Fetal Growth RestrictionCOSMOSNCT05034861
COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: COSMOS Study
A study testing cCTG and Doppler in people with Fetal Growth Restriction, run by Institute of Mother and Child, Warsaw, Poland at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Growth Restriction
- What is being tested?
- cCTG and Doppler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 13 Dec 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Institute of Mother and Child
Warsaw, 01-211
Anna Fijałkowska, Professor, +48223277383, anna.fijalkowska@imid.med.pl
Urszula Nowacka, MD, PhD
About this study
Official title: COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: Study Protocol for a Randomized Controlled Trial
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.
- Conditions
- Fetal Growth Restriction
- Being tested
- cCTG, Doppler
- Keywords
- fetal growth restriction, fetal growth retardation, pregnancy, cardiotocography, ultrasound, Doppler, intrauterine growth restriction, maternal-fetal medicine, obstetrics
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cCTGDevice
Also called Carebits device, www.carebits.pl
Self-applied home computerized CTG device used twice weekly instead of standard Doppler assessment once weekly.
DopplerDiagnostic test
Also called Doppler assessment
Standard Doppler assessment provided once weekly in case of late FGR with positive end diastolic flow in the umbilical artery.
| Study group | Role | What they receive |
|---|---|---|
| cCTG | Experimental | 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. Receives: Device: cCTG |
| Doppler | Active comparator | 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). Receives: Diagnostic Test: Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 minutes after delivery
Neonatal Intensive Care Unit admission
Incidence any admission to the Neonatal Intensive Care Unit
Measured: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
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
Measured: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Ventilation
defined as need of positive pressure (continuous positive airway pressure (CPAP or nasal CPAP) or intubation rate
Measured: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Respiratory distress syndrome
defined as need of surfactant and ventilation as a result of prematurity
Measured: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
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
Measured: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Neonatal sepsis
Incidence of confirmed bacteraemia in cultures or necrotizing enterocolitis
- Necrotising enterocolitis (NEC)
Measured: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Retinopathy
incidence of retinopathy requiring laser or anti-VEGF administration
Measured: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
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
Measured: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 4 weeks after delivery if discharged earlier
Secondary outcomes (7)
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).
Measured: at the recruitment visit and every 2 weeks until delivery
Compliance
adherence to the plan of care - % of the patients attending scheduled visits
Measured: after the recruitment visit until delivery
Number of hospital visits
total number of meetings with the healthcare provider
Measured: after the recruitment visit until delivery
Mode of delivery
rate of vaginal/caesarean; spontaneous/planned/emergency
Measured: through study completion, an average of 5 weeks after the recruitment visit
Onset of labour
rate of spontaneous/induced/caesarean before uterine contractions
Measured: through study completion, an average of 5 weeks after the recruitment visit
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)
Measured: between 20 weeks' gestation - up to 6 weeks after birth
Preeclampsia
incidence of preeclampsia defined by International Society for Study of Hypertension in Pregnancy (ISSHP) (maternal factors)
Measured: between 20 weeks' gestation - up to 6 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start13 Dec 2022
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Fetal Growth RestrictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Mother and Child, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Bielanski Hospital
- Responsible party
- Principal investigator, Urszula Nowacka, Institute of Mother and Child, Warsaw, Poland
- Investigators
- Urszula Nowacka, MD, Principal investigator, Institute of Mother and Child, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034861
- Sponsor's protocol ID
- InstituteMCPoland
- Acronym
- COSMOS
- Status last verified
- Dec 2022
- First submitted
- 13 Aug 2021
- Last updated
- 15 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on reasonable request
Publications
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.
PubMed 32738107Nohuz 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.
PubMed 30950117Ciobanu 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.
PubMed 30883981Figueras 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.
PubMed 24839087Gordijn 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.
PubMed 26909664Molina 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.
PubMed 31520557Baschat 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.
PubMed 29606482Akolekar 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.
PubMed 30878322Antenatal 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/
PubMed 31990493Lai 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.
PubMed 33166504Nowacka U, Issat T, Krajewska K, Norwa A, Mazanowska N, Kowalczyk-Buss J, Kozlowski S, Kuchcinska M, Laudanski P, Jakimiuk A, Majewska A. Computerized CTG self-monitoring versus standard Doppler assessment in late-onset fetal growth restriction (cosmos): a pilot randomized controlled trial. Arch Gynecol Obstet. 2026 Jun 21. doi: 10.1007/s00404-026-08493-1. Online ahead of print.
PubMed 42323763
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05034861
- Acronym / sponsor ID
- COSMOS / InstituteMCPoland
- Conditions
- Fetal Growth Restriction
- Keywords
- fetal growth restriction, fetal growth retardation, pregnancy, cardiotocography, ultrasound, Doppler, intrauterine growth restriction, maternal-fetal medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institute of Mother and Child, Warsaw, PolandUniversity, hospital or other
- Collaborators
- Bielanski Hospital
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cCTG | Experimental | Device: cCTGcCTG 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 | Active comparator | Diagnostic Test: DopplerDoppler 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (6 listed)
- multiple pregnancy,
- fetal malformations,
- abnormal genetic testing results (if available),
- uncertain pregnancy dating,
- indication for immediate delivery within 48 hours after enrollment,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cCTGAlso: Carebits device, www.carebits.plSelf-applied home computerized CTG device used twice weekly instead of standard Doppler assessment once weekly. | Device | cCTG |
| DopplerAlso: Doppler assessmentStandard Doppler assessment provided once weekly in case of late FGR with positive end diastolic flow in the umbilical artery. | Diagnostic test | Doppler |
Primary outcome
Condition at birth
Time frame: 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
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
Incidence any admission to the Neonatal Intensive Care Unit
Brain injury
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
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
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
defined as need of positive pressure (continuous positive airway pressure (CPAP or nasal CPAP) or intubation rate
Respiratory distress syndrome
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
defined as need of surfactant and ventilation as a result of prematurity
Cardiovascular support/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
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
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
Incidence of confirmed bacteraemia in cultures or necrotizing enterocolitis - Necrotising enterocolitis (NEC)
Retinopathy
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
incidence of retinopathy requiring laser or anti-VEGF administration
Fetal/neonatal death
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
Rate of death in utero or after delivery before discharge from the hospital or up to 4 weeks after delivery if discharged earlier
7 secondary outcomes
Maternal anxiety levels
Time frame: at the recruitment visit and every 2 weeks until delivery
Compliance
Time frame: after the recruitment visit until delivery
Number of hospital visits
Time frame: after the recruitment visit until delivery
Mode of delivery
Time frame: through study completion, an average of 5 weeks after the recruitment visit
Onset of labour
Time frame: through study completion, an average of 5 weeks after the recruitment visit
Gestational hypertension
Time frame: between 20 weeks' gestation - up to 6 weeks after birth
Preeclampsia
Time frame: between 20 weeks' gestation - up to 6 weeks after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Results publication: PubMed 32738107Lees 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 publication: PubMed 30950117Nohuz 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 publication: PubMed 30883981Ciobanu 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 publication: PubMed 24839087Figueras 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 publication: PubMed 26909664Gordijn 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 publication: PubMed 31520557Molina 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 publication: PubMed 29606482Baschat 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 publication: PubMed 30878322Akolekar 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 publication: PubMed 31990493Antenatal 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 publication: PubMed 33166504Lai 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.
- Derived from this study: PubMed 42323763Nowacka U, Issat T, Krajewska K, Norwa A, Mazanowska N, Kowalczyk-Buss J, Kozlowski S, Kuchcinska M, Laudanski P, Jakimiuk A, Majewska A. Computerized CTG self-monitoring versus standard Doppler assessment in late-onset fetal growth restriction (cosmos): a pilot randomized controlled trial. Arch Gynecol Obstet. 2026 Jun 21. doi: 10.1007/s00404-026-08493-1. Online ahead of print.
- Individual participant dataSharing planned: Yes. Data will be available on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urszula Nowacka, MD principal investigator
Institute of Mother and Child, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cCTG and Doppler in people with Fetal Growth Restriction, run by Institute of Mother and Child, Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Urszula Nowacka, MD (+48223277044, ulasarzynska@gmail.com; urszula.nowacka@imid.med.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Condition at birth (time frame: 5 minutes after delivery). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05034861, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.