Severe Pre-eclampsia With Postnatal ComplicationPhase 2/3MAG-PPNCT02317146

Magnesium Sulfate in Pregnancy and Postpartum

A Phase 2/3 study testing Magnesium Sulfate in people with Severe Pre-eclampsia With Postnatal Complication, run by Complejo Hospitalario Dr. Arnulfo Arias Madrid at 3 sites in Panama.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 14 to 44 years, women onlyHealthy volunteers can take part
Conditions the study is for: Severe Pre-eclampsia With Postnatal Complication
What is being tested?: Magnesium Sulfate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 280 participants
Where: 3 sitesPanama
Study dates: Nov 2013to Dec 2016
Phase: Phase 2/3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 to 44 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

Severe hypertensive disorder receiving magnesium sulfate prophylaxis for less than 8 hours at birth.

Who cannot join

Complications such as: HELLP syndrome, renal failure, eclampsia, retinal detachment, cerebral edema, pulmonary edema, hypertensive encephalopathy.

Trial locations and contacts

3 sites in 1 country.

Panama3 sites

Hospital Jose Domingo de Obaldia
Chiriquí, Chiriquí Province
Hospital Manuel Amador Guerrero
Colón, Provincia de Colón
Complejo Hospitalario Caja de Seguro Social
Panama City, Provincia de Panamá

Other trials in Panama

About this study

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

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.

Read the 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.

Conditions: Severe Pre-eclampsia With Postnatal Complication
Being tested: Magnesium Sulfate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Magnesium SulfateDrug
Also called anticonvulsivant
Magnesium sulfate is the drug used as prophylaxis to eclampsia in women with severe preeclampsia

Study groups in NCT02317146
Study group	Role	What they receive
Six Hours Postpartum	Experimental	The woman received magnesium sulfate for 6 hours after delivery as prophylaxis to eclampsia. Receives: Drug: Magnesium Sulfate
Twenty-four hours Postpartum	Active comparator	The woman received magnesium sulfate for 24 hours after delivery as prophylaxis to eclampsia. Receives: Drug: Magnesium Sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

Seizure (Eclampsia)
Seizure during the first 72 hours post delivery
Measured: 72 hours postpartum

Secondary outcomes (2)

Diuresis postpartum
volume of urine post delivey
Measured: 72 hours postpartum
Persistent symptomatology
headache, epigastric pain, visual and auditory symptoms symptoms
Measured: 24 hours postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Dec 2016

First posted15 Dec 2014 (estimated)
Study startNov 2013
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Severe Pre-eclampsia With Postnatal ComplicationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 280 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02317146
Sponsor's protocol ID: complejoh4
Acronym: MAG-PP
Status last verified: Jan 2017
First submitted: 11 Dec 2014
Last updated: 1 Feb 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

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. doi: 10.1016/s0140-6736(02)08778-0.
PubMed 12057549
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.
PubMed 9790377
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.
PubMed 12540643
Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.
PubMed 37815037
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.
PubMed 28738788