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Sickle Cell Disease Obstetric Multi-Disciplinary Care Programme (SCOB-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05143021
Recruitment Status : Recruiting
First Posted : December 3, 2021
Last Update Posted : April 15, 2022
Sponsor:
Information provided by (Responsible Party):
Michael DeBaun, Vanderbilt University Medical Center

Brief 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.

Condition or disease Intervention/treatment
Sickle Cell Disease Pregnancy Related Other: Multidisciplinary Sickle Cell Disease- Obstetric Team

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sickle Cell Disease Obstetric Multi-Disciplinary Care Programme: Prospective Multi-Centre Cohort Study
Actual Study Start Date : February 14, 2022
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : January 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Group/Cohort Intervention/treatment
Pregnant Women with Sickle Cell Disease
Pregnant women with sickle cell disease from the 3 centers in Ghana
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.




Primary Outcome Measures :
  1. Maternal and Perinatal Mortality Rates [ Time Frame: Baseline- 6 weeks post delivery ]
    Change in maternal and perinatal mortality rates in the pre-implementation and post-implementation phases.

  2. The Fidelity to the Evidence-Based Guidelines [ Time Frame: Baseline- 6 weeks post delivery ]
    Fidelity to the evidence-based guidelines for the prevention of acute chest syndrome in pregnant women with SCD utilizing a questionnaire.

  3. Participants with Acute Chest Syndrome [ Time Frame: Baseline- 6 weeks post delivery ]
    The proportion of participants with ACS (based on diagnostic criteria) who are appropriately identified and treated.

  4. The Fidelity to the Standardized Ultrasound Protocol [ Time Frame: Baseline- 6 weeks post delivery ]
    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.

  5. Maternal Nutrition Supply Association to Fetus [ Time Frame: Baseline- 6 weeks post delivery ]
    Affect of maternal nutrition supply on fetus (maternal diet, cataloged in a questionnaire) on birth weight and adverse birth outcomes.

  6. Maternal Nutrition Supply Association to Fetus [ Time Frame: Baseline- 6 weeks post delivery ]
    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.

  7. Maternal Nutrition Supply Association to Fetus [ Time Frame: Baseline- 6 weeks post delivery ]
    Affect of maternal nutrition supply on fetus (gestational weight gain, measured in kilograms) on birth weight and adverse birth outcomes.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women and their health care providers living with SCD in Ghana (Accra-Tema metropolis and Tamale).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05143021


Contacts
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Contact: Michael DeBaun, MD, MPH 615-875-3040 m.debaun@vumc.org
Contact: Maya Chopra, BA 614-915-6974 maya.chopra.1@vumc.org

Locations
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Ghana
Greater Accra Regional Hospital Not yet recruiting
Accra, Ghana
Contact: Kojo Apea-Kubi, MBBS, FGCPS       kojoapeakubi@gmail.com   
Korle Bu Teaching Hospital Recruiting
Accra, Ghana
Contact: Sam Oppong, MB, FWACS       saoppong@ug.edu.gh   
Tamale Teaching Hospital Recruiting
Tamale, Ghana
Contact: Hawa Malechi, MBBS, MGCPS       hazumpoah@yahoo.com   
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Study Director: Leshana St. Jean, PhD Vanderbilt University Medical Center
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Responsible Party: Michael DeBaun, Director of Vanderbilt-Meharry Center of Excellence for Sickle Cell Disease, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT05143021    
Other Study ID Numbers: 211778
First Posted: December 3, 2021    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn