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Clinical Trials/NCT02317146
NCT02317146CompletedPhase 2

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

Complejo Hospitalario Dr. Arnulfo Arias Madrid3 sites in 1 country280 target enrollmentStarted: November 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
280
Locations
3
Primary Endpoint
Seizure (Eclampsia)

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
14 Years to 44 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Six Hours Postpartum

Experimental

The woman received magnesium sulfate for 6 hours after delivery as prophylaxis to eclampsia.

Intervention: Magnesium Sulfate (Drug)

Twenty-four hours Postpartum

Active Comparator

The woman received magnesium sulfate for 24 hours after delivery as prophylaxis to eclampsia.

Intervention: Magnesium Sulfate (Drug)

Outcomes

Primary Outcomes

Seizure (Eclampsia)

Time Frame: 72 hours postpartum

Seizure during the first 72 hours post delivery

Secondary Outcomes

  • Diuresis postpartum(72 hours postpartum)
  • Persistent symptomatology(24 hours postpartum)

Investigators

Sponsor
Complejo Hospitalario Dr. Arnulfo Arias Madrid
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Paulino Vigil-De Gracia

Co-Investigator

Complejo Hospitalario Dr. Arnulfo Arias Madrid

Study Sites (3)

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