Clinical Trials Logo

Clinical Trial Summary

Fetal growth restriction is one of the major causes of perinatal morbidity, mortality and adverse neurological outcome. Growth restricted fetuses do not reach their potential due to multiple factors. Although early (<32 weeks' gestation) FGR is associated with the highest risk of adverse outcomes, late FGR (≤ 32 weeks' gestation) is more common in daily maternal-fetal medicine care. Despite its' prevalence, optimal standard for monitoring differs between the centers and may be difficult in case of limited access to advanced perinatal care. We present a protocol for COmputerized CTG Self-MOnitoring versus Standard Doppler assessment in Late-onset FGR (COSMOS) trial, which is a prospective, cross-over, open-label and randomized trial that compares two different protocols for late-onset FGR observation. All women carrying fetuses with late-onset FGR with positive end-diastolic flow in umbilical artery will be invited to participate in the randomized trial. Patients will be randomly divided into two groups: CTG - a group that will receive electronic device for cCTG home assessment, and Doppler - a group that will be monitored according to standard Doppler velocimetry criteria. Further management will depend on the arm of the study. Pregnancy and neonatal outcomes will be collected and analyzed.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05034861
Study type Interventional
Source Institute of Mother and Child, Warsaw, Poland
Contact Urszula Nowacka, MD
Phone +48223277044
Email [email protected]; [email protected]
Status Not yet recruiting
Phase N/A
Start date November 2021
Completion date December 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03662178 - Investigating the Structured Use of Ultrasound Scanning for Fetal Growth
Recruiting NCT03067298 - Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening N/A
Recruiting NCT01981824 - Prediction of Growth Restricted Fetuses Using Femur Length to Mid-thigh Circumference Ratio: A Case-control Study N/A
Recruiting NCT04215107 - Fetal Distribution of Feto-placental Blood Flow Related to Placental Nutrient Transport and Maternal Food Intake N/A
Completed NCT02189148 - First-trimester Prediction of Preeclampsia
Recruiting NCT04084990 - Sleep Apnea and Fetal Growth Restriction Phase 3
Recruiting NCT04051567 - Low-dose Aspirin for Prevention of Adverse Pregnancy Outcomes in Twin Pregnancies Phase 4
Recruiting NCT04394611 - Metals and in Fetal Growth Restriction
Completed NCT01369940 - The NICHD Fetal Growth Study: Twin Gestations N/A
Not yet recruiting NCT03121196 - Social Deprivation and Pregnancy N/A
Recruiting NCT03177824 - Sildenafil Citrate for Treatment of Growth-restricted Fetuses Phase 3
Completed NCT02379832 - Pre-Eclampsia And Growth Restriction: a Longitudinal Study
Completed NCT02379494 - First Trimester Prediction of Preeclampsia and Fetal Growth Restriction N/A
Completed NCT03046355 - Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women N/A
Recruiting NCT04438668 - Evaluation of the Safety and Performance of Centaflow N/A
Not yet recruiting NCT01538134 - Antiphospholipid Antibodies and Fetal Growth Restriction N/A
Withdrawn NCT04557475 - Transplacental Aspirin Therapy for Early Onset Fetal Growth Restriction Phase 3
Recruiting NCT03230162 - Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment Phase 3
Completed NCT01068795 - Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome N/A
Terminated NCT02277132 - The Dutch STRIDER (Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction) Phase 2/Phase 3