Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Treatment Approaches for Preeclampsia in Low-Resource Settings
Brief Summary: Preeclampsia is a condition unique to pregnancy characterized by the new onset of hypertension and proteinuria. Eclampsia, characterized by maternal seizures, is a serious complication increasing the risk of maternal and infant mortality and morbidity. Magnesium sulfate is the drug of choice for prevention and treating convulsions in severe preeclampsia and eclampsia.

Magnesium sulfate is administered parenterally by intramuscular (IM) or intravenous routes (IV). In general a loading dose of 4 to 5 grams of magnesium sulfate is administered intravenously followed by an IM injection every 4 hours or by a continuous IV infusion. The IV regimen achieves more stable serum levels of magnesium but requires the use of an infusion pump for safe delivery and has a greater potential for inadvertent overdose. Although magnesium sulfate has been demonstrated as a safe and effective drug for the treatment and prevention of severe preeclampsia and eclampsia, concerns about the safety of the drug remain. The IM dosing regimen, while potentially safer, requires repeated painful IM injections. These limitations in administration hinder the widespread use of magnesium sulfate despite its demonstrated benefits.

The goal of this research is to develop a system of care that avoids overdose and facilitates the use of magnesium sulfate for the treatment of preeclampsia. To this end, a primary objective of this research is to demonstrate the safety of a simple, inexpensive flow controlled pump system (Springfusor®). This randomized study will compare the administration of magnesium sulfate by the Springfusor® controlled pump with an IM regimen, the standard of care in most hospitals in India. The study will document the efficacy and acceptability of each treatment for patients and staff and compare the cost and time elements involved in providing each method.


Options:
A: Arm Label: 2; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: 1; Type: EXPERIMENTAL; Interventions: Device: SpringFusor Pump | Intervention Type: DEVICE; Name: SpringFusor Pump; Assigned to Arm(s): 1
B: Arm Label: Postpartum Magnesium sulfate; Type: EXPERIMENTAL; Interventions: Drug: Magnesium Sulfate | Arm Label: No postpartum treatment; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Magnesium Sulfate; Assigned to Arm(s): Postpartum Magnesium sulfate
C: Arm Label: MgSO4 4g load, 1g/hr infusion; Type: ACTIVE_COMPARATOR; Interventions: Drug: Magnesium sulfate 4g loading dose, 1g/hr infusion | Arm Label: MgSO4 6g load, 2g/hr infusion; Type: EXPERIMENTAL; Interventions: Drug: Magnesium sulfate 6g loading dose, 2g/hr infusion | Intervention Type: DRUG; Name: Magnesium sulfate 4g loading dose, 1g/hr infusion; Assigned to Arm(s): MgSO4 4g load, 1g/hr infusion | Intervention Type: DRUG; Name: Magnesium sulfate 6g loading dose, 2g/hr infusion; Assigned to Arm(s): MgSO4 6g load, 2g/hr infusion
D: Arm Label: Six Hours Postpartum; Type: EXPERIMENTAL; Interventions: Drug: Magnesium Sulfate | Arm Label: Twenty-four hours Postpartum; Type: ACTIVE_COMPARATOR; Interventions: Drug: Magnesium Sulfate | Intervention Type: DRUG; Name: Magnesium Sulfate; Assigned to Arm(s): Six Hours Postpartum, Twenty-four hours Postpartum

Answer: A