New Magnesium Sulphate Protocol for Pre-eclampsia

Study Overview
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Brief Summary
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there is a standard magnesium sulphate protocol and newer protocols for pre-eclampsia, we need to make a trial to find the best protocol

Detailed Description
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The aim of our study is to assess the comparative effects of three regimens for the administration of magnesium sulfate when used for the care of women with severe pre-eclampsia. The study will include 240 pregnant women presenting to the casualty unit with criteria of severe preeclampsia in the form of one of the criteria:- Systolic blood pressure ≥ 160. Diastolic blood pressure ≥ 110. Proteinuria > +2 by dip stick. Presence of alarming symptoms (headache, visual disturbance, epigastric pain, vaginal bleeding). Fetal growth restriction (IUGR). After obtaining an informed consent the patients will be subjected to the following: Careful history taking including age, parity, gestational age. Complete physical examination and assessment of the blood pressure. Urine analysis by dipstick. All women will take initial MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes by IV drip) . Using Random Number Table, the sample size will be divided into three categories:- Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period. Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period. Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate. Inclusion criteria: Pregnant females ≥20 weeks of gestation. Pregnant females with criteria of severe pre-eclampsia. Single or multi-fetal pregnancy. Primigravida or Multigravida. Exclusion criteria: Pregnant females < 20 weeks gestation. Pregnant females with history of epilepsy. Pregnant females with diabetes. Pregnant females with chronic hypertension. Pregnant females with renal disease.

Official Title
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The Best Magnesium Sulphate Protocol for Severe Pre-eclampsia : A Randomized Controlled Trial

Conditions
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Pre-eclampsia

Intervention / Treatment
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* Drug: MgSO4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant females ≥20 weeks of gestation. Pregnant females with criteria of severe pre-eclampsia. Single or multi-fetal pregnancy. Primigravida or Multigravida. Exclusion Criteria: Pregnant females < 20 weeks gestation. Pregnant females with history of epilepsy. Pregnant females with diabetes. Pregnant females with chronic hypertension. Pregnant females with renal disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abrreviated MgSO4 protocol<br>- Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period. | Drug: MgSO4<br>* A randomized controlled study that compare three regimens for administration of MgSO4 used for the cases of severe pre-eclampsia that will be performed in the Obstetrics & Gynecology Department, Kasr Al-Ainy Hospital, Cairo University<br>|
| Experimental: No maintenance protocol<br>- Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate | Drug: MgSO4<br>* A randomized controlled study that compare three regimens for administration of MgSO4 used for the cases of severe pre-eclampsia that will be performed in the Obstetrics & Gynecology Department, Kasr Al-Ainy Hospital, Cairo University<br>|
| Active Comparator: standard MgSO4 protocol<br>- Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period. | Drug: MgSO4<br>* A randomized controlled study that compare three regimens for administration of MgSO4 used for the cases of severe pre-eclampsia that will be performed in the Obstetrics & Gynecology Department, Kasr Al-Ainy Hospital, Cairo University<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of MgSo4 treatment | treatment duration | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU admission | ICU admission | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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convulsion rate