Magnesium Sulfate in Pregnancy and Postpartum (MAG-PP)
Primary Purpose
Severe Pre-eclampsia With Postnatal Complication
Status
Completed
Phase
Phase 2
Locations
Panama
Study Type
Interventional
Intervention
Magnesium Sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Severe Pre-eclampsia With Postnatal Complication
Eligibility Criteria
Inclusion Criteria:
Severe hypertensive disorder receiving magnesium sulfate prophylaxis for less than 8 hours at birth.
Exclusion Criteria:
- Complications such as: HELLP syndrome, renal failure, eclampsia, retinal detachment, cerebral edema, pulmonary edema, hypertensive encephalopathy.
Sites / Locations
- Hospital Jose Domingo de Obaldia
- Hospital Manuel Amador Guerrero
- Complejo Hospitalario Caja de Seguro Social
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Six Hours Postpartum
Twenty-four hours Postpartum
Arm Description
The woman received magnesium sulfate for 6 hours after delivery as prophylaxis to eclampsia.
The woman received magnesium sulfate for 24 hours after delivery as prophylaxis to eclampsia.
Outcomes
Primary Outcome Measures
Seizure (Eclampsia)
Seizure during the first 72 hours post delivery
Secondary Outcome Measures
Diuresis postpartum
volume of urine post delivey
Persistent symptomatology
headache, epigastric pain, visual and auditory symptoms symptoms
Full Information
NCT ID
NCT02317146
First Posted
December 11, 2014
Last Updated
January 31, 2017
Sponsor
Complejo Hospitalario Dr. Arnulfo Arias Madrid
1. Study Identification
Unique Protocol Identification Number
NCT02317146
Brief Title
Magnesium Sulfate in Pregnancy and Postpartum
Acronym
MAG-PP
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Complejo Hospitalario Dr. Arnulfo Arias Madrid
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 dose.The 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Pre-eclampsia With Postnatal Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Six Hours Postpartum
Arm Type
Experimental
Arm Description
The woman received magnesium sulfate for 6 hours after delivery as prophylaxis to eclampsia.
Arm Title
Twenty-four hours Postpartum
Arm Type
Active Comparator
Arm Description
The woman received magnesium sulfate for 24 hours after delivery as prophylaxis to eclampsia.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Other Intervention Name(s)
anticonvulsivant
Intervention Description
Magnesium sulfate is the drug used as prophylaxis to eclampsia in women with severe preeclampsia
Primary Outcome Measure Information:
Title
Seizure (Eclampsia)
Description
Seizure during the first 72 hours post delivery
Time Frame
72 hours postpartum
Secondary Outcome Measure Information:
Title
Diuresis postpartum
Description
volume of urine post delivey
Time Frame
72 hours postpartum
Title
Persistent symptomatology
Description
headache, epigastric pain, visual and auditory symptoms symptoms
Time Frame
24 hours postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Severe hypertensive disorder receiving magnesium sulfate prophylaxis for less than 8 hours at birth.
Exclusion Criteria:
Complications such as: HELLP syndrome, renal failure, eclampsia, retinal detachment, cerebral edema, pulmonary edema, hypertensive encephalopathy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Lewis, MD
Organizational Affiliation
Caja de seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Jose Domingo de Obaldia
City
Chiriqui
Country
Panama
Facility Name
Hospital Manuel Amador Guerrero
City
Colon
Country
Panama
Facility Name
Complejo Hospitalario Caja de Seguro Social
City
Panamá
Country
Panama
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12057549
Citation
Altman D, Carroli G, Duley L, Farrell B, Moodley J, Neilson J, Smith D; Magpie Trial Collaboration Group. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet. 2002 Jun 1;359(9321):1877-90. doi: 10.1016/s0140-6736(02)08778-0.
Results Reference
background
PubMed Identifier
9790377
Citation
Ascarelli MH, Johnson V, May WL, Martin RW, Martin JN Jr. Individually determined postpartum magnesium sulfate therapy with clinical parameters to safely and cost-effectively shorten treatment for pre-eclampsia. Am J Obstet Gynecol. 1998 Oct;179(4):952-6. doi: 10.1016/s0002-9378(98)70195-4.
Results Reference
background
PubMed Identifier
12540643
Citation
Belfort MA, Anthony J, Saade GR, Allen JC Jr; Nimodipine Study Group. A comparison of magnesium sulfate and nimodipine for the prevention of eclampsia. N Engl J Med. 2003 Jan 23;348(4):304-11. doi: 10.1056/NEJMoa021180.
Results Reference
background
PubMed Identifier
28738788
Citation
Vigil-De Gracia P, Ramirez R, Duran Y, Quintero A. Magnesium sulfate for 6 vs 24 hours post delivery in patients who received magnesium sulfate for less than 8 hours before birth: a randomized clinical trial. BMC Pregnancy Childbirth. 2017 Jul 24;17(1):241. doi: 10.1186/s12884-017-1424-3.
Results Reference
derived
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Magnesium Sulfate in Pregnancy and Postpartum
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