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

Primary Purpose

Fetal Growth Restriction

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
cCTG
Doppler
Sponsored by
Institute of Mother and Child, Warsaw, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fetal Growth Restriction focused on measuring fetal growth restriction, fetal growth retardation, pregnancy, cardiotocography, ultrasound, Doppler, intrauterine growth restriction, maternal-fetal medicine, obstetrics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Mother and ChildRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cCTG

Doppler

Arm Description

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.

Doppler group, that will undergo a standard process of antenatal care in case of FGR. The EFW and CTG STV 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).

Outcomes

Primary Outcome Measures

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)
Neonatal Intensive Care Unit admission
Incidence any admission to the Neonatal Intensive Care Unit
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
Ventilation
defined as need of positive pressure (continuous positive airway pressure (CPAP or nasal CPAP) or intubation rate
Respiratory distress syndrome
defined as need of surfactant and ventilation as a result of prematurity
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
Neonatal sepsis
Incidence of confirmed bacteraemia in cultures or necrotizing enterocolitis - Necrotising enterocolitis (NEC)
Retinopathy
incidence of retinopathy requiring laser or anti-VEGF administration
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

Secondary Outcome Measures

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).
Compliance
adherence to the plan of care - % of the patients attending scheduled visits
Number of hospital visits
total number of meetings with the healthcare provider
Mode of delivery
rate of vaginal/caesarean; spontaneous/planned/emergency
Onset of labour
rate of spontaneous/induced/caesarean before uterine contractions
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)
Preeclampsia
incidence of preeclampsia defined by International Society for Study of Hypertension in Pregnancy (ISSHP) (maternal factors)

Full Information

First Posted
August 13, 2021
Last Updated
December 13, 2022
Sponsor
Institute of Mother and Child, Warsaw, Poland
Collaborators
Bielanski Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05034861
Brief Title
COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: COSMOS Study
Acronym
COSMOS
Official Title
COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: Study Protocol for a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Mother and Child, Warsaw, Poland
Collaborators
Bielanski Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Growth Restriction
Keywords
fetal growth restriction, fetal growth retardation, pregnancy, cardiotocography, ultrasound, Doppler, intrauterine growth restriction, maternal-fetal medicine, obstetrics

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cCTG
Arm Type
Experimental
Arm Description
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.
Arm Title
Doppler
Arm Type
Active Comparator
Arm Description
Doppler group, that will undergo a standard process of antenatal care in case of FGR. The EFW and CTG STV 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).
Intervention Type
Device
Intervention Name(s)
cCTG
Other Intervention Name(s)
Carebits device, www.carebits.pl
Intervention Description
Self-applied home computerized CTG device used twice weekly instead of standard Doppler assessment once weekly.
Intervention Type
Diagnostic Test
Intervention Name(s)
Doppler
Other Intervention Name(s)
Doppler assessment
Intervention Description
Standard Doppler assessment provided once weekly in case of late FGR with positive end diastolic flow in the umbilical artery.
Primary Outcome Measure Information:
Title
Condition at birth
Description
Incidence of Apgar score at 5 min <7 or arterial pH of <7.0 or venous <7.1 or resuscitation (compressions, medications, intubation)
Time Frame
5 minutes after delivery
Title
Neonatal Intensive Care Unit admission
Description
Incidence any admission to the Neonatal Intensive Care Unit
Time Frame
anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Title
Brain injury
Description
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
Time Frame
anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Title
Ventilation
Description
defined as need of positive pressure (continuous positive airway pressure (CPAP or nasal CPAP) or intubation rate
Time Frame
anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Title
Respiratory distress syndrome
Description
defined as need of surfactant and ventilation as a result of prematurity
Time Frame
anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Title
Cardiovascular support/treatment
Description
Incidence of anaemia-defined as low haemoglobin and/or haematocrit requiring blood transfusion or DIC - disseminated coagulopathy or ductus arteriosus treatment or hypotensive treatment
Time Frame
anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Title
Neonatal sepsis
Description
Incidence of confirmed bacteraemia in cultures or necrotizing enterocolitis - Necrotising enterocolitis (NEC)
Time Frame
anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Title
Retinopathy
Description
incidence of retinopathy requiring laser or anti-VEGF administration
Time Frame
anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Title
Fetal/neonatal death
Description
Rate of death in utero or after delivery before discharge from the hospital or up to 4 weeks after delivery if discharged earlier
Time Frame
anytime after the recruitment visit or after delivery before discharge from the hospital or up to 4 weeks after delivery if discharged earlier
Secondary Outcome Measure Information:
Title
Maternal anxiety levels
Description
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).
Time Frame
at the recruitment visit and every 2 weeks until delivery
Title
Compliance
Description
adherence to the plan of care - % of the patients attending scheduled visits
Time Frame
after the recruitment visit until delivery
Title
Number of hospital visits
Description
total number of meetings with the healthcare provider
Time Frame
after the recruitment visit until delivery
Title
Mode of delivery
Description
rate of vaginal/caesarean; spontaneous/planned/emergency
Time Frame
through study completion, an average of 5 weeks after the recruitment visit
Title
Onset of labour
Description
rate of spontaneous/induced/caesarean before uterine contractions
Time Frame
through study completion, an average of 5 weeks after the recruitment visit
Title
Gestational hypertension
Description
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)
Time Frame
between 20 weeks' gestation - up to 6 weeks after birth
Title
Preeclampsia
Description
incidence of preeclampsia defined by International Society for Study of Hypertension in Pregnancy (ISSHP) (maternal factors)
Time Frame
between 20 weeks' gestation - up to 6 weeks after birth

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant individuals
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Urszula Nowacka, MD
Phone
+48223277044
Email
ulasarzynska@gmail.com; urszula.nowacka@imid.med.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Tadeusz Issat, Professor
Phone
+48223277044
Email
tadeusz.issat@imid.med.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urszula Nowacka, MD
Organizational Affiliation
Institute of Mother and Child, Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Mother and Child
City
Warsaw
ZIP/Postal Code
01-211
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Fijałkowska, Professor
Phone
+48223277383
Email
anna.fijalkowska@imid.med.pl
First Name & Middle Initial & Last Name & Degree
Urszula Nowacka, MD, PhD
First Name & Middle Initial & Last Name & Degree
Karolina Krajewska, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available on reasonable request
IPD Sharing Time Frame
The deidentified participant data will become available upon publishing the protocol and results of the study. Study protocol will be available immediately following publication.
IPD Sharing Access Criteria
The data will be provided on request for anyone after methodologically sound proposal (contact details: urszula.nowacka@imid.med.pl).
Citations:
PubMed Identifier
32738107
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. Ultrasound Obstet Gynecol. 2020 Aug;56(2):298-312. doi: 10.1002/uog.22134. No abstract available.
Results Reference
result
PubMed Identifier
30950117
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.
Results Reference
result
PubMed Identifier
30883981
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.
Results Reference
result
PubMed Identifier
24839087
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.
Results Reference
result
PubMed Identifier
26909664
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.
Results Reference
result
PubMed Identifier
31520557
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.
Results Reference
result
PubMed Identifier
29606482
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.
Results Reference
result
PubMed Identifier
30878322
Citation
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.2019.03.002. Epub 2019 Mar 13.
Results Reference
result
PubMed Identifier
31990493
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/
Results Reference
result
PubMed Identifier
33166504
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.2020.11.004. Epub 2020 Nov 6.
Results Reference
result

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

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