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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02307201 |
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Date of registration:
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24/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Magnesium Sulfate During the Postpartum in Women With Severe Preeclampsia
MAG-PIP |
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Scientific title:
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Magnesium Sulfate During the Postpartum in Women With Severe Preeclampsia Receiving Treatment for More Than 8 Hours Before Delivery. A Randomized Multicenter Clinical Trial . |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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1114 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02307201 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Dominican Republic
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Ecuador
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El Salvador
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Guatemala
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Honduras
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Mexico
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Panama
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Paraguay
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Peru
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Uruguay
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Contacts
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Name:
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Jack Ludmir, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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School of medicine, Pennsylvania Hospital. University de Pennsylvania. Philadelphia |
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Name:
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Paulino Vigil De Gracia |
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Address:
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Telephone:
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Email:
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Affiliation:
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Complejo Hospitalario Dr. Arnulfo Arias Madrid |
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Key inclusion & exclusion criteria
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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
Age minimum:
14 Years
Age maximum:
44 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Post Partum Severe Preeclampsia
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Intervention(s)
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Drug: Magnesium Sulfate
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Primary Outcome(s)
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Eclampsia
[Time Frame: 24 hours postpartum]
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Secondary Outcome(s)
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Grams of magnesium sulfate before delivery
[Time Frame: 8 to 72 hours with magnesium sulfate before delivery]
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Postpartum hemorrhage
[Time Frame: 24 hours postpartum]
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Maternal respiratory distress
[Time Frame: 24 hours postpartum]
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Severe hypertension postpartum
[Time Frame: 72 hours postdelivery]
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Secondary ID(s)
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complejoh
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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