Magnesium Sulfate in Pregnancy and Postpartum

Severe Pre-eclampsia With Postnatal Complication Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317146
• Other study ID #: complejoh4
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 11, 2014
• Last updated: January 31, 2017
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Complejo Hospitalario Dr. Arnulfo Arias Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia
• Severe Pre-eclampsia With Postnatal Complication

Intervention

Drug:
• Magnesium Sulfate
Magnesium sulfate is the drug used as prophylaxis to eclampsia in women with severe preeclampsia

Locations

Country	Name	City	State
Panama	Hospital Jose Domingo de Obaldia	Chiriqui
Panama	Hospital Manuel Amador Guerrero	Colon
Panama	Complejo Hospitalario Caja de Seguro Social	Panamá

Sponsors (1)

Lead Sponsor	Collaborator
Complejo Hospitalario Dr. Arnulfo Arias Madrid

Country where clinical trial is conducted

Panama, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure (Eclampsia)	Seizure during the first 72 hours post delivery	72 hours postpartum
Secondary	Diuresis postpartum	volume of urine post delivey	72 hours postpartum
Secondary	Persistent symptomatology	headache, epigastric pain, visual and auditory symptoms symptoms	24 hours postpartum