Abstract:
Introduction Hypertensive disorders of pregnancy
continue to be a major contributor to maternal and
perinatal morbidity and mortality. Magnesium sulfate
therapy is the standard of care for seizure prophylaxis and
treatment for pre-eclampsia and eclampsia respectively,
despite wide disparities in dosing regimens and routes of
administration. This study compares the clinical efficacy of
magnesium sulfate in the reduction of seizure occurrence
or recurrence with the 12 hours versus 24 hours modified
Pritchard regimens in the management of severe preeclampsia
and eclampsia.
Methods and analysis This study is an open labelled
randomised controlled trial. The study participants are
patients admitted to the Korle Bu Teaching Hospital
(KBTH) in Accra, Ghana with a diagnosis of antepartum,
intrapartum or postpartum eclampsia or pre-eclampsia
with severe features. All study participants will be
administered a loading dose of magnesium sulfate,
followed by maintenance dosing. Participants in the
control group will receive magnesium sulfate for 24 hours
after diagnosis, while those in the treatment group will
receive magnesium sulfate for 12 hours after diagnosis.
The primary outcome of this study is the occurrence
of a seizure any time after the completion of treatment
in the assigned group. Secondary outcome measures
include maternal health outcomes, magnesium sulfate
toxicities and fetal health outcomes. Data collection
was started in October 2018 with a target enrolment of
1245 participants with severe pre-eclampsia and 844
participants with eclampsia with a projected study period
of 2–3 years.
Ethics and dissemination Ethical approval was obtained
from the KBTH Institutional Review Board (IRB) in Ghana.
University of Michigan involvement is limited to protocol
development and statistical analysis of de-identified data,
and has been granted a Not Regulated Determination
by the University of Michigan IRB. Results of the study
will be shared at clinical forums at the KBTH and will be
submitted for publication in an international peer-reviewed
journal.
