New Magnesium Sulphate Protocol for Pre-eclampsia

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Pre-eclampsia

Treatments: Drug: MgSO4

Study type: Interventional

Funder types: Other

Identifiers

NCT01846156

52013 (Registry Identifier)

52103

Details and patient eligibility

About

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

Full description

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.

Enrollment: 240 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 3 patient groups

Abrreviated MgSO4 protocol

Experimental group

Description:

- 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.

Treatment:

Drug: MgSO4

No maintenance protocol

Experimental group

Description:

- 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

Treatment:

Drug: MgSO4

standard MgSO4 protocol

Active Comparator group

Description:

- 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.

Treatment:

Drug: MgSO4