| CTRI Number |
CTRI/2008/091/000118 [Registered on: 29/07/2008] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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A study to compare the administration of Magnesium Sulphate by the Intramuscular route and the Intravenous route via a special Springfusor pump and to compare the efficacy and side effects of the same. |
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Scientific Title of Study
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Treatment approaches for pre eclampsia in low resource settinga |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Annie Regi |
| Designation |
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| Affiliation |
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| Address |
Professor and Head, Dept of OG Unit III,Christian Medical College and Hospital, Vellore-632004
Dept. of O&G, CMCH, Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
04162283399 |
| Fax |
04162232035 |
| Email |
annieregi@cmcvellore.ac.in |
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Details of Contact Person
Scientific Query
|
| Name |
Annie Regi |
| Designation |
|
| Affiliation |
|
| Address |
Professor and Head, Dept of OG Unit III,Christian Medical College and Hospital, Vellore-632004
Dept. of O&G
Vellore
TAMIL NADU
632004
India |
| Phone |
04162283399 |
| Fax |
04162232035 |
| Email |
annieregi@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Annie Regi |
| Designation |
|
| Affiliation |
|
| Address |
Professor and Head, Dept of OG Unit III,Christian Medical College and Hospital, Vellore-632004
Vellore
TAMIL NADU
632004
India |
| Phone |
04162283399 |
| Fax |
04162232035 |
| Email |
annieregi@cmcvellore.ac.in |
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Source of Monetary or Material Support
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| Gynuity Health Projects
15 East 26th Street, Suite 1617
New York, NY 10010
USA
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Primary Sponsor
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| Name |
Christian Medical College and Hospital, Vellore |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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| Name |
Address |
| Gynuity Health Projects
15 East 26th Street, Suite 1617
New York, NY 10010
USA
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shuchita Mundle |
Dept. of O&G, Nagpur Govt. Medical College |
Dept. of O&G, Govt. Medical College, Nagpur,-
|
09822706087
srmundle@gmail.com |
| Dr.Gagandeep Kang |
Dept. of Obstetrics & Gynaecology, CMCH, Vellore |
CMCH,,Bagayam-632002
Vellore
TAMIL NADU |
01462284294
04162262788
research@cmcvellore.ac.in |
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Details of Ethics Committee
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| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| CMCH, Vellore, Ethics Committee |
Approved |
| Govt. Medical College, Nagpur |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Pre eclampsia, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Intramuscular administration of Magnesium Sulphate As in Pritchard's regimen |
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| Intervention |
Intravenous administration of Magnesium Sulphate via Springfusor pump |
NA |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
 Exhibit systolic blood pressure > 140mm Hg OR a diastolic pressure > 100 mm Hg
 Exhibit proteinuria > 1+;
 Have not given birth, or be 24h or less postpartum
 Exhibit urine output >100 ml or more during the previous 4h or greater than 25 mL/h.
 Agree to comply with study procedures
 Be > 18 years of age
 Give informed consent for study participation
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| ExclusionCriteria |
| Details |
 Eclamptic or seizing at the time of enrollment
 Received magnesium sulfate therapy 24h prior to study enrollment
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Primary outcomes-
 Maternal morbidity
– Respiratory depression (<16 respirations per minute)
– Respiratory arrest
– Pneumonia
– Cardiac arrest
– Coagulopathy
– Renal or liver failure
– Pulmonary edema
– Cerebral Hemorrhage
 Toxicity
– Need for calcium gluconate
– Stopped or reduced treatment due to toxicity
– Stopped or reduced treatment due to side effects
 Side Effects
– Nausea or vomitting
– Flushing of the skin
– Drowsiness
– Confusion
– Muscle weakness
– Pain and Abscesss
 Use of maternal healthcare resources
– Number of days in hospital
– Admission to intensive care unit (ICU)
– Ventilation
– Dialysis
– Staff time
 Use of neonatal resources
– Days in special care baby unit
– Ventilation
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Secondary Outcome
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Target Sample Size
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Total Sample Size="300"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Yet Recruiting |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Magnesium sulphate is the drug of choice for prevention and treating convulsions in severe pre eclampsia and eclampsia1, 2 and though it has been demonstrated to be a safe and effective drug, concerns about the safety of the drug remain. Magnesium sulfate is administered parenterally by IM or IV routes. The IV regimen achieves more stable serum levels of magnesium but requires the use of an infusion pump for safe delivery and has a greater potential for inadvertent overdose. The IM regimen, the standard of care in most hospitals in India, while being potentially more safe, requires repeated painful IM injections. These limitations in administration hinder the widespread use of magnesium sulfate despite its demonstrated benefits.
Thus there is urgent need to develop a system of care that avoids overdose and is acceptable to both patients and providers. A safe and simple system for IV administration3 of magnesium sulfate will facilitate the expansion of use into clinical environments where resources do not currently exist to treat with magnesium sulfate prior to delivery or transfer of care. This new technology may also facilitate the broader use magnesium sulfate particularly for women with less severe pre eclampsia who may benefit from prophylactic treatment
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