Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529042
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-06-26
Brief Title:
SCRIPT Sickle Cell Risk in Pregnancy Tool
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prediction of Adverse Outcomes in Pregnancies of Individuals With Sickle Cell Disease - SCRIPT Sickle Cell Risk in Pregnancy Tool
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCRIPT
Brief Summary:
Sickle Cell Disease SCD common in persons of Black ancestry affects the shape of hemoglobin the oxygen-carrying part of red blood cells RBC It is characterized by many complications the most dreaded of which are related to pregnancy - affecting both the mother and unborn child Compared to those without SCD people with SCD have more adverse pregnancy outcomes APO 6x maternal mortality 2x preeclampsia preterm birth 4x risk of having a baby not growing well in the womb stillbirth There is also greater need for access to care 7x higher hospitalization often multiple times lasting days to months Yet up to 30 of SCD pregnancies are uncomplicated
Treatments in pregnancy are limited and carry risks A method to distinguish pregnancies at high-risk of APO that may benefit from these potentially risky treatments from those likely to be uncomplicated is urgently needed To meet this need the investigators developed a calculator to estimate pregnancy complication risk using single-centre data Its accuracy and precision will now be evaluated with international information from several centers by testing the calculator and adjusting it as needed using already available pregnancy-data from study centres in several countries Those age 16 years who have a confirmed SCD genotype pregnancy with one baby and pregnancy care and birth at a participating study centre will be included Pregnancy care for the participants will be up to their doctors with no changes based on the study SCRIPT - the new tool - will guide future care by predicting who may benefit from specific treatments reducing harm to low-risk individuals will allow selection of high-risk patients for a future trials to determine whether currently available and novel treatments in well-selected patients can improve APO sufficiently to balance treatment-related harms
Treatments in pregnancy are limited and carry risks A method to distinguish pregnancies at high-risk of APO that may benefit from these potentially risky treatments from those likely to be uncomplicated is urgently needed To meet this need the investigators developed a calculator to estimate pregnancy complication risk using single-centre data Its accuracy and precision will now be evaluated with international information from several centers by testing the calculator and adjusting it as needed using already available pregnancy-data from study centres in several countries Those age 16 years who have a confirmed SCD genotype pregnancy with one baby and pregnancy care and birth at a participating study centre will be included Pregnancy care for the participants will be up to their doctors with no changes based on the study SCRIPT - the new tool - will guide future care by predicting who may benefit from specific treatments reducing harm to low-risk individuals will allow selection of high-risk patients for a future trials to determine whether currently available and novel treatments in well-selected patients can improve APO sufficiently to balance treatment-related harms
Detailed Description:
Sickle Cell Disease SCD is the most common haemoglobinopathy predominantly affecting persons of African descent1 In comparison to those without SCD pregnant persons with SCD have a six-fold higher risk of mortality twice the risk of preeclampsia and preterm birth and nearly a four-fold risk of having a small for gestational age infant or experiencing stillbirth23 Furthermore there is a higher rate of resource utilization in this group with nearly 50 of pregnancies complicated by at least one antenatal admission and an overall seven-fold higher hospitalization risk compared to pregnancies without SCD45 These admissions are most commonly secondary to vaso-occlusive events or anemia can occur on multiple occasions and can last days to months45
During pregnancy red blood cell RBC transfusion remains the only recommended intervention6 with some evidence suggesting that prophylactic transfusion may modify adverse pregnancy outcomes APOs78 with a possible positive effect on hospitalization rates through decreased complications though this requires further study However transfusion is not without risk Beyond its typically-feared infectious complications9 transfusion in SCD is associated with alloimmunization rates of over 3010-12 can induce life-threatening hyperhemolysis13 and will eventually lead to iron overload14 At the same time up to 30 of pregnancies in individuals with SCD remain uncomplicated231516
A tool is thus urgently needed to separate high-risk individuals who would benefit from transfusion from low-risk individuals who would accrue transfusion risks with minimal if any benefit Using a single-centre cohort the investigators developed maternal and fetal risk prediction models as the first step in permitting the selection of patients most likely to benefit from transfusion16 Ultimately a multi-center international randomized controlled trial RCT is required to determine the benefits of prophylactic transfusion in this setting yet before such an RCT is conceived the models must be refined and validated with a larger sample to allow for appropriate participant selection
The investigators proposed a multicenter international cohort study to enhance the predictive capacity and validate the current models within the participating centers The academic centers located in Canada USA and France have multi-disciplinary experts dedicated to managing pregnant persons with SCD and the combination of MFM and Haematology site co-leads provides essential interdisciplinary expertise with synergistic medical and obstetric perspectives
Once completed the Sickle Cell Risk In Pregnancy Tool SCRIPT will inform medical decisions regarding transfusion and will set the stage for appropriate selection of high-risk individuals for inclusion in an RCT aimed to definitively determine whether prophylactic transfusion in well-selected pregnant individuals with SCD does indeed improve APOs to the degree that would balance its potential associated harms
During pregnancy red blood cell RBC transfusion remains the only recommended intervention6 with some evidence suggesting that prophylactic transfusion may modify adverse pregnancy outcomes APOs78 with a possible positive effect on hospitalization rates through decreased complications though this requires further study However transfusion is not without risk Beyond its typically-feared infectious complications9 transfusion in SCD is associated with alloimmunization rates of over 3010-12 can induce life-threatening hyperhemolysis13 and will eventually lead to iron overload14 At the same time up to 30 of pregnancies in individuals with SCD remain uncomplicated231516
A tool is thus urgently needed to separate high-risk individuals who would benefit from transfusion from low-risk individuals who would accrue transfusion risks with minimal if any benefit Using a single-centre cohort the investigators developed maternal and fetal risk prediction models as the first step in permitting the selection of patients most likely to benefit from transfusion16 Ultimately a multi-center international randomized controlled trial RCT is required to determine the benefits of prophylactic transfusion in this setting yet before such an RCT is conceived the models must be refined and validated with a larger sample to allow for appropriate participant selection
The investigators proposed a multicenter international cohort study to enhance the predictive capacity and validate the current models within the participating centers The academic centers located in Canada USA and France have multi-disciplinary experts dedicated to managing pregnant persons with SCD and the combination of MFM and Haematology site co-leads provides essential interdisciplinary expertise with synergistic medical and obstetric perspectives
Once completed the Sickle Cell Risk In Pregnancy Tool SCRIPT will inform medical decisions regarding transfusion and will set the stage for appropriate selection of high-risk individuals for inclusion in an RCT aimed to definitively determine whether prophylactic transfusion in well-selected pregnant individuals with SCD does indeed improve APOs to the degree that would balance its potential associated harms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None