COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: COSMOS Study

Launched by INSTITUTE OF MOTHER AND CHILD, WARSAW, POLAND · Aug 31, 2021

Keywords

ClinConnect Summary

The COSMOS Study is a clinical trial aimed at finding the best way to monitor pregnancies affected by late-onset fetal growth restriction (FGR). FGR happens when a fetus doesn't grow as much as it should, which can lead to serious health issues for the baby. In this study, women who are between 32 and 36 weeks pregnant with a single baby that shows signs of late-onset FGR will be invited to participate. Eligible participants must be at least 18 years old and speak either Polish or English. They will be randomly assigned to one of two groups: one group will use a special electronic device at home to monitor their baby's heart rate, while the other group will have standard check-ups using a Doppler ultrasound.

Participants can expect to be monitored closely throughout their pregnancy, and the study will collect information on both pregnancy and baby outcomes. This trial is currently recruiting, so if you meet the eligibility criteria and are interested, it could be a great opportunity to contribute to research aimed at improving care for pregnancies affected by growth issues.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • women aged 18 years or older,
• • singleton pregnancy,
• • ≥32+0 and ≤36+6 weeks' of gestation,
• • fluent in Polish or English,
• • diagnosed with late-onset FGR based of the Delphi criteria,
• • with positive EDF in UA,
• • with macroscopically normal fetus on ultrasound assessment.
• Exclusion Criteria:
• • multiple pregnancy,
• • fetal malformations,
• • abnormal genetic testing results (if available),
• • uncertain pregnancy dating,
• • indication for immediate delivery within 48 hours after enrollment,
• • preterm prelabour rupture of membranes.