Sickle Cell DiseaseSCRIPTNCT06529042
SCRIPT: Sickle Cell Risk in Pregnancy Tool
An observational study of Sickle Cell Disease and Pregnancy, High Risk, run by Mount Sinai Hospital, Canada at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 years, women only
- Conditions the study is for
- Sickle Cell Disease, Pregnancy, High Risk, Pregnancy Complications
- What is being tested?
- Non-Interventional
- How many people
- 1,000 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Sep 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Pregnant Individuals with Sickle Cell Disease (HbSS, HbSC, HbS/β0-thalassemia, HbS/β+-thalassemia)
Who may be able to join
- 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 join
- Inability to confirm SCD genotype
- Incomplete medical records.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Canada2 sites
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
Providence Health Care
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: 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.
Read the detailed description
Sickle Cell Disease (SCD) is the most common haemoglobinopathy; predominantly affecting persons of African descent(1). 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 stillbirth(2,3). 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 SCD(4,5). These admissions are most commonly secondary to vaso-occlusive events or anemia, can occur on multiple occasions, and can last days to months(4,5).
During pregnancy, red blood cell (RBC) transfusion remains the only recommended intervention(6), with some evidence suggesting that prophylactic transfusion may modify adverse pregnancy outcomes (APOs)(7,8), 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 complications(9), transfusion in SCD is associated with alloimmunization rates of over 30%(10-12), can induce life-threatening hyperhemolysis(13), and will eventually lead to iron overload(14). At the same time, up to 30% of pregnancies in individuals with SCD remain uncomplicated(2,3,15,16).
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 transfusion(16). 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 model(s) 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 model(s) 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.
- Being tested
- Non-Interventional
- Keywords
- Risk Assessment, Bayesian Prediction
- Medical subject headings
- Anemia, Sickle Cell, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| Pregnancies of Individuals with Sickle Cell Disease | Not described Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Secondary outcomes (16)
Presence of Acute Anemia
Yes, if any of: hyperhemolysis [clinical diagnosis], acute splenic sequestration; hepatic sequestration, or aplastic crisis; defined based on published classification
Measured: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Cardiac Complications
Yes, if any of: congestive heart failure, cardiomyopathy, cardiomegaly, or arrhythmia; defined based on published classification
Measured: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Pulmonary Complications
Yes, if any of: acute chest syndrome; pneumonia, or pulmonary hypertension; defined based on published classification
Measured: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Hepato-Biliary Complications
Yes, if any of: cholecystitis, cholelithiasis; cholecystectomy; cholestasis of pregnancy, or viral hepatitis; defined based on published classification
Measured: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Musculo-Skeletal Complications
Yes, if any of: avascular necrosis, ulcer, myositis, or osteomyelitis; defined based on published classification
Measured: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Neurologic Complications
Yes, if any of: silent cerebral infarct, cerebrovascular accident, cerebral aneurysm, transient ischemic attack, or Moya-Moya syndrome; defined based on published classification
Measured: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Renal Complications
Yes, if any of: acute kidney injury, proteinuria, pyelonephritis, or hematuria; defined based on published classification
Measured: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Multi-Organ Failure
Consultant's opinion in chart note specifying a diagnosis of "MOF" during current study pregnancy; clinical diagnosis
Measured: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Venous Thromboembolism
Yes, if any of: deep vein thrombosis, pulmonary embolism, atypical site venous thrombosis, or cerebral venous sinus thrombosis (CVST); defined based on published classification
Measured: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Vaso-Occlusive Event with Admission
Vaso-Occlusive Event (VOE): New onset pain lasting >4 hrs in current study pregnancy, for which there is no explanation other than vaso-occlusion, and which requires presentation for acute care - patient self-report
Measured: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Provision of Red Blood Cell Transfusion
Yes, if any of: simple transfusion in pregnancy, exchange transfusion (manual exchange or erythrocytapheresis), or prophylactic transfusion
Measured: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Occurrence of Maternal Mortality
Maternal death during current study pregnancy and up to 6 months postpartum
Measured: During pregnancy (until delivery of infant, up to 42 weeks of gestation) and continuing to 6 months postpartum
Presence of Hypertensive Disorder of Pregnancy
Yes, if any of: Gestational Hypertension (gHTN) [persistent de novo HTN over 20 weeks' GA in absence of features of preeclampsia], Pre-eclampsia (PET) [gHTN + >1 new onset conditions >20 weeks GA - proteinuria or maternal organ/uteroplacental dysfunction], Eclampsia [new onset seizures in context of pre-eclampsia]; or HELLP Syndrome [Evidence of Hemolysis, Elevated Liver Enzymes, Low Platelets in context of pre-eclampsia]
Measured: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Occurrence of Preterm Birth
Preterm birth (< 37+0 weeks GA) during current study pregnancy
Measured: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Small for Gestational Age (SGA) Size
Birthweight <10th centile for gestational age
Measured: At delivery of infant
Occurrence of Perinatal Mortality
Intrauterine fetal demise (IUFD) [absence of FHR at or after 20 weeks' gestation] or Neonatal Death (NND) [death before 28 days of life, following live birth]
Measured: During pregnancy (until delivery of infant, up to 42 weeks of gestation) and up to 28 days after birth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Centre hospitalier de l'Université de Montréal (CHUM), St. Paul's Hospital, Vancouver (Providence Health Care)
- Responsible party
- Sponsor
- Investigators
- A. Kinga Malinowski, MD, MSc, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529042
- Sponsor's protocol ID
- SCRIPT
- Acronym
- SCRIPT
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boafor TK, Olayemi E, Galadanci N, Hayfron-Benjamin C, Dei-Adomakoh Y, Segbefia C, Kassim AA, Aliyu MH, Galadanci H, Tuuli MG, Rodeghier M, DeBaun MR, Oppong SA. Pregnancy outcomes in women with sickle-cell disease in low and high income countries: a systematic review and meta-analysis. BJOG. 2016 Apr;123(5):691-8. doi: 10.1111/1471-0528.13786. Epub 2015 Dec 15.
PubMed 26667608Oteng-Ntim E, Meeks D, Seed PT, Webster L, Howard J, Doyle P, Chappell LC. Adverse maternal and perinatal outcomes in pregnant women with sickle cell disease: systematic review and meta-analysis. Blood. 2015 May 21;125(21):3316-25. doi: 10.1182/blood-2014-11-607317. Epub 2015 Mar 23.
PubMed 25800049Sun PM, Wilburn W, Raynor BD, Jamieson D. Sickle cell disease in pregnancy: twenty years of experience at Grady Memorial Hospital, Atlanta, Georgia. Am J Obstet Gynecol. 2001 May;184(6):1127-30. doi: 10.1067/mob.2001.115477.
PubMed 11349177Yu CK, Stasiowska E, Stephens A, Awogbade M, Davies A. Outcome of pregnancy in sickle cell disease patients attending a combined obstetric and haematology clinic. J Obstet Gynaecol. 2009 Aug;29(6):512-6. doi: 10.1080/01443610903003175.
PubMed 19697199Chou ST, Alsawas M, Fasano RM, Field JJ, Hendrickson JE, Howard J, Kameka M, Kwiatkowski JL, Pirenne F, Shi PA, Stowell SR, Thein SL, Westhoff CM, Wong TE, Akl EA. American Society of Hematology 2020 guidelines for sickle cell disease: transfusion support. Blood Adv. 2020 Jan 28;4(2):327-355. doi: 10.1182/bloodadvances.2019001143.
PubMed 31985807Malinowski AK, Shehata N, D'Souza R, Kuo KH, Ward R, Shah PS, Murphy K. Prophylactic transfusion for pregnant women with sickle cell disease: a systematic review and meta-analysis. Blood. 2015 Nov 19;126(21):2424-35; quiz 2437. doi: 10.1182/blood-2015-06-649319. Epub 2015 Aug 24.
PubMed 26302758Vianello A, Vencato E, Cantini M, Zanconato G, Manfrin E, Zamo A, Zorzi F, Mazzi F, Martinelli N, Cavaliere E, Monari F, Venturelli D, Ferrara F, Olivieri O, De Franceschi L. Improvement of maternal and fetal outcomes in women with sickle cell disease treated with early prophylactic erythrocytapheresis. Transfusion. 2018 Sep;58(9):2192-2201. doi: 10.1111/trf.14767. Epub 2018 Jul 8.
PubMed 29984534Chou ST. Transfusion therapy for sickle cell disease: a balancing act. Hematology Am Soc Hematol Educ Program. 2013;2013:439-46. doi: 10.1182/asheducation-2013.1.439.
PubMed 24319217Kacker S, Ness PM, Savage WJ, Frick KD, Shirey RS, King KE, Tobian AA. Economic evaluation of a hypothetical screening assay for alloimmunization risk among transfused patients with sickle cell disease. Transfusion. 2014 Aug;54(8):2034-44. doi: 10.1111/trf.12585. Epub 2014 Feb 27.
PubMed 24571485Yazdanbakhsh K, Ware RE, Noizat-Pirenne F. Red blood cell alloimmunization in sickle cell disease: pathophysiology, risk factors, and transfusion management. Blood. 2012 Jul 19;120(3):528-37. doi: 10.1182/blood-2011-11-327361. Epub 2012 May 4.
PubMed 22563085Balbuena-Merle R, Hendrickson JE. Red blood cell alloimmunization and delayed hemolytic transfusion reactions in patients with sickle cell disease. Transfus Clin Biol. 2019 May;26(2):112-115. doi: 10.1016/j.tracli.2019.02.003. Epub 2019 Feb 22.
PubMed 30857806Danaee A, Inusa B, Howard J, Robinson S. Hyperhemolysis in Patients With Hemoglobinopathies: A Single-Center Experience and Review of the Literature. Transfus Med Rev. 2015 Oct;29(4):220-30. doi: 10.1016/j.tmrv.2015.06.001. Epub 2015 Jun 19.
PubMed 26209603Tavares AHJ, Benites BD, Fertrin KY. Myocardial Iron Overload in Sickle Cell Disease: A Rare But Potentially Fatal Complication of Transfusion. Transfus Med Rev. 2019 Jul;33(3):170-175. doi: 10.1016/j.tmrv.2019.04.001. Epub 2019 May 2.
PubMed 31153715Silva 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.
PubMed 30030929Malinowski 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.
PubMed 34124774
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Adverse Outcomes in Pregnancies of Individuals With Sickle Cell Disease - SCRIPT: Sickle Cell Risk in Pregnancy Tool
- ClinicalTrials.gov ID
- NCT06529042
- Acronym / sponsor ID
- SCRIPT / SCRIPT
- Keywords
- Risk Assessment, Bayesian Prediction
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Centre hospitalier de l'Université de Montréal (CHUM), St. Paul's Hospital, Vancouver (Providence Health Care)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sickle Cell Disease (SCD) is the most common haemoglobinopathy; predominantly affecting persons of African descent(1). 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 stillbirth(2,3). 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 SCD(4,5). These admissions are most commonly secondary to vaso-occlusive events or anemia, can occur on multiple occasions, and can last days to months(4,5).
During pregnancy, red blood cell (RBC) transfusion remains the only recommended intervention(6), with some evidence suggesting that prophylactic transfusion may modify adverse pregnancy outcomes (APOs)(7,8), 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 complications(9), transfusion in SCD is associated with alloimmunization rates of over 30%(10-12), can induce life-threatening hyperhemolysis(13), and will eventually lead to iron overload(14). At the same time, up to 30% of pregnancies in individuals with SCD remain uncomplicated(2,3,15,16).
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 transfusion(16). 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 model(s) 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 model(s) 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnancies of Individuals with Sickle Cell Disease | – | Other: Non-Interventional |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pregnant Individuals with Sickle Cell Disease (HbSS, HbSC, HbS/β0-thalassemia, HbS/β+-thalassemia)
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Inability to confirm SCD genotype
- Incomplete medical records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | Pregnancies of Individuals with Sickle Cell Disease |
Primary outcome
Presence of Adverse Pregnancy Outcome
Time frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
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.
16 secondary outcomes
Presence of Acute Anemia
Time frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Cardiac Complications
Time frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Pulmonary Complications
Time frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Hepato-Biliary Complications
Time frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Musculo-Skeletal Complications
Time frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Neurologic Complications
Time frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Renal Complications
Time frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Multi-Organ Failure
Time frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Venous Thromboembolism
Time frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Vaso-Occlusive Event with Admission
Time frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Provision of Red Blood Cell Transfusion
Time frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Occurrence of Maternal Mortality
Time frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation) and continuing to 6 months postpartum
Presence of Hypertensive Disorder of Pregnancy
Time frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Occurrence of Preterm Birth
Time frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation)
Presence of Small for Gestational Age (SGA) Size
Time frame: At delivery of infant
Occurrence of Perinatal Mortality
Time frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation) and up to 28 days after birth)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Background: PubMed 26667608Boafor TK, Olayemi E, Galadanci N, Hayfron-Benjamin C, Dei-Adomakoh Y, Segbefia C, Kassim AA, Aliyu MH, Galadanci H, Tuuli MG, Rodeghier M, DeBaun MR, Oppong SA. Pregnancy outcomes in women with sickle-cell disease in low and high income countries: a systematic review and meta-analysis. BJOG. 2016 Apr;123(5):691-8. doi: 10.1111/1471-0528.13786. Epub 2015 Dec 15.
- Background: PubMed 25800049Oteng-Ntim E, Meeks D, Seed PT, Webster L, Howard J, Doyle P, Chappell LC. Adverse maternal and perinatal outcomes in pregnant women with sickle cell disease: systematic review and meta-analysis. Blood. 2015 May 21;125(21):3316-25. doi: 10.1182/blood-2014-11-607317. Epub 2015 Mar 23.
- Background: PubMed 11349177Sun PM, Wilburn W, Raynor BD, Jamieson D. Sickle cell disease in pregnancy: twenty years of experience at Grady Memorial Hospital, Atlanta, Georgia. Am J Obstet Gynecol. 2001 May;184(6):1127-30. doi: 10.1067/mob.2001.115477.
- Background: PubMed 19697199Yu CK, Stasiowska E, Stephens A, Awogbade M, Davies A. Outcome of pregnancy in sickle cell disease patients attending a combined obstetric and haematology clinic. J Obstet Gynaecol. 2009 Aug;29(6):512-6. doi: 10.1080/01443610903003175.
- Background: PubMed 31985807Chou ST, Alsawas M, Fasano RM, Field JJ, Hendrickson JE, Howard J, Kameka M, Kwiatkowski JL, Pirenne F, Shi PA, Stowell SR, Thein SL, Westhoff CM, Wong TE, Akl EA. American Society of Hematology 2020 guidelines for sickle cell disease: transfusion support. Blood Adv. 2020 Jan 28;4(2):327-355. doi: 10.1182/bloodadvances.2019001143.
- Background: PubMed 26302758Malinowski AK, Shehata N, D'Souza R, Kuo KH, Ward R, Shah PS, Murphy K. Prophylactic transfusion for pregnant women with sickle cell disease: a systematic review and meta-analysis. Blood. 2015 Nov 19;126(21):2424-35; quiz 2437. doi: 10.1182/blood-2015-06-649319. Epub 2015 Aug 24.
- Background: PubMed 29984534Vianello A, Vencato E, Cantini M, Zanconato G, Manfrin E, Zamo A, Zorzi F, Mazzi F, Martinelli N, Cavaliere E, Monari F, Venturelli D, Ferrara F, Olivieri O, De Franceschi L. Improvement of maternal and fetal outcomes in women with sickle cell disease treated with early prophylactic erythrocytapheresis. Transfusion. 2018 Sep;58(9):2192-2201. doi: 10.1111/trf.14767. Epub 2018 Jul 8.
- Background: PubMed 24319217Chou ST. Transfusion therapy for sickle cell disease: a balancing act. Hematology Am Soc Hematol Educ Program. 2013;2013:439-46. doi: 10.1182/asheducation-2013.1.439.
- Background: PubMed 24571485Kacker S, Ness PM, Savage WJ, Frick KD, Shirey RS, King KE, Tobian AA. Economic evaluation of a hypothetical screening assay for alloimmunization risk among transfused patients with sickle cell disease. Transfusion. 2014 Aug;54(8):2034-44. doi: 10.1111/trf.12585. Epub 2014 Feb 27.
- Background: PubMed 22563085Yazdanbakhsh K, Ware RE, Noizat-Pirenne F. Red blood cell alloimmunization in sickle cell disease: pathophysiology, risk factors, and transfusion management. Blood. 2012 Jul 19;120(3):528-37. doi: 10.1182/blood-2011-11-327361. Epub 2012 May 4.
- Background: PubMed 30857806Balbuena-Merle R, Hendrickson JE. Red blood cell alloimmunization and delayed hemolytic transfusion reactions in patients with sickle cell disease. Transfus Clin Biol. 2019 May;26(2):112-115. doi: 10.1016/j.tracli.2019.02.003. Epub 2019 Feb 22.
- Background: PubMed 26209603Danaee A, Inusa B, Howard J, Robinson S. Hyperhemolysis in Patients With Hemoglobinopathies: A Single-Center Experience and Review of the Literature. Transfus Med Rev. 2015 Oct;29(4):220-30. doi: 10.1016/j.tmrv.2015.06.001. Epub 2015 Jun 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
A. Kinga Malinowski, MD, MSc principal investigator
MOUNT SINAI HOSPITAL
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease and Pregnancy, High Risk, run by Mount Sinai Hospital, Canada at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Adverse Pregnancy Outcome (time frame: During pregnancy (until delivery of infant, up to 42 weeks of gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06529042, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.