SCRIPT: Sickle Cell Risk in Pregnancy Tool

NCT06529042 | Enrolling By Invitation

• 1 other identifier: SCRIPT
• Study Type: observational
• Target: 1,000
• Locations: 2 countries
• Sites: 3

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.

Conditions

Sickle Cell Disease; Pregnancy, High Risk; Pregnancy Complications

Keywords

Risk Assessment; Bayesian Prediction

Outcome Measures

Primary Outcomes (1)

• Presence of Adverse Pregnancy Outcome

  Yes, if any of the following events first noted during the pregnancy within the study period: acute anemia (yes, no), cardiac complication (yes, no), pulmonary complication (yes, no), hepatobiliary complication (yes, no), MSK complication (yes, no), splenic complication (yes, no), neurologic complication (yes, no), renal complication (yes, no); multi-organ failure (yes, no), venous thromboembolism (yes, no), vaso-occlusive event with admission (yes, no), red cell transfusion (yes, no), maternal mortality (yes, no), hypertensive disorder of pregnancy (yes, no), preterm birth (yes, no), small for gestational age (yes, no), or perinatal mortality (yes, no); defined based on published classifications.

  During pregnancy (until delivery of infant, up to 42 weeks of gestation)

Secondary Outcomes (16)

• Presence of Acute Anemia

  During pregnancy (until delivery of infant, up to 42 weeks of gestation)

• Presence of Cardiac Complications

  During pregnancy (until delivery of infant, up to 42 weeks of gestation)

• Presence of Pulmonary Complications

  During pregnancy (until delivery of infant, up to 42 weeks of gestation)

• Presence of Hepato-Biliary Complications

  During pregnancy (until delivery of infant, up to 42 weeks of gestation)

• Presence of Musculo-Skeletal Complications

  During pregnancy (until delivery of infant, up to 42 weeks of gestation)

Study Arms (1)

Pregnancies of Individuals with Sickle Cell Disease

Other: Non-Interventional

Interventions

Non-Interventional OTHER

Non-Interventional

Pregnancies of Individuals with Sickle Cell Disease

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant Individuals with Sickle Cell Disease (HbSS, HbSC, HbS/β0-thalassemia, HbS/β+-thalassemia)

You may qualify if:

• 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)

You may not qualify if:

• Inability to confirm SCD genotype
• Incomplete medical records.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Johns Hopkins University: collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator
• St. Paul's Hospital, Vancouver (Providence Health Care): collaborator

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Providence Health Care

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

Location

Related Publications (20)

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• Silva FAC, Ferreira ALCG, Hazin-Costa MF, Dias MLG, Araujo AS, Souza AI. Adverse clinical and obstetric outcomes among pregnant women with different sickle cell disease genotypes. Int J Gynaecol Obstet. 2018 Oct;143(1):89-93. doi: 10.1002/ijgo.12626. Epub 2018 Aug 6.

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• Malinowski AK, Kuo KHM, Tomlinson GA, Palcu P, Ward R, Shehata N. Distinct maternal and fetal pregnancy outcomes in women with sickle cell disease can be predicted using routine clinical and laboratory data. Br J Haematol. 2021 Sep;194(6):1063-1073. doi: 10.1111/bjh.17607. Epub 2021 Jun 14.

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MeSH Terms

Conditions

Anemia, Sickle Cell; Pregnancy Complications

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• A. Kinga Malinowski, MD, MSc

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 31, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (2)