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

Phase 3

Conditions: Health Condition 1: null- Pregnant women with severe preeclampsia

Registration Number: CTRI/2016/07/007076

Lead Sponsor: DirectorPGIMER Chandigarh

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 240

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 <500 mL in 24 hours );

•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

•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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures