Health Condition 1: O09- Supervision of high risk pregnancy
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pregnant women with fetal gestation of 36-42 weeks or above with: Normal or low risk pregnancy OR high-risk pregnancy (hypertensive disorders (including preeclampsia (PE) pregnancy induced hypertension and essential hypertension) pre-existing or gestational diabetes mellitus (GDM) and reactive hypoglycemia (a condition with outcomes similar to GDM according to UCLH research) Small for Gestational Age (SGA) Fetal Growth Restriction (FGR) and postdates (40weeks) with suspected or evidence of infection or inflammation) 2. Singleton pregnancy 3. Participants aged 18 years or over
Exclusion criteria
Exclusion criteria: 1. Fetal malformation 2. Fetal genetic and structural abnormalities 3. Participants unable to read and respond to questionnaires in English or Hindi (India)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| validation of the NIRS sensor in the pregnant females of POG 36-42 weeks.Timepoint: validation of the NIRS sensor in the pregnant females of POG 36-42 weeks during 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate whether FetalSense can improve the current clinical understanding of fetal wellbeing and aid timely clinical decision-making to reduce adverse outcomes. 2. To compare the sensitivity and specificity of FetalSense with standard cardiotocography (CTG) in predicting adverse intrapartum outcomes. 3. To collect qualitative feedback from patients and healthcare providers regarding the usability, comfort, and acceptability of FetalSense during labour. 4. To develop and validate a machine learning/artificial intelligence model that integrates FetalSense data with CTG parameters for prediction of neonatal outcomes. 5. To explore the hallmark changes in optical variables during acute fetal compromise. Timepoint: these will be analysed during 24 months. | — |
Countries
India
Contacts
Public ContactDr K Aparna Sharma
All India Institute of Medical Sciences
Outcome results
None listed