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Efficacy and safety of 12-hour versus 24-hour magnesium sulphate maintenance regimen for preventing seizure in women with pre-eclampsia and eclampsia: a randomized controlled study

Efficacy and safety of 12-hour versus 24-hour magnesium sulphate maintenance regimen for preventing seizure in women with pre-eclampsia and eclampsia: a randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
PACTR
Registry ID
PACTR202503856206635
Enrollment
80
Registered
2025-03-31
Start date
2025-04-14
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertensive disorders of pregnancy

Interventions

Twenty four hour magnesium sulphate maintenance injection
Twelve hour magnesium sulphate

Sponsors

Alfa Yusuf
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA. 1. Pregnant women diagnosed with severe pre-eclampsia or eclampsia. 2. Gestational age = 20 weeks. 3. No prior MgSO4 administration before enrolment.

Exclusion criteria

Exclusion criteria: EXCLUSION CRITERIA. Women with pre-eclampsia with severe features or eclampsia with any of the following characteristics will be excluded from the study: • Epilepsy/pre-existing neurological disorders • Hemodynamic instability requiring ICU care • Renal impairment • Acute pulmonary oedema, • Diabetes mellitus and other medical comorbidities. • Hypertensive encephalopathy • Unwilling to give consent for the study • Allergy to magnesium sulphate • Coma

Design outcomes

Primary

MeasureTime frame
Occurrence of seizures in pre-eclamptic and eclamptic patients, in each arm of the study

Secondary

MeasureTime frame
1.Mean Serum Magnesium Levels: 2. Safety Outcomes: a. Maternal mortality and ICU admissions. b. MgSO4 toxicity signs: (i) Loss of deep tendon reflexes (DTRs); (ii) Respiratory depression (10 mg/dL) (v) Death c. Adverse effects (nausea, flushing, hypotension, drowsiness, post-partum seizure duration, time to onset of ambulation, and needle abscess or injection site complications)

Countries

Nigeria

Contacts

Public ContactIkemefuna C Nwosu

Consultant

ikese2001@yahoo.com+2348034780015

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026