Sickle Cell Disease Obstetric Multi-Disciplinary Care Programme

Sickle Cell Disease Clinical Trial

— SCOB-II  

Official title:

Sickle Cell Disease Obstetric Multi-Disciplinary Care Programme: Prospective Multi-Centre Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05143021
• Other study ID #: 211778
• Status: Recruiting
• Start date: February 14, 2022
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2024
• Source: Vanderbilt University Medical Center
• Contact: Michael DeBaun, MD, MPH
• Phone: 615-875-3040
• Email: m.debaun[@]vumc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To implement an effective but low-cost strategy to decrease SCD maternal and perinatal mortality in Ghana. The objectives are to 1) assess the impact of a multidisciplinary SCD-obstetric team for decreasing mortality across three hospital sites in Ghana. 2) assess the implementation fidelity for 2a) preventing and 2b) treating acute chest syndrome in pregnant women with SCD admitted to the hospital. 3) standardize an ultrasound protocol for the prospective monitoring of fetal growth among pregnant women with SCD.

Description:

Ghana, has a high burden of sickle cell disease (SCD), with a disproportionately high maternal and perinatal morbidity and mortality. In 2015, the investigators established a multidisciplinary SCD Obstetrics team to implement low-technology evidence-based protocols (EBP) to prevent and treat acute chest syndrome (ACS), which is the leading cause of maternal death, institute maternal and fetal monitoring, and ensure better-coordinated care for in-patients. These interventions resulted in an 89.1% risk reduction in maternal mortality over 13 months. The investigators have designed an implementation protocol that allows for the systematic tailoring and implementation of this EBP at facilities that employ few (or no) specialized physicians. The critical and unanswered question is: can the dramatic reduction in maternal and perinatal mortalities observed at KBTH be maintained and replicated with high fidelity at other tertiary hospitals in Ghana? This study, set in a region with the world's highest SCD prevalence, has the potential to impact maternal and neonatal mortality by tailoring evidence-based protocols to facilitate use by non-specialized health care providers. This project has the potential to change the way pregnant women with SCD are managed in Ghana and the rest of sub-Saharan Africa. If successful, this study will form a blueprint for the scale-up of this evidence-based protocol across the country and the West Africa sub-region, where pregnant women with SCD face an uncertain future. Additionally, the project can serve as a model for training clinical researchers, public health, and social scientists in implementation science for major interventions in maternal and perinatal health in Ghana. The investigators propose a standards care prospective protocol to test the following two primary hypotheses: 1. After implementing a hospital-tailored task-shifting intervention program in the tertiary hospitals, there will be a 60% relative risk reduction in maternal mortality among pregnant women with SCD. 2. A. There will be at least a 90% fidelity to evidence-based guidelines for the prevention of ACS for women with SCD at high risk for ACS (acute pain and post-surgery) B. There will be at least a 90% fidelity to evidence-based guidelines for the treatment of ACS for women with SCD at high risk for ACS (acute pain and post-surgery) This will be a multi-center prospective cohort study involving pregnant women with SCD who attend antenatal care at three referral hospitals. Participants will be enrolled from the booking visit over 18 months and managed with the evidence-based clinical guidelines plus multi-disciplinary team standard care protocol and followed up prospectively until delivery and up to six weeks after delivery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• All study participants will be adults between the reproductive ages of 18 to 45 years as defined by World Health Organization (WHO)
• Confirmed SCD status by Hb-electrophoresis in alkaline medium
• Pregnancy should be confirmed by urine or blood pregnancy test and pelvic ultrasound scan.

Exclusion Criteria:

• All pregnant women without a confirmed Hb phenotype or electrophoresis report
• All pregnant women with SCD who present to the Greater Accra Regional Hospital or Tamale Teaching Hospital for acute admissions, labor, and delivery
• All pregnant women with SCD with undetermined Hb phenotypes on Hb electrophoresis.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Pregnancy Related
• Sickle Cell Disease

Intervention

Other:
• Multidisciplinary Sickle Cell Disease- Obstetric Team
Modified multidisciplinary teams for pregnant women with sickle cell disease including members from an obstetrics team and sickle cell disease team.

Locations

Country	Name	City	State
Ghana	Greater Accra Regional Hospital	Accra
Ghana	Korle Bu Teaching Hospital	Accra
Ghana	Tamale Teaching Hospital	Tamale

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal and Perinatal Mortality Rates	Change in maternal and perinatal mortality rates in the pre-implementation and post-implementation phases.	Baseline- 6 weeks post delivery
Primary	The Fidelity to the Evidence-Based Guidelines	Fidelity to the evidence-based guidelines for the prevention of acute chest syndrome in pregnant women with SCD utilizing a questionnaire.	Baseline- 6 weeks post delivery
Primary	Participants with Acute Chest Syndrome	The proportion of participants with ACS (based on diagnostic criteria) who are appropriately identified and treated.	Baseline- 6 weeks post delivery
Primary	The Fidelity to the Standardized Ultrasound Protocol	The fidelity to the standardized ultrasound protocol for detection of Small for Gestational Age (SGA) or Intrauterine Growth Restriction (IUGR) in pregnant women with SCD utilizing a questionnaire.	Baseline- 6 weeks post delivery
Primary	Maternal Nutrition Supply Association to Fetus	Affect of maternal nutrition supply on fetus (maternal diet, cataloged in a questionnaire) on birth weight and adverse birth outcomes.	Baseline- 6 weeks post delivery
Primary	Maternal Nutrition Supply Association to Fetus	Affect of maternal nutrition supply on fetus (pre-pregnancy body mass index, measured in kilograms and height in meters) on birth weight and adverse birth outcomes.	Baseline- 6 weeks post delivery
Primary	Maternal Nutrition Supply Association to Fetus	Affect of maternal nutrition supply on fetus (gestational weight gain, measured in kilograms) on birth weight and adverse birth outcomes.	Baseline- 6 weeks post delivery