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Trial record 6 of 33 for:    Sudan

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

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ClinicalTrials.gov Identifier: NCT03112551
Recruitment Status : Enrolling by invitation
First Posted : April 13, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
AbdelAziem AbdAllah Ali, Gadarif University

Brief Summary:
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.

Condition or disease Intervention/treatment
Pre-Eclampsia Drug: Adminstration of magnesium Sulphate for treatment of eclampsia

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Twelve Hours Duration of Magnesium Sulphate in the Treatment of Eclampsia in Low Resource Setting in Sudan
Anticipated Study Start Date : December 1, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: group 1
group one will be treated with 24 hours maintenance dose of magnesium sulphate
Drug: Adminstration of magnesium Sulphate for treatment of eclampsia
A total of 100 eclamptic patients are suspected to be approached alternately and subcategorized into two groups - one group will be treated with 24 hours maintenance dose of magnesium sulphate (Group-1; n=50), and the other with 12 hours maintenance dose of magnesium sulphate (Group-2; n=50).
Experimental: group 2
group 2 will be treated with 12 hours maintenance dose of magnesium sulphate
Drug: Adminstration of magnesium Sulphate for treatment of eclampsia
A total of 100 eclamptic patients are suspected to be approached alternately and subcategorized into two groups - one group will be treated with 24 hours maintenance dose of magnesium sulphate (Group-1; n=50), and the other with 12 hours maintenance dose of magnesium sulphate (Group-2; n=50).



Primary Outcome Measures :
  1. Number of patients who will receive magnesium sulfate and develop drug toxicity [ Time Frame: 12 - 24 hours ]
    the adverse effect of magnesium sulphate either minor signs:flushing, increased warmth and sweating, nausea, vomiting, headaches, muscle weakness and blurred vision or major effects such as absent tendon reflexes and oliguria.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • epilepsy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112551


Locations
Sudan
Gadarif University
Gadarif, Sudan
Sponsors and Collaborators
Gadarif University

Responsible Party: AbdelAziem AbdAllah Ali, Prof., Gadarif University
ClinicalTrials.gov Identifier: NCT03112551     History of Changes
Other Study ID Numbers: GadarifU
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents