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The trial will test the equivalence of a repeat bolus protocol of magnesium sulfate administered by the Springfusor® controlled pump to a continuous intravenous regimen. The goal of this pharmacokinetic study is to assess the pharmacological equivalence of the serum magnesium sulfate concentrations obtained in the treatment of severe preeclampsia with the continuous intravenous and Springfusor repeat bolus regimens. The study will also document the clinical outcomes, efficacy and acceptability of each treatment for patients and staff.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV | Active Comparator | Women randomized into this treatment group will receive magnesium sulfate via an IV loading dose administered manually by study staff and an IV maintenance regimen. |
|
| Springfusor | Experimental | Women randomized into this treatment group will receive magnesium sulfate via IV infusion (with the Springfusor® pump). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Springfusor infusion pump | Device |
| ||
| IV administration |
| Measure | Description | Time Frame |
|---|---|---|
| Magnesium concentration | Blood draw times will be structured so as to perform a robust population PK analysis. Time zero is the end of the bolus administration. In the Springfusor arm, samples will be collected at the following times: 00:00, 00:20; 00:40; 1:20; 2:00; 2:20; 3:00; 4:40; 5:20; 6:00; 6:20; 7:00; 8:00; 9:40; 10:00; 10:40; 12:00. In the IV arm, samples will be collected at the following times: 0:00; 00:20; 00:40;1:00; 1:20; 1:40; 2:20; 3:00; 3:40; 4:20; 5:20; 6:40; 8:00; 9:20; 10:40 and 12:00. | 00:00, 00:20; 00:40; 1:20; 2:20; 3:00; 4:40; 5:20; 6:00; 6:20; 7:00; 8:00; 9:40; 10:00; 10:40; 12:00 |
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Inclusion Criteria:
Exhibit systolic blood pressure > 160mm Hg OR a diastolic pressure > 110 mm Hg (at two times over 30 minutes) (A single higher pressure could be accepted if the clinical team felt that magnesium sulfate therapy should be initiated without waiting 30 minutes).
Exhibit proteinuria > 1+; Have not given birth, or be <24h postpartum Be assessed by enrolling physician to benefit from magnesium sulfate therapy Agree to comply with study procedures Be > 18 years of age Give informed consent for study participation
Exclusion Criteria:
Eclamptic or seizing at the time of enrollment Received magnesium sulfate therapy 24h prior to study enrollment Known serum creatinine >1.2 mg/dL. (Subject may be enrolled prior to knowledge of serum creatinine but would be withdrawn if >1.2 mg/dL in order to have a proper dose adjustment.
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| Name | Affiliation | Role |
|---|---|---|
| Hillary Bracken, PhD | Gynuity Health Projects | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shatby Maternity Hospital | Alexandria | Egypt | ||||
| El Galaa Teaching Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 29976161 | Derived | Easterling T, Hebert M, Bracken H, Darwish E, Ramadan MC, Shaarawy S, Charles D, Abdel-Aziz T, Nasr AS, Safwal SM, Winikoff B. A randomized trial comparing the pharmacology of magnesium sulfate when used to treat severe preeclampsia with serial intravenous boluses versus a continuous intravenous infusion. BMC Pregnancy Childbirth. 2018 Jul 6;18(1):290. doi: 10.1186/s12884-018-1919-6. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 16, 2016 | |
| Reset | Jan 11, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 16, 2016 | Jan 11, 2017 |
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D009934 | Organization and Administration |
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D006298 | Health Services Administration |
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
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|
| Magnesium Sulfate | Drug |
|
| Cairo |
| 11511 |
| Egypt |
| D013464 |
| Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |