Safety and Efficacy of Twelve Hours Duration of MgSO4 in the Treatment of Eclampsia in Low Resource Setting in Sudan

Gadarif University

Status: Unknown

Conditions: Pre-Eclampsia

Treatments: Drug: Adminstration of magnesium Sulphate for treatment of eclampsia

Study type: Interventional

Funder types: Other

Identifiers

NCT03112551

GadarifU

Details and patient eligibility

About

the investigators assume that magnesium sulphate for treating eclampsia can be safely reduced from 24 hours to shorter duration of therapeutic anticonvulsant effect for 12 hours. Short duration of drug exposure is suitable for low resource setting where there is little tools or busy staff for monitoring drug toxicity.

Full description

The idea of using 12 hours duration of magnesium sulphate for treating eclampsia may be effective and attractive, especially in settings with limited resources and where there is no availability of tools to monitor the serum level of magnesium sulphate. This is because the most common reported maternal adverse effects of magnesium sulphate are minor and may be confused with other symptom of eclampsia of even labor.The administration of Magnesium sulphate for 24 hours in the absence of monitoring of the serum magnesium sulphate might be life threatening in a resource- challenged situation , thus the current study is planned to be conducted to investigate the efficacy and safety of shorter duration (12 hours) of magnesium sulphate therapy in preventing development of convulsions in cases of eclampsia.

Enrollment: 100 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• clinical diagnosis of eclampsia
• must accept to participate in the study

Exclusion criteria

• epilepsy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

group 1

Active Comparator group

Description:

group one will be treated with 24 hours maintenance dose of magnesium sulphate

Treatment:

Drug: Adminstration of magnesium Sulphate for treatment of eclampsia

group 2

Experimental group

Description:

group 2 will be treated with 12 hours maintenance dose of magnesium sulphate

Treatment:

Drug: Adminstration of magnesium Sulphate for treatment of eclampsia