Enrolling by invitationNo phase

Predicting pregnancy complications in people with sickle cell disease

Tests a risk calculator to estimate pregnancy complications in people with sickle cell disease.

Key facts

Who runs it: Mount Sinai Hospital, Canada
Where: Baltimore, United StatesSee the siteAlso in 1 other country, 2 sites
Trial code: NCT06529042
Registry title: SCRIPT: Sickle Cell Risk in Pregnancy Tool
Status: Enrolling by invitation
People taking part: 1,000 people, planned
Started: 1 Sept 2024
Expected to end: Dec 2026
Type of study: Observational
Record updated: 27 November 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for pregnant people with sickle cell disease. It uses existing pregnancy records from several centres to test a tool that estimates the risk of pregnancy complications.

Age: Older than 16 years (the record lists 16 to 60 years).
Sex: Female.
Disease stage: Sickle cell disease with a confirmed type: HbSS, HbSC, HbS/β0-thalassemia or HbS/β+-thalassemia. The pregnancy must continue to at least 16+0 weeks.
Biomarker or test result: The sickle cell disease type must be confirmed by Hb electrophoresis, high performance liquid chromatography, capillary electrophoresis or genetic testing.

Main reasons for not taking part

Sickle cell disease type cannot be confirmed
Incomplete medical records
No records of pregnancy care and birth at a participating centre
Pregnancy with more than one baby

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

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)

Who cannot take part

Inability to confirm SCD genotype
Incomplete medical records

Check if you might fit

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?

Where in United States

Also in 1 other country, 2 sites

Johns Hopkins UniversityBaltimore, United StatesEnrolling by invitation

About the trial

What the trial wants to find out

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

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.