Skip to main content
OpenTrials
Completed

NCT Number: NCT02317146

Magnesium Sulfate in Pregnancy and 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

14 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Jose Domingo de Obaldia, Chiriquí, Chiriquí Province, Panama

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnesium sulfate

Drug

Magnesium sulfate is the drug used as prophylaxis to eclampsia in women with severe preeclampsia

Other names: anticonvulsivant

Primary outcomes

  1. Seizure (Eclampsia)

    Time frame: 72 hours postpartum

    Seizure during the first 72 hours post delivery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Complejo Hospitalario Dr. Arnulfo Arias Madrid

Other

Registry information

Official study 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

Acronym: MAG-PP

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 15, 2014
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.