Severe Preeclampsia Clinical Trial
Official title:
Efficacy and Safety of One Gram Versus Two Grams Intravenous Maintenance Dose of Magnesium Sulfate in Women With Severe Pre-eclampsia: a Randomized Clinical Trial.
Preeclampsia is commonly viewed as one of the hypertensive pregnancy disorders, which cover a spectrum of clinical presentations from chronic hypertension ( hypertension occurring prior to 20 weeks of gestation) and gestational hypertension (hypertension occurring after 20 weeks of gestation) To more severe forms, including preeclampsia, eclampsia (its convulsive form), and HELLP syndrome (hemolysis, elevated liver enzyme S, and low platelets)
Treatment for patients who have developed preeclampsia or eclampsia mainly consists of
control of hypertension, magnesium sulphate for prevention of eclampsia and convulsions, and
planning for delivery.
Magnesium sulfate has been used to prevent eclamptic convulsion since 1925, its efficacy was
confirmed by a large randomized controlled trial in 2002. Eclampsia could be prevented in
more than 50% after magnesium sulfate administration . The World Health Organization
recommended magnesium sulfate as the most effective, safe, and low-cost drug for the
prevention of seizure in severe preeclampsia and eclampsia . The recommended dose of
magnesium sulfate is 4 to 6 gram intravenous loading dose, followed by maintenance
intravenous drip at the rate of 1 to 2 gram per hour .
Although different magnesium sulfate regimens have been tested, two dosing regimens are
internationally recommended and widely used. The Pritchard regimen is a predominantly
intramuscular regimen given as a loading dose of 4 g intravenously , and 5 g Intramuscular
into each buttock followed by a maintenance dose of 5 g Intramuscular every 4 hours. This
regimen is popular in resource-limited settings where intravenously administration of
magnesium sulfate may not be feasible. However, it is associated with pain and a higher risk
of infection at the injection site.
The Zuspan regimen is given as a 4 gram intravenously loading dose followed by continuous
intravenously infusion of 1 gram per hour.
Either 1 gram or 2 gram maintenance dose of Magnesium Sulphate has been reported to reduce
the development of eclampsia. Randomized controlled trials offering direct comparison between
these 2 doses are lacking.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04725812 -
Complement Regulation to Undo Systemic Harm in Preeclampsia
|
Phase 2 | |
| Active, not recruiting |
NCT03744988 -
Serum Androgen Levels as a Marker for the Severity of Preeclampsia
|
||
| Completed |
NCT02189148 -
First-trimester Prediction of Preeclampsia
|
||
| Completed |
NCT04058405 -
Risk Prediction Models for Adverse Maternal and Neonatal Outcomes in Preeclampsia
|
||
| Not yet recruiting |
NCT06265415 -
Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine
|
N/A | |
| Completed |
NCT02379832 -
Pre-Eclampsia And Growth Restriction: a Longitudinal Study
|
||
| Not yet recruiting |
NCT01538121 -
Antiphospholipid Antibodies and Early Severe Preeclampsia.
|
N/A | |
| Recruiting |
NCT01906567 -
İs There a Relationship Between Severity of Preeclampsia and Maternal Heavy Metal Levels?
|
N/A | |
| Recruiting |
NCT01382732 -
Carbetocin vs. Oxytocin for Prevention of Postpartum Bleeding in Patients With Severe Preeclampsia
|
Phase 3 | |
| Completed |
NCT01408979 -
Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia
|
Phase 4 | |
| Completed |
NCT01538147 -
Restless Leg Syndrome and Severe Preeclampsia
|
N/A | |
| Terminated |
NCT03008616 -
Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia
|
Phase 2/Phase 3 |