Predicting pregnancy complications in people with sickle cell disease
Tests a risk calculator to estimate pregnancy complications in people with sickle cell disease.
Plain-language title generated from the registry record
Registry title: SCRIPT: Sickle Cell Risk in Pregnancy Tool
Key facts
- Where
- Montreal and Vancouver, CanadaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 60 years old?
Source: NCT06529042, who can take part
Where in Canada
- Centre Hospitalier de l'Université de MontréalMontreal, CanadaNo longer taking part
- Providence Health CareVancouver, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mount Sinai Hospital, Canada
- Trial code
- NCT06529042
- Record updated
- 27 November 2024
- Original description
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.Read full original descriptionShow less
Prediction of Adverse Outcomes in Pregnancies of Individuals With Sickle Cell Disease - SCRIPT: Sickle Cell Risk in Pregnancy Tool
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.
Inclusion: Age >16 years; HbSS, HbSC, HbS/β0-thalassemia, HbS/β+-thalassemia confirmed on Hb electrophoresis, high performance liquid chromatography, capillary electrophoresis, or genetic testing; Records of pregnancy care and birth at a participating centre; Pregnancy continuing to at least 16+0 weeks' gestation (41,42).
Exclusion: Inability to confirm SCD genotype; Incomplete medical records.