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Low molecular weight heparin in the treatment of early fetal growth restriction – a Randomized Controlled Trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516572-15-00
Acronym
1375_RCF_MAC
Enrollment
160
Registered
2024-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Growth Restriction

Brief summary

Gestational age at delivery

Detailed description

Evolution of fetal Doppler parameters (umbilical artery pulsatility index, middle cerebral artery pulsatility index, cerebralplacental ratio, ductus venosus pulsatility index), Evolution of maternal doppler parameters (uterine artery pulsatility index), Maternal body mass index (BMI) at moment of randomization, Newborn weight, percentile, umbilical artery pH and Apgar score in the 5th minute, Neonatal intensive care admission and duration of admission, A composite outcome of severe neonatal morbidity (evidence of one or more of: intraventricular hemorrhage grade 3 or 4; cystic periventricular leukomalacia; chronic lung disease; retinopathy of prematurity requiring treatment; necrotizing enterocolitis requiring surgery), Gestational hypertension or preeclampsia, Placental abruption, Antepartum hemorrhage, Maternal thrombocytopenia (platelets < 100 000 x 109/L), Stillbirth, Mode of delivery, Indication for delivery, Postpartum hemorrhage, Placental pathology, sFLT1-PLGF ratio, Syncytiotrophoblast derived vesicles (STD-EVS)

Interventions

DRUG4 mL solução injetável em seringa pré-cheia

Sponsors

Unidade Local De Saude De Sao Jose E.P.E.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Gestational age at delivery

Secondary

MeasureTime frame
Evolution of fetal Doppler parameters (umbilical artery pulsatility index, middle cerebral artery pulsatility index, cerebralplacental ratio, ductus venosus pulsatility index), Evolution of maternal doppler parameters (uterine artery pulsatility index), Maternal body mass index (BMI) at moment of randomization, Newborn weight, percentile, umbilical artery pH and Apgar score in the 5th minute, Neonatal intensive care admission and duration of admission, A composite outcome of severe neonatal morbidity (evidence of one or more of: intraventricular hemorrhage grade 3 or 4; cystic periventricular leukomalacia; chronic lung disease; retinopathy of prematurity requiring treatment; necrotizing enterocolitis requiring surgery), Gestational hypertension or preeclampsia, Placental abruption, Antepartum hemorrhage, Maternal thrombocytopenia (platelets < 100 000 x 109/L), Stillbirth, Mode of delivery, Indication for delivery, Postpartum hemorrhage, Placental pathology, sFLT1-PLGF ratio, Syncytiotr

Countries

Portugal

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026