Sickle Cell Disease Obstetric Multi-Disciplinary Care Programme

NCT05143021 | Active Not Recruiting DMC

• 1 other identifier: 211778
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

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.

Conditions

Sickle Cell Disease; Pregnancy Related

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

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

Interventions

Multidisciplinary Sickle Cell Disease- Obstetric Team OTHER

Modified multidisciplinary teams for pregnant women with sickle cell disease including members from an obstetrics team and sickle cell disease team.

Pregnant Women with Sickle Cell Disease

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women and their health care providers living with SCD in Ghana (Accra-Tema metropolis and Tamale).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (3)

Greater Accra Regional Hospital

Accra, Ghana

Location

Korle Bu Teaching Hospital

Accra, Ghana

Location

Tamale Teaching Hospital

Tamale, Ghana

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

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

Study Officials

• Leshana St. Jean, PhD

  Vanderbilt University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Vanderbilt-Meharry Center of Excellence for Sickle Cell Disease

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 3, 2021
• Study Start: February 14, 2022
• Primary Completion: February 28, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GH (3)