Magnesium Sulfate in Pregnancy and Postpartum

NCT ID: NCT02317146

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-12-31

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.

Conditions

Severe Pre-eclampsia With Postnatal Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Six Hours Postpartum

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

Group Type: EXPERIMENTAL

Magnesium Sulfate

Intervention Type: DRUG

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

Twenty-four hours Postpartum

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

Group Type: ACTIVE_COMPARATOR

Magnesium Sulfate

Intervention Type: DRUG

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

Interventions

Magnesium Sulfate

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

Intervention Type: DRUG

Other Intervention Names

anticonvulsivant

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Complejo Hospitalario Dr. Arnulfo Arias Madrid

OTHER

Sponsor Role: lead

Responsible Party

Paulino Vigil-De Gracia

Co-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

Caja de seguro Social

Locations

Hospital Jose Domingo de Obaldia

Chiriquí, Chiriquí Province, Panama

Hospital Manuel Amador Guerrero

Colón, Provincia de Colón, Panama

Complejo Hospitalario Caja de Seguro Social

Panama City, Provincia de Panamá, Panama

Countries

Panama

References

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.

Reference Type: BACKGROUND

PMID: 12057549 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9790377 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12540643 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37815037 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28738788 (View on PubMed)

Other Identifiers

complejoh4

Identifier Type: -

Identifier Source: org_study_id