A comparative study of 12 hour versus 24 hour Modified Pritchard regimen in the management of Eclampsia and Preeclampsia

Not Applicable

Completed

Conditions: Circulatory System
Pregnancy and Childbirth
Preeclampsia and Eclampsia

Registration Number: PACTR201811515303983

Lead Sponsor: niversity of Michigan

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 730

Inclusion Criteria

1.Antepartum, intrapartum, or postpartum eclampsia with a blood pressure of 140/90 mm Hg or higher after 20 weeks of pregnancy; proteinuria with a dipstick value of +1 or higher; and seizures not attributed to other causes among women with preeclampsia.
2.Severe preeclampsia with diastolic BP=110 mmHg on two occasions or systolic BP =160 mmHg plus at least 2 or more symptoms of imminent eclampsia
3.Patients who have documentation of having received loading dose of MgSO4 at referral clinics prior to referral will be eligible for randomization if they otherwise

Exclusion Criteria

1.Eclampsia with complications (e.g. acute renal failure, HELLP syndrome [hemolysis, elevated liver enzymes, and low platelet count], or pulmonary edema) or
2.Patients with underlying renal disease
3.Contraindication to MgSO4 (e.g. drug hypersensitivity, myasthenia gravis, anuria, or oliguria),
4.Prior intake of any other anticonvulsant, and a history of epilepsy.
5.Refusal to give consent or unable to give consent (eg unconscious)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the occurrence of a fit any time after the completion of the third maintenance dose (MD3) after delivery or last fit, in the study arm or the 6th maintenance dose (MD6) after delivery or last fit in the control arm till 6th week postpartum).

Secondary Outcome Measures

Name	Time	Method
The time interval (in hours) from initiation of treatment to the development of diuresis. (Diuresis will be defined as urine output > 400ml/4 hrs);Clinical evidence of toxicity (Absent tendon reflexes, RR <16cpm, coma);Development acute renal failure (urine output <25 mls/hr) after initiation of treatment;Clinically documented pulmonary oedema;Maternal death;Cerebrovascular accident (stroke);Perinatal death;2.5th minute Apgar score;Respiratory distress (necessitating admission to NICU)