauterine demise
• In addition, these outcomes will be reported individually: — At Delivery (Birth)
  Number and proportion, RR and 95% CI for each of the following: * Postpartum haemorrhage more than/equal to 1000ml or requiring blood product transfusion as well as mean difference in blood loss * Eclampsia/severe eclampsia (blood pressure SBP\>160mmHg or diastolic \>110mmHg and/or significant end-organ damage which can include signs of liver or kidney impairment, low platelet count, fluid in the lungs or new-onset headache/visual disturbances) as well as difference in gestational age of onset or diagnosis with and without adjustment for important covariates * ICU or HDU admission (excluding those who are admitted for precautionary monitoring) * Maternal mortality as well as cause of death * Respiratory distress requiring mechanical ventilation or surfactant treatment as well as aetiology for RDS * Hypoxic ischaemic encephalopathy (HIE, any grade) * Neonatal death (within 28 days of birth) * Intrauterine demise

Trial sites (1)

More National University Hospital, Singapore trials in Singapore

Other trials for the same condition