Sickle Cell DiseaseSCOB-IINCT05143021
Sickle Cell Disease Obstetric Multi-Disciplinary Care Programme
An observational study of Sickle Cell Disease and Pregnancy Related, run by Vanderbilt University Medical Center at 3 sites in Ghana.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Sickle Cell Disease, Pregnancy Related
- What is being tested?
- Multidisciplinary Sickle Cell Disease- Obstetric Team
- How many people
- 500 participants
- Where
- 3 sitesGhana
- Study dates
- 14 Feb 2022to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women and their health care providers living with SCD in Ghana (Accra-Tema metropolis and Tamale).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Ghana3 sites
Greater Accra Regional Hospital
Accra
Korle Bu Teaching Hospital
Accra
Tamale Teaching Hospital
Tamale
About this study
Official title: Sickle Cell Disease Obstetric Multi-Disciplinary Care Programme: Prospective Multi-Centre Cohort Study
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.
Read the 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:
- 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.
- 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.
- Conditions
- Sickle Cell Disease, Pregnancy Related
- Being tested
- Multidisciplinary Sickle Cell Disease- Obstetric Team
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary Sickle Cell Disease- Obstetric TeamOther
Modified multidisciplinary teams for pregnant women with sickle cell disease including members from an obstetrics team and sickle cell disease team.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women with Sickle Cell Disease | Pregnant women with sickle cell disease from the 3 centers in Ghana Receives: Other: Multidisciplinary Sickle Cell Disease- Obstetric Team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal and Perinatal Mortality Rates
Change in maternal and perinatal mortality rates in the pre-implementation and post-implementation phases.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline- 6 weeks post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start14 Feb 2022
- Primary completion28 Feb 2026
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael DeBaun, Vanderbilt University Medical Center
- Investigators
- Leshana St. Jean, PhD, Study director, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143021
- Sponsor's protocol ID
- 211778
- Acronym
- SCOB-II
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sickle Cell Disease Obstetric Multi-Disciplinary Care Programme: Prospective Multi-Centre Cohort Study
- ClinicalTrials.gov ID
- NCT05143021
- Acronym / sponsor ID
- SCOB-II / 211778
- Conditions
- Sickle Cell Disease, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women with Sickle Cell Disease | – | Other: Multidisciplinary Sickle Cell Disease- Obstetric TeamPregnant women with sickle cell disease from the 3 centers in Ghana |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women and their health care providers living with SCD in Ghana (Accra-Tema metropolis and Tamale).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary Sickle Cell Disease- Obstetric TeamModified multidisciplinary teams for pregnant women with sickle cell disease including members from an obstetrics team and sickle cell disease team. | Other | Pregnant Women with Sickle Cell Disease |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leshana St. Jean, PhD study director
Vanderbilt University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease and Pregnancy Related, run by Vanderbilt University Medical Center at 3 sites in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal and Perinatal Mortality Rates (time frame: Baseline- 6 weeks post delivery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.