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

Sponsor

Institute of Mother and Child, Warsaw, Poland (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05034861

Collaborator

Bielanski Hospital (Other)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fetal Growth Restriction	Device: cCTG Diagnostic Test: Doppler	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: cCTG cCTG group, that will undergo a following process: EFW and Doppler assessment biweekly, and instead of additional weekly Doppler-only assessment, the patients will be provided with an electronic cCTG device at no cost (Carebits). Women will be asked to apply Carebits device at least twice weekly for at least 30 minutes (e.g. Mondays-Thursdays) with minimum 72 hours interval in case of 2 sessions per week. The trace will be examined by an independent centre, available 24 hours daily. The person examining the trace is trained or already specialized in Obs&Gynae. In case of situation requiring medical intervention, the patient will be immediately contacted by phone and advised to self-refer to the nearest Antenatal Unit. In case of normal trace, a full report will follow within 30 minutes after last reading of the trace.	Device: cCTG Self-applied home computerized CTG device used twice weekly instead of standard Doppler assessment once weekly. Other Names: Carebits device www.carebits.pl
Active Comparator: Doppler Doppler group, that will undergo a standard process of antenatal care in case of FGR. The EFW will be assessed biweekly. In case of positive end-diastolic flow in UA, Doppler assessment (MCA PI, UA PI, DV PI, Ut PI) will be provided on a weekly basis. In case of deterioration to AEDF/REDF, further management will depend on clinical situation and the patient will be excluded from the study group (applies to both arms).	Diagnostic Test: Doppler Standard Doppler assessment provided once weekly in case of late FGR with positive end diastolic flow in the umbilical artery. Other Names: Doppler assessment

Arm

Intervention/Treatment

Experimental: cCTG

cCTG group, that will undergo a following process: EFW and Doppler assessment biweekly, and instead of additional weekly Doppler-only assessment, the patients will be provided with an electronic cCTG device at no cost (Carebits). Women will be asked to apply Carebits device at least twice weekly for at least 30 minutes (e.g. Mondays-Thursdays) with minimum 72 hours interval in case of 2 sessions per week. The trace will be examined by an independent centre, available 24 hours daily. The person examining the trace is trained or already specialized in Obs&Gynae. In case of situation requiring medical intervention, the patient will be immediately contacted by phone and advised to self-refer to the nearest Antenatal Unit. In case of normal trace, a full report will follow within 30 minutes after last reading of the trace.

Device: cCTG

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

Other Names:

Carebits device

www.carebits.pl

Active Comparator: Doppler

Doppler group, that will undergo a standard process of antenatal care in case of FGR. The EFW will be assessed biweekly. In case of positive end-diastolic flow in UA, Doppler assessment (MCA PI, UA PI, DV PI, Ut PI) will be provided on a weekly basis. In case of deterioration to AEDF/REDF, further management will depend on clinical situation and the patient will be excluded from the study group (applies to both arms).

Diagnostic Test: Doppler

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

Other Names:

Doppler assessment

Outcome Measures

Primary Outcome Measures

Condition at birth [5 minutes after delivery]
Incidence of Apgar score at 5 min <7 or arterial pH of <7.0 or venous <7.1 or resuscitation (compressions, medications, intubation)
Neonatal Intensive Care Unit admission [anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier]
Incidence any admission to the Neonatal Intensive Care Unit
Brain injury [anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier]
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
Ventilation [anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier]
defined as need of positive pressure (continuous positive airway pressure (CPAP or nasal CPAP) or intubation rate
Respiratory distress syndrome [anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier]
defined as need of surfactant and ventilation as a result of prematurity
Cardiovascular support/treatment [anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier]
Incidence of anaemia-defined as low haemoglobin and/or haematocrit requiring blood transfusion or DIC - disseminated coagulopathy or ductus arteriosus treatment or hypotensive treatment
Neonatal sepsis [anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier]
Incidence of confirmed bacteraemia in cultures or necrotizing enterocolitis - Necrotising enterocolitis (NEC)
Retinopathy [anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier]
incidence of retinopathy requiring laser or anti-VEGF administration
Fetal/neonatal death [anytime after the recruitment visit or after delivery before discharge from the hospital or up to 4 weeks after delivery if discharged earlier]
Rate of death in utero or after delivery before discharge from the hospital or up to 4 weeks after delivery if discharged earlier

Secondary Outcome Measures

Maternal anxiety levels [at the recruitment visit and every 2 weeks until delivery]
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).
Compliance [after the recruitment visit until delivery]
adherence to the plan of care - % of the patients attending scheduled visits
Number of hospital visits [after the recruitment visit until delivery]
total number of meetings with the healthcare provider
Mode of delivery [through study completion, an average of 5 weeks after the recruitment visit]
rate of vaginal/caesarean; spontaneous/planned/emergency
Onset of labour [through study completion, an average of 5 weeks after the recruitment visit]
rate of spontaneous/induced/caesarean before uterine contractions
Gestational hypertension [between 20 weeks' gestation - up to 6 weeks after birth]
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)
Preeclampsia [between 20 weeks' gestation - up to 6 weeks after birth]
incidence of preeclampsia defined by International Society for Study of Hypertension in Pregnancy (ISSHP) (maternal factors)