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

Fetal Growth Restriction Clinical Trial

— COSMOS  

Official title:

COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: Study Protocol for a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05034861
• Other study ID #: InstituteMCPoland
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2022
• Source: Institute of Mother and Child, Warsaw, Poland
• Contact: Urszula Nowacka, MD
• Phone: +48223277044
• Email: ulasarzynska[@]gmail.com; urszula.nowacka[@]imid.med.pl
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Growth Restriction
• Fetal Growth Retardation

Intervention

Device:
• cCTG
Self-applied home computerized CTG device used twice weekly instead of standard Doppler assessment once weekly.

Diagnostic Test:
• Doppler
Standard Doppler assessment provided once weekly in case of late FGR with positive end diastolic flow in the umbilical artery.

Locations

Country	Name	City	State
Poland	Institute of Mother and Child	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Mother and Child, Warsaw, Poland	Bielanski Hospital

Country where clinical trial is conducted

Poland, 

References & Publications (10)

Akolekar R, Ciobanu A, Zingler E, Syngelaki A, Nicolaides KH. Routine assessment of cerebroplacental ratio at 35-37 weeks' gestation in the prediction of adverse perinatal outcome. Am J Obstet Gynecol. 2019 Jul;221(1):65.e1-65.e18. doi: 10.1016/j.ajog.201 — View Citation

Antenatal and postnatal mental health: clinical management and service guidance. London: National Institute for Health and Care Excellence (NICE); 2018 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK553127/ — View Citation

Baschat AA. Planning management and delivery of the growth-restricted fetus. Best Pract Res Clin Obstet Gynaecol. 2018 May;49:53-65. doi: 10.1016/j.bpobgyn.2018.02.009. Epub 2018 Mar 1. — View Citation

Ciobanu A, Khan N, Syngelaki A, Akolekar R, Nicolaides KH. Routine ultrasound at 32 vs 36 weeks' gestation: prediction of small-for-gestational-age neonates. Ultrasound Obstet Gynecol. 2019 Jun;53(6):761-768. doi: 10.1002/uog.20258. Epub 2019 Apr 30. — View Citation

Figueras F, Gratacos E. Stage-based approach to the management of fetal growth restriction. Prenat Diagn. 2014 Jul;34(7):655-9. doi: 10.1002/pd.4412. Epub 2014 Jun 9. — View Citation

Gordijn SJ, Beune IM, Thilaganathan B, Papageorghiou A, Baschat AA, Baker PN, Silver RM, Wynia K, Ganzevoort W. Consensus definition of fetal growth restriction: a Delphi procedure. Ultrasound Obstet Gynecol. 2016 Sep;48(3):333-9. doi: 10.1002/uog.15884. — View Citation

Lai J, Syngelaki A, Nicolaides KH, von Dadelszen P, Magee LA. Impact of new definitions of preeclampsia at term on identification of adverse maternal and perinatal outcomes. Am J Obstet Gynecol. 2021 May;224(5):518.e1-518.e11. doi: 10.1016/j.ajog.2020.11. — View Citation

Lees CC, Stampalija T, Baschat A, da Silva Costa F, Ferrazzi E, Figueras F, Hecher K, Kingdom J, Poon LC, Salomon LJ, Unterscheider J. ISUOG Practice Guidelines: diagnosis and management of small-for-gestational-age fetus and fetal growth restriction. Ult — View Citation

Molina LCG, Odibo L, Zientara S, Obican SG, Rodriguez A, Stout M, Odibo AO. Validation of Delphi procedure consensus criteria for defining fetal growth restriction. Ultrasound Obstet Gynecol. 2020 Jul;56(1):61-66. doi: 10.1002/uog.20854. Epub 2020 Jun 7. — View Citation

Nohuz E, Riviere O, Coste K, Vendittelli F. Prenatal identification of small-for-gestational age and risk of neonatal morbidity and stillbirth. Ultrasound Obstet Gynecol. 2020 May;55(5):621-628. doi: 10.1002/uog.20282. Epub 2020 Apr 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Condition at birth	Incidence of Apgar score at 5 min <7 or arterial pH of <7.0 or venous <7.1 or resuscitation (compressions, medications, intubation)	5 minutes after delivery
Primary	Neonatal Intensive Care Unit admission	Incidence any admission to the Neonatal Intensive Care Unit	anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Primary	Brain injury	Incidence of Intraventricular haemorrhage (IVH) grade II or above-defined as bleeding into the ventricles; or hypoxic-ischaemic encephalopathy or periventricular leukomalacia or seizures recorded by EEG	anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Primary	Ventilation	defined as need of positive pressure (continuous positive airway pressure (CPAP or nasal CPAP) or intubation rate	anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Primary	Respiratory distress syndrome	defined as need of surfactant and ventilation as a result of prematurity	anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Primary	Cardiovascular support/treatment	Incidence of anaemia-defined as low haemoglobin and/or haematocrit requiring blood transfusion or DIC - disseminated coagulopathy or ductus arteriosus treatment or hypotensive treatment	anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Primary	Neonatal sepsis	Incidence of confirmed bacteraemia in cultures or necrotizing enterocolitis; - Necrotising enterocolitis (NEC)	anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Primary	Retinopathy	incidence of retinopathy requiring laser or anti-VEGF administration	anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Primary	Fetal/neonatal death	Rate of death in utero or after delivery before discharge from the hospital or up to 4 weeks after delivery if discharged earlier	anytime after the recruitment visit or after delivery before discharge from the hospital or up to 4 weeks after delivery if discharged earlier
Secondary	Maternal anxiety levels	measured by a screening Generalized Anxiety Disorder 7- question scale (GAD-7 scale). There are four possible answers to all the questions, corresponding to scores 0,1,2,3, respectively, therefore the total score ranges between 0 (not anxious) - 21 (severely anxious).	at the recruitment visit and every 2 weeks until delivery
Secondary	Compliance	adherence to the plan of care - % of the patients attending scheduled visits	after the recruitment visit until delivery
Secondary	Number of hospital visits	total number of meetings with the healthcare provider	after the recruitment visit until delivery
Secondary	Mode of delivery	rate of vaginal/caesarean; spontaneous/planned/emergency	through study completion, an average of 5 weeks after the recruitment visit
Secondary	Onset of labour	rate of spontaneous/induced/caesarean before uterine contractions	through study completion, an average of 5 weeks after the recruitment visit
Secondary	Gestational hypertension	incidence of new onset hypertension (blood pressure =140/90 mmHg) after 20 weeks' of gestation in the absence of preeclampsia as defined by International Society for Study of Hypertension in Pregnancy (ISSHP)	between 20 weeks' gestation - up to 6 weeks after birth
Secondary	Preeclampsia	incidence of preeclampsia defined by International Society for Study of Hypertension in Pregnancy (ISSHP) (maternal factors)	between 20 weeks' gestation - up to 6 weeks after birth