Magnesium Sulfate During the Postpartum in Women With Severe Preeclampsia (MAG-PIP)

• ClinicalTrials.gov Identifier: NCT02307201
• Recruitment Status: Completed
• First Posted: December 4, 2014
• Last Update Posted: February 1, 2017
• Sponsor: Complejo Hospitalario Dr. Arnulfo Arias Madrid
• Information provided by (Responsible Party): Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid

Study Description

Brief Summary:

There is no evidence that patients receiving magnesium sulfate before birth are required to maintain the drug for 24 hours. Therefore the investigators will have a randomized clinical study in patients with severe preeclampsia who have been treated with impregnation of magnesium sulphate and at least eight hours have received the drug before birth. If the patient agrees and signs the consent is randomized to: 1-receive sulfate for 24 hours postpartum as usual or, 2- not receiving the postpartum magnesium sulfate or other anticonvulsant drugs. This study can be conducted in 12 maternity latin america.

Condition or disease	Intervention/treatment	Phase
Post Partum Severe Preeclampsia	Drug: Magnesium Sulfate	Phase 2; Phase 3

  Show Detailed Description

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Magnesium Sulfate During the Postpartum in Women With Severe Preeclampsia Receiving Treatment for More Than 8 Hours Before Delivery. A Randomized Multicenter Clinical Trial .
• Study Start Date: December 2014
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Postpartum Magnesium sulfate; The patient will receive magnesium sulfate as usual for 24 hours postpartum	Drug: Magnesium Sulfate; The patient will receive magnesium sulfate for 24 hours postpartum; Other Name: No postpartum treatment
No Intervention: No postpartum treatment; The patient did not receive postpartum magnesium sulfate or other anticonvulsant during 24 hours postpartum

Outcome Measures

Primary Outcome Measures :

1. Eclampsia [ Time Frame: 24 hours postpartum ]
   Convulsion after delivery in any group (with magnesium sulfate or without magnesium sulfate), during 24 hours postpartum.

Secondary Outcome Measures :

1. Postpartum hemorrhage [ Time Frame: 24 hours postpartum ]
   Blood loss > 500 post vaginal delivery or > 800 cc post cesarean section, during 24 hours postpartum
2. Maternal respiratory distress [ Time Frame: 24 hours postpartum ]
   clinical respiratory distress,during 24 hours postpartum
3. Grams of magnesium sulfate before delivery [ Time Frame: 8 to 72 hours with magnesium sulfate before delivery ]
   Hours and grams of magnesium sulfate before delivery
4. Severe hypertension postpartum [ Time Frame: 72 hours postdelivery ]
   Diastolic Blood pressure > 110 mmHg and/or systolic blood pressure > 160 mmHg

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 44 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Severe preeclampsia or severe preeclampsia aggregated to chronic hypertension with > 24 weeks of gestation treated with 4-6 grams of magnesium sulfate for impregnation with a minimum of 8 hours continuous of magnesium sulfate before delivery
• The study begins to terminate pregnancy

Exclusion Criteria:

• HELLP syndrome
• Eclampsia
• Renal insufficiency
• Diabetes mellitus
• Disease of collagen
• Heart disease

Contacts and Locations

Locations

Dominican Republic

Hospital Materno Infantil san Lorezo de las Minas

Santo Domingo, Dominican Republic

Hospital Universitario Maternidad Nuestra señoa de Alta Gracia

Santo Domingo, Dominican Republic

Ecuador

Hospital Teodoro Maldonado De Guayaquil

Guayaquil, Ecuador

El Salvador

Hospital Primero de Mayo

San Salvador, El Salvador

Panama

Hospital Jose Domingo De Obaldia

Chiriqui, Panama, 507

Complejo Hospitalario Caja de Seguro Social

Panamá, Panama, 507

Hospital Santo Tomás

Panamá, Panama, 507

Peru

Hospital Regional de Cojamarca, Perú,

Cajamarca, Peru

Instituto Materno perinatal, Maternidad de Lima

Lima, Peru

Sponsors and Collaborators

Complejo Hospitalario Dr. Arnulfo Arias Madrid

Investigators

• Principal Investigator: Paulino Vigil De Gracia; Complejo Hospitalario Dr. Arnulfo Arias Madrid
• Study Chair: Jack Ludmir, MD; School of medicine, Pennsylvania Hospital. University de Pennsylvania. Philadelphia

More Information

Publications of Results:

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.

Other Publications:

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.

• Responsible Party: Paulino Vigil-De Gracia, MEDICAL DOCTOR, GYNECOLOGY AND OBSTETRIC, Complejo Hospitalario Dr. Arnulfo Arias Madrid
• ClinicalTrials.gov Identifier: NCT02307201 History of Changes
• Other Study ID Numbers: complejoh
• First Posted: December 4, 2014
• Last Update Posted: February 1, 2017
• Last Verified: January 2017

Additional relevant MeSH terms:

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications; Magnesium Sulfate; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Anti-Arrhythmia Agents; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Tocolytic Agents; Reproductive Control Agents