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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Six Hours Postpartum | Experimental | The woman received magnesium sulfate for 6 hours after delivery as prophylaxis to eclampsia. |
|
| Twenty-four hours Postpartum | Active Comparator | The woman received magnesium sulfate for 24 hours after delivery as prophylaxis to eclampsia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug | Magnesium sulfate is the drug used as prophylaxis to eclampsia in women with severe preeclampsia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seizure (Eclampsia) | Seizure during the first 72 hours post delivery | 72 hours postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Diuresis postpartum | volume of urine post delivey | 72 hours postpartum |
| Persistent symptomatology | headache, epigastric pain, visual and auditory symptoms symptoms |
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Inclusion Criteria:
Severe hypertensive disorder receiving magnesium sulfate prophylaxis for less than 8 hours at birth.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Lewis, MD | Caja de seguro Social | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Jose Domingo de Obaldia | Chiriquí | Chiriquí Province | Panama | |||
| Hospital Manuel Amador Guerrero |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12057549 | Background | 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. | |
| 9790377 | Background |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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|
| 24 hours postpartum |
| Colón |
| Provincia de Colón |
| Panama |
| Complejo Hospitalario Caja de Seguro Social | Panama City | Provincia de Panamá | Panama |
| 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. |
| 12540643 | Background | 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. |
| 37815037 | Derived | 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. |
| 28738788 | Derived | 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. |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |