Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease

Number of participants who require hospital admission during study participation divided by the total number of participants. Collected from medical records

Collected from medical records

Sickle cell complications (vaso-occlusive crisis (VOC) / acute chest syndrome (ACS) / cerebral stroke) collected from medical records

Number of participants who will develop pregnancy-related complications (pre-eclampsia, venous thromboembolism, infection). Collected from medical records

Number of women who die at any gestational age during pregnancy or within 8 weeks after delivery from any cause arising from the pregnancy or its management, but not from incidental or accidental causes, divided by the total number of participants.

The Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) is a validated patient-reported outcome measure of physical, mental, and social health in adults with SCD. Patient-reported outcome measure of pain level in the past 7 days. The ASCQ-Me pain scale ranges from 0-100, with a standardized sickle cell disease population mean of 50 (standard deviation=10), where lower scores signify worse disease impact. A modified version of the validated ASCQ-Me will be used.

The patient-reported outcomes will be assessed using a health-related quality of life questionnaire, a modified version of the validated sickle-cell specific quality of life instruments, PROMIS

The PROMIS Short-Form scale is a generic measure of health-related quality of life (HRQL) that assesses physical, mental, and social health. It has a recall period of 7 days and yields separate Physical Health and Mental Health subscale scores, which range from 0 to 100 and are standardized to a US population mean of 50 and standard deviation (SD) of 10. Each question usually has five response options ranging in value from one to five. To find the total raw score for a short form with all questions answered, sum up the values of the responses to each question. For example, for the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40. For each subscale, a higher score connotes better functioning.

Infant's birth weight from medical records.

Number of women delivered before 37 weeks gestational age divided by the total number of participants randomized.

The Apgar score is a scoring system doctors and nurses use to assess newborns after delivery. At most, a child will receive an overall score of 10. A score of 7 to 10 five minutes after birth is reassuring, 4 to 7 is moderately abnormal, and 0 to 3 is concerning. The Apgar scoring system is divided into five categories. Each category receives a score of 0 to 2 points.

A: Activity/muscle tone P: Pulse/heart rate G: Grimace (response to stimulation, such as suctioning the baby's nose) A: Appearance (color) R: Respiration/breathing

The neonate's admission to the intensive care unit/critical care admission will be documented from medical records.

Number of babies who died from 28 weeks gestational age up to seven days post-delivery (comprising all still births and early neonatal deaths divided by total births.

Fetal demise refers to the spontaneous intrauterine death of a fetus at any time during pregnancy.

Participants who have been assigned to receive chronic simple blood transfusions will have monthly labs prior to their scheduled transfusion as per SOC to assess for new alloantibodies.

Participants will be carefully monitored for transfusion-related adverse events throughout the intervention phase of the study.

Transfusion iron burden will be monitored with monthly serum ferritin levels during the study, which is standard of care monitoring for patients undergoing chronic transfusion therapy.