Magnesium Sulfate in Pregnancy and Postpartum (MAG-PP)

• ClinicalTrials.gov Identifier: NCT02317146
• Recruitment Status: Completed
• First Posted: December 15, 2014
• Last Update Posted: February 1, 2017
• Sponsor: Complejo Hospitalario Dr. Arnulfo Arias Madrid
• Information provided by (Responsible Party): Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Principal Investigator: Roberto Lewis, MD; Caja de seguro Social

More Information

Publications:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vigil-De Gracia P, Ramirez R, Durán 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.

• 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
• 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:

Eclampsia; Pre-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