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Trial record 2 of 8 for:    severe preeclampsia AND eclampsia | Panama

Magnesium Sulfate in Pregnancy and Postpartum (MAG-PP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02317146
Recruitment Status : Completed
First Posted : December 15, 2014
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid

Tracking Information
First Submitted Date  ICMJE December 11, 2014
First Posted Date  ICMJE December 15, 2014
Last Update Posted Date February 1, 2017
Study Start Date  ICMJE November 2013
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2014)
Seizure (Eclampsia) [ Time Frame: 72 hours postpartum ]
Seizure during the first 72 hours post delivery
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02317146 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2014)
  • Diuresis postpartum [ Time Frame: 72 hours postpartum ]
    volume of urine post delivey
  • Persistent symptomatology [ Time Frame: 24 hours postpartum ]
    headache, epigastric pain, visual and auditory symptoms symptoms
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Magnesium Sulfate in Pregnancy and Postpartum
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Severe Pre-eclampsia With Postnatal Complication
Intervention  ICMJE Drug: Magnesium Sulfate
Magnesium sulfate is the drug used as prophylaxis to eclampsia in women with severe preeclampsia
Other Name: anticonvulsivant
Study Arms  ICMJE
  • Experimental: Six Hours Postpartum
    The woman received magnesium sulfate for 6 hours after delivery as prophylaxis to eclampsia.
    Intervention: Drug: Magnesium Sulfate
  • Active Comparator: Twenty-four hours Postpartum
    The woman received magnesium sulfate for 24 hours after delivery as prophylaxis to eclampsia.
    Intervention: Drug: Magnesium Sulfate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2014)
280
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 14 Years to 44 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02317146
Other Study ID Numbers  ICMJE complejoh4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid
Study Sponsor  ICMJE Complejo Hospitalario Dr. Arnulfo Arias Madrid
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roberto Lewis, MD Caja de seguro Social
PRS Account Complejo Hospitalario Dr. Arnulfo Arias Madrid
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP