Ignite Creation Date:
2024-05-06 @ 3:33 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02317146
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2014-12-11
Brief Title:
Magnesium Sulfate in Pregnancy and Postpartum
Sponsor:
Complejo Hospitalario Dr Arnulfo Arias Madrid
Organization:
Complejo Hospitalario Dr Arnulfo Arias Madrid
Study Overview
Official Title:
A Novel Protocol for Postpartum Magnesium Sulfate in Severe Preeclampsia When the Woman Received Less That 8 Hours Before Delivery Six Versus Twenty-four Hours Postpartum
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAG-PP
Brief Summary:
There are huge doubts as to how long to keep postpartum magnesium sulfate Studies demonstrating the usefulness for 24 12 or 6 hours are of little evidence and do not take into account the use of magnesium sulphate before delivery Termination of pregnancy is the best option to prevent eclampsia and magnesium sulphate has proven effective but do not know the minimum effective doseThe investigators believe that if the patient has received less than 8 continuous hours of magnesium sulphate before delivery maintain magnesium sulfate for 6 hours is as effective as keeping it for 24 hours
Detailed Description:
The definitive treatment known for pre-eclampsia is the interruption of pregnancy While the definitive treatment is the pregnancy interruption management includes other measures that have proven effective including the administration of antihypertensive drugs for severe hypertension and that the use of anticonvulsant such as the magnesium sulfate
There are multiple studies that prove the effectiveness of magnesium sulfate to prevent eclampsia in patients with severe serious disorder Unfortunately these studies used the drug before birth and continue after birth Therefore the investigators can not conclude whether the administration just before pregnancy is sufficient to prevent seizure That is if the cure or definitive treatment of pre-eclampsia is the interruption did not seem necessary to justify the administration of anticonvulsant drugs after birth Obvious post delivery management sulfate arises from the large number of postpartum eclampsia reported in many studies It is unknown if the administration of magnesium sulfate for a minimum period not yet determined before birth and delivery requires even keep the drug after discontinuation
For all these reasons the investigators propose the following A randomized trial where all those patients who received magnesium sulfate for less that 8 hours before birth will be randomized to two groups of study 1- Continue magnesium sulfate for 24 hours and 2-Continue magnesium sulfate for 6 hours postpartum
There are multiple studies that prove the effectiveness of magnesium sulfate to prevent eclampsia in patients with severe serious disorder Unfortunately these studies used the drug before birth and continue after birth Therefore the investigators can not conclude whether the administration just before pregnancy is sufficient to prevent seizure That is if the cure or definitive treatment of pre-eclampsia is the interruption did not seem necessary to justify the administration of anticonvulsant drugs after birth Obvious post delivery management sulfate arises from the large number of postpartum eclampsia reported in many studies It is unknown if the administration of magnesium sulfate for a minimum period not yet determined before birth and delivery requires even keep the drug after discontinuation
For all these reasons the investigators propose the following A randomized trial where all those patients who received magnesium sulfate for less that 8 hours before birth will be randomized to two groups of study 1- Continue magnesium sulfate for 24 hours and 2-Continue magnesium sulfate for 6 hours postpartum
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None