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Magnesium Sulfate in Pregnancy and Postpartum (MAG-PP)

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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

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.

Condition or disease Intervention/treatment Phase
Severe Pre-eclampsia With Postnatal Complication Drug: Magnesium Sulfate Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Six Hours Postpartum
The woman received magnesium sulfate for 6 hours after delivery as prophylaxis to eclampsia.
Drug: Magnesium Sulfate
Magnesium sulfate is the drug used as prophylaxis to eclampsia in women with severe preeclampsia
Other Name: anticonvulsivant

Active Comparator: Twenty-four hours Postpartum
The woman received magnesium sulfate for 24 hours after delivery as prophylaxis to eclampsia.
Drug: Magnesium Sulfate
Magnesium sulfate is the drug used as prophylaxis to eclampsia in women with severe preeclampsia
Other Name: anticonvulsivant




Primary Outcome Measures :
  1. Seizure (Eclampsia) [ Time Frame: 72 hours postpartum ]
    Seizure during the first 72 hours post delivery


Secondary Outcome Measures :
  1. Diuresis postpartum [ Time Frame: 72 hours postpartum ]
    volume of urine post delivey

  2. Persistent symptomatology [ Time Frame: 24 hours postpartum ]
    headache, epigastric pain, visual and auditory symptoms symptoms



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Ages Eligible for Study:   14 Years to 44 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317146


Locations
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Panama
Hospital Jose Domingo de Obaldia
Chiriqui, Panama
Hospital Manuel Amador Guerrero
Colon, Panama
Complejo Hospitalario Caja de Seguro Social
Panamá, Panama
Sponsors and Collaborators
Complejo Hospitalario Dr. Arnulfo Arias Madrid
Investigators
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Principal Investigator: Roberto Lewis, MD Caja de seguro Social

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paulino Vigil-De Gracia, Co-Investigator, Complejo Hospitalario Dr. Arnulfo Arias Madrid
ClinicalTrials.gov Identifier: NCT02317146     History of Changes
Other Study ID Numbers: complejoh4
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents