Protocols for Magnesium Sulfate Maintenance Dose in Overweight and Obese Women Diagnosed With Preeclampsia

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorAin Shams University

About this trial

There is still no evidence of the appropriate dose to be used. Serum magnesium sulfate concentration is not measured regularly, thus we may be using sub-therapeutic level or reaching a toxic level.Overweight and obese women have different pharmacokinetics and different drug distribution, therefore, they may need higher doses of magnesium sulfate to reach therapeutic level.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 20-40 years

BMI >25kg/m2

Gestational age > 28 weeks

Disqualifiers

Intrauterine Fetal Death (IUFD)

Hemolysis - Elevated liver enzymes - Low platelets syndrome (HELLP)

Contraindication to Magnesium Sulfate such as myasthenia gravis, severe renal failure, cardiac ischemia, and heart block

Serum creatinine levels greater than 1.1 mg/dL.

Trial design

Design model

Parallel

Treatments tested in this trial

  • maintenance magnesium sulphate1g/h

    Drug

    Women will receive a routine loading infusion of 5 g of MgSO4 over 20 minutes, followed by a maintenance dose rate of 1 g/h.

  • maintenance magnesium sulphate2g/h

    Drug

    Women will receive a routine loading infusion of 5 g of MgSO4 over 20 minutes, followed by a maintenance dose rate of 2 g/h.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Magnesium Sulphate 1g/hrActive comparator 1 intervention
Group B: Magnesium Sulphate 2g/hrActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

serum magnesium level

Maternal Serum Magnesium Level after 24 hours of magnesium sulphate infusion

Time frame
24 hours

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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