SCRIPT: Sickle Cell Risk in Pregnancy Tool

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Mount Sinai Hospital, Canada
Study ID
NCT06529042
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
FEMALE
Age
16 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Non-Interventional — OTHER
    Non-Interventional

Study Details

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.

Key Dates

Start date
Sep 1, 2024
Status verified
Jun 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Pregnancies of Individuals with Sickle Cell Disease

Primary Outcome Measure

Presence of Adverse Pregnancy Outcome [ Time Frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21218-

Find similar trials in Baltimore, MD

By condition
Sickle cell disease
By research site
Johns Hopkins University· Baltimore, MD

Related Studies