Sickle Cell Disease Clinical Trial
— SCOB-IIOfficial title:
Sickle Cell Disease Obstetric Multi-Disciplinary Care Programme: Prospective Multi-Centre Cohort Study
NCT number | NCT05143021 |
Other study ID # | 211778 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 14, 2022 |
Est. completion date | January 1, 2026 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Ghana | Greater Accra Regional Hospital | Accra | |
Ghana | Korle Bu Teaching Hospital | Accra | |
Ghana | Tamale Teaching Hospital | Tamale |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
Ghana,
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 |
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