Multi Disciplinary Sickle Cell Disease Obstetrics Care Program in Ghana

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Ghana Medical School

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Multidisciplinary sickle cell disease (SCD) obstetrics program for women with SCD in a non-academic hospital.

    Other intervention

    Pregnant women with sickle cell disease

Treatment groups

198 Participants
are divided into 1 treatment group
Group A: Hybrid type-1 feasibility studyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maternal mortality

Maternal mortality in women with sickle cell disease

Time frame
Up to 40 weeks for each participant

Secondary outcomes

Other outcomes

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