Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201811515303983 Date of Approval: 09/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparative study of 12 hour versus 24 hour Modified Pritchard regimen in the management of Eclampsia and Preeclampsia
Official scientific title A comparative study of 12 hour versus 24 hour Modified Pritchard regimen in the management of Eclampsia and Preeclampsia
Brief summary describing the background and objectives of the trial Background: Hypertensive disorders continue to be a major contributor to maternal and perinatal morbidity and mortality. In some developing countries, hypertensive disorders have overtaken haemorrhage as the leading cause of maternal mortality. Magnesium sulfate therapy is the standard of care for seizure prophylaxis in preeclampsia and eclampsia, but its mechanism of action and pharmacokinetics is not well understood. The optimal dose and dosing frequency of magnesium sulfate is unknown. Though some standard regimens including the Pritchard have been used in the clinical setting for several decades, they are at best empirical lacking exposure-response data in humans. Aim: To compared the clinical efficacy of the 12-hour versus 24-Hour Modified Prichard regimen of Magnesium sulfate in the management of preeclampsia and eclampsia
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MOPEP
Disease(s) or condition(s) being studied Circulatory System,Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Preeclampsia and Eclampsia
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/11/2018
Actual trial start date 15/11/2018
Anticipated date of last follow up 14/11/2020
Actual Last follow-up date 30/11/2020
Anticipated target sample size (number of participants) 730
Actual target sample size (number of participants) 1176
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Modified Pritchard regimen Loading dose of 14 g of MgSO4 (consisting of 4 g IV and 10 g IM), followed by a maintenance dose of 5g 4 hourly for 12 hours after the last fit or delivery (whichever occurred later). 12 hours participants receive 12 hours of magnesium sulfate as maintenance after the last fit or delivery (whichever occurred later) 265
Control Group Pritchard regimen a. Loading dose of 14 g of MgSO4 (consisting of 4 g IV and 10 g IM), followed by a maintenance dose of 5g 4 hourly for 24 hours after the last fit or delivery (whichever occurred later). 24 hours 24 hours after delivery or last fit (which occurred later) 265 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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) Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 13 Year(s) 49 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/08/2018 KORLE BU TEACHING HOSPITAL INSTITUTIONAL REVIEW BOARD
Ethics Committee Address
Street address City Postal code Country
GUGGISBERG AVENUE Accra 0077 Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/06/2019 KORLE BU TEACHING HOSPITAL INSTITUTIONAL REVIEW BOARD
Ethics Committee Address
Street address City Postal code Country
GUGGISBERG AVENUE ACCRA 0077 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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). After the last maintenance dose for each each group
Secondary Outcome The time interval (in hours) from initiation of treatment to the development of diuresis. (Diuresis will be defined as urine output > 400ml/4 hrs) from initiation of treatment till discharge from hospital
Secondary Outcome Clinical evidence of toxicity (Absent tendon reflexes, RR <16cpm, coma) from initiation of treatment till discharge from hospital
Secondary Outcome Development acute renal failure (urine output <25 mls/hr) after initiation of treatment from initiation of treatment till discharge from hospital
Secondary Outcome Clinically documented pulmonary oedema from initiation of treatment till discharge from hospital
Secondary Outcome Maternal death from initiation of treatment till 6th week postpartum
Secondary Outcome Cerebrovascular accident (stroke) from initiation of treatment till 6th week postpartum
Secondary Outcome Perinatal death from recruitment till 1st post delivery
Secondary Outcome 2. 5th minute Apgar score at birth
Secondary Outcome Respiratory distress (necessitating admission to NICU) from birth till discharge from NICU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KORLE BU TEACHING HOSPITAL GUGGISBERG AVENUE ACCRA Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Michigan 10090 WOLVERINE TOWER, 3003 S. STATE ST ANN ARBOR 48109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Michigan 10090 WOLVERINE TOWER, 3003 S. STATE ST ANN ARBOR 48109 United States of America University
COLLABORATORS
Name Street address City Postal code Country
EMMA LAWRENCE 10090 WOLVERINE TOWER, 3003 S. STATE ST ANN ARBOR United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator TITUS BEYUO drbeyuo@gmail.com +233200284332 Guggisberg avenue
City Postal code Country Position/Affiliation
Accra Ghana Korle Bu Teaching Hospital
Role Name Email Phone Street address
Public Enquiries TITUS BEYUO drbeyuo@gmail.com +233200284332 Guggisberg avenue
City Postal code Country Position/Affiliation
Accra Ghana Korle Bu Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries TITUS BEYUO drbeyuo@gmail.com +233200284332 Guggisberg avenue
City Postal code Country Position/Affiliation
Accra Ghana Korle Bu Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information