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

NCT06486025 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: Magnesium and Preeclampsia
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Severe Preeclampsia

Outcome Measures

Primary Outcomes (1)

• serum magnesium level

  Maternal Serum Magnesium Level after 24 hours of magnesium sulphate infusion

  24 hours

Study Arms (2)

Magnesium Sulphate 1g/hr

ACTIVE COMPARATOR

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

Drug: maintenance magnesium sulphate1g/h

Magnesium Sulphate 2g/hr

ACTIVE COMPARATOR

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

Drug: maintenance magnesium sulphate2g/h

Interventions

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.

Magnesium Sulphate 1g/hr

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.

Magnesium Sulphate 2g/hr

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women diagnosed with SPET as per criteria of NICE, 2023 guidance
• Age 20-40 years
• BMI \>25kg/m2
• Gestational age \> 28 weeks

You may not qualify if:

• 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.
• Women refusing to participate in the study.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Rehab Hashem

CONTACT

01017830916; rehabhashem66@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 3, 2024
• Study Start: July 1, 2024
• Primary Completion: September 15, 2024
• Study Completion: October 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06