A Phase 2/3 interventional study of Magnesium Sulfate in Severe Pre-eclampsia With Postnatal Complication, sponsored by Complejo Hospitalario Dr. Arnulfo Arias Madrid. Completed at 3 sites in Panama. Open to female participants aged 14 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-01.
Sponsored by Complejo Hospitalario Dr. Arnulfo Arias Madrid · Phase 2/3, Interventional, and Treatment
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.
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.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's enrollment of 280 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Complejo Hospitalario Dr. Arnulfo Arias Madrid is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Severe hypertensive disorder receiving magnesium sulfate prophylaxis for less than 8 hours at birth.
Exclusion Criteria:
The woman received magnesium sulfate for 6 hours after delivery as prophylaxis to eclampsia.
Drug: Magnesium Sulfate
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
Also known as: anticonvulsivant
Seizure (Eclampsia)
Seizure during the first 72 hours post delivery
Time frame: 72 hours postpartum
Diuresis postpartum
volume of urine post delivey
Time frame: 72 hours postpartum
Persistent symptomatology
headache, epigastric pain, visual and auditory symptoms symptoms
Time frame: 24 hours postpartum
Plan to share: No
The record gives a start of Nov 2013, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Magnesium Sulfate
Complejo Hospitalario Dr. Arnulfo Arias Madrid