Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05143021

Sickle Cell Disease Obstetric Multi-Disciplinary Care Programme

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Pregnancy Related

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Greater Accra Regional Hospital, Accra, Ghana

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Acronym: SCOB-II

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Dec 3, 2021
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.