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
Recruiting
- Conditions
- Pregnant women with severe preeclampsia
- Registration Number
- CTRI/2016/07/007076
- Lead Sponsor
- DirectorPGIMER Chandigarh
- Brief Summary
MgSO4 is the ideal drug for seizure prophylaxis in preeclampsia but the ideal duration of this treatment after delivery is still to be established. different schemes have been offered to shorten the exposure to MgSO4 after delivery, with little data. the hypothesis is that in stable patients a short course of treatment is possible without prejudice to the mother. however, there is no consensus on the appropriate duration of prophylactic use of MgSO4 in severe preeclampsia. there fore, the present study has been planed to campare the 12 hrs vs 24 hrs MgSO4 therapy after delivery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 240
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 <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
- 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. Outcome will be assed till48 hours of delivery
- Secondary Outcome Measures
Name Time Method 2.Serum Magnesium level in maternal blood at 5 mins, 4 hrs, 12 hrs and 24 hrs
Trial Locations
- Locations (1)
PGIMER,Chnadigarh
🇮🇳Chandigarh, CHANDIGARH, India
PGIMER,Chnadigarh🇮🇳Chandigarh, CHANDIGARH, IndiaDr PRADIP K SAHAPrincipal investigator919914209341pradiplekha@yahoo.co.in