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Safety and Efficacy of abbreviated (12 hr) Magnesium Sulfate (MgSO4) therapy) vs. traditional 24 hrs therapy after delivery in Severe Preeclampsia: A Randomized Clinical Trial

: Safety and Efficacy of abbreviated (12 hr) Magnesium Sulfate (MgSO4) therapy) vs. traditional 24 hrs therapy after delivery in Severe Preeclampsia: a Randomized Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/07/007076
Enrollment
240
Registered
2016-07-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Pregnant women with severe preeclampsia

Interventions

Intervention1: 12 hours of magnesium sulfate: Patients in this group will have magnesium sulfate administered for 12 hours after delivery.Mgso4 to be given 14 gm loading dose(5gm in each buttock IM an

Sponsors

DirectorPGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria 1. Women with severe-preeclampsia, diagnosed during ante partum, intrapartum, or postpartum, are eligible for inclusion after delivery. A diagnostic criterion for severe preeclampsia includes: • sustained systolic blood pressure of >=160 mm Hg; • sustained diastolic blood pressure of >=110 mm Hg; • proteinuria >3 + on dipstick or >=5 g/24- hour urine collection; • oliguria (urine output • the presence of persistent headache, visual disturbances, or epigastric or right upper quadrant pain; thrombocytopenia ; impaired liver function; pulmonary edema or cyanosis; • fetal growth retardation; • or superimposed severe pre-eclampsia with pre-existing chronic hypertension. 2. Agree to comply with study procedures; 3. > 18 years of age; 4. Give informed consent for study participation

Exclusion criteria

Exclusion criteria: Exclusion Criteria • Associated maternal diseases; • Use of illicit drugs or other medications that might interfere with maternal hemodynamics; • Contraindications to the use of magnesium sulfate: drug hypersensitivity, oliguria with urine output below 25ml/h; anuria (absent urine output), myasthenia gravis. • Comatosed patients • Pulmonary oedema • Oliguria • Patients who have received MgSO4, Phenytoin, Diazepam before coming to hospital • Intra cranial bleeding

Design outcomes

Primary

MeasureTime frame
1. Maternal: Recurrence of fits, signs of magnesium toxicity like loss of knee jerk, respiratory depression, and any other maternal complications like coagulation failure, oliguria, renal failure, and pulmonary oedema will be recorded. Details of labour and delivery will be recorded.Timepoint: Outcome will be assed till48 hours of delivery

Secondary

MeasureTime frame
2. Serum Magnesium level in maternal bloodTimepoint: at 5 mins, 4 hrs, 12 hrs and 24 hrs

Countries

India

Contacts

Public ContactDr Pradip Kumar Saha

PGIMER, Chandigarh

pradiplekha@yahoo.co.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026