About this trial
The goal of this observational study is to determine the feasibility and effectiveness of initiating a multidisciplinary sickle cell disease (SCD) obstetrics program for women with SCD in a non-academic hospital.
The main question it aims to answer is: In a before-and-after study design, we will test the hypothesis that multidisciplinary care for pregnant women with SCD in a non-academic hospital will result in a 50% relative risk reduction in mortality compared to the mortality rate in pregnant women with SCD in the same hospital before the multidisciplinary care.
Participants will be managed using the academic hospital's multidisciplinary sickle cell disease obstetrics protocol adapted for the non-academic hospital
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women with a confirmed laboratory diagnosis of sickle cell disease
Pregnancy confirmed by a pelvic ultrasound scan
Pregnancy should be 34 weeks' gestation or less
Pregnant women should be aged 18 - 45 years
Disqualifiers
All pregnant women with sickle cell disease who do not provide informed consent
All pregnant women with sickle cell disease who are referred for management of acute complications and hospital admission
All pregnant women with sickle cell disease who are referred for labor and delivery
All pregnant women with SCD who plan on delivering outside the non-academic hospital and won't be able to adhere to the follow-up procedures during the puerperium (the first six weeks after childbirth)
Trial design
Single group
Treatments tested in this trial
Multidisciplinary sickle cell disease (SCD) obstetrics program for women with SCD in a non-academic hospital.
Other interventionPregnant women with sickle cell disease
Treatment groups
Trial outcomes
Primary outcomes
Maternal mortality
Maternal mortality in women with sickle cell disease
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Ghana Medical School
Lead sponsor
Vanderbilt University Medical Center
Collaborator
Fogarty International Center of the National Institute of Health
Collaborator