Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04762992
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-07-07
First Post:
2021-02-17
Brief Title:
LMWH for Treatment of Early Fetal Growth Restriction HepaGrowth
Sponsor:
Centro Hospitalar de Lisboa Central
Organization:
Centro Hospitalar de Lisboa Central
Study Overview
Official Title:
Low Molecular Weight Heparin for the Treatment of Early Fetal Growth Restriction
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HepaGrowth
Brief Summary:
Early fetal growth restriction FGR is associated with considerable fetal and neonatal morbimortality Miller et al 2008 Nardozza et al 2017 Placental thrombosis infarcts and hypercoagulability are frequently seen in these pregnancies suggesting a role for the activation of the coagulation cascade in the genesis of FGR Patients will be randomized for low-molecular weight heparin or standard of care and the outcomes of both arms gestational age at delivery gestational and fetal morbidity will be compared
Detailed Description:
FGR is the second leading cause of perinatal mortality being associated with approximately 30 of stillbirths Nardozza et al 2017 Early FGR is associated with substantial disturbances of placental implantation and fetal hypoxia which requires fetal cardiovascular adaptation Both maternal and fetal Doppler alterations are present allowing for risk stratification and monitoring Arbeille et al 1995 Nardozza et al 2017a Although the precise etiology for FGR due to placental causes is unknown placental thrombosis infarcts and hypercoagulability are frequently seen suggesting a role for the activation of the coagulation cascade in the genesis of FGR Elder et al 1976 Bellart et al 1998 Fuke at al 1994 Currently the management of early FGR is limited to the monitoring of fetal Doppler parameters until the risks for preterm delivery outweight the benefits of ongoing monitoring Seravalli et al 2015 As such there is a special need for effective preventive and therapeutic interventions that improve the outcomes Low molecular weight heparin LMWH for its anticoagulant and anti-inflammatory properties has been suggested as a possible therapeutic agent in this setting Tyrell et al 1995 Yu et al 2004 Yu et al 2010 We will randomize the participants to two intervention arms in a one-to-one ratio using a computer generated randomization program The randomization will be stratified for gestational age at diagnosis of FGR 22 to 26 weeks and 26 to 32 weeks The experimental group will be administered enoxaparin subcutaneous injections 40 mg 4000 IU daily and the control group will be provided standard of care Both groups will start intervention immediately after the diagnosis of FGR and will continue it until 36 weeks of gestation or 12 hours before delivery whichever comes first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None