A study to compare the administration of Magnesium Sulphate by the Intramuscular route and the Intravenous route via a special Springfusor pump and to compare the efficacy and side effects of the same.

Treatment approaches for pre eclampsia in low resource settinga

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000118

Enrollment

300

Registered

2008-07-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Intravenous administration of Magnesium Sulphate via Springfusor pump: NA Control Intervention1: Intramuscular administration of Magnesium Sulphate As in Pritchard&#039

s regimen:

Eligibility

Inclusion criteria

Inclusion criteria: &#61551; Exhibit systolic blood pressure > 140mm Hg OR a diastolic pressure > 100 mm Hg &#61551; Exhibit proteinuria > 1+; &#61551; Have not given birth, or be 24h or less postpartum &#61551; Exhibit urine output >100 ml or more during the previous 4h or greater than 25 mL/h. &#61551; Agree to comply with study procedures &#61551; Be > 18 years of age &#61551; Give informed consent for study participation

Exclusion criteria

Exclusion criteria: &#61551; Eclamptic or seizing at the time of enrollment &#61551; Received magnesium sulfate therapy 24h prior to study enrollment

Design outcomes

Primary

Measure	Time frame
Primary outcomes- &#61548; Maternal morbidity â?? Respiratory depression (<16 respirations per minute) â?? Respiratory arrest â?? Pneumonia â?? Cardiac arrest â?? Coagulopathy â?? Renal or liver failure â?? Pulmonary edema â?? Cerebral Hemorrhage &#61548; Toxicity â?? Need for calcium gluconate â?? Stopped or reduced treatment due to toxicity â?? Stopped or reduced treatment due to side effects &#61548; Side Effects â?? Nausea or vomitting â?? Flushing of the skin â?? Drowsiness â?? Confusion â?? Muscle weakness â?? Pain and Abscesss &#61548; Use of maternal healthcare resources â?? Number of days in hospital â?? Admission to intensive care unit (ICU) â?? Ventilation â?? Dialysis â?? Staff time &#61548; Use of neonatal resources â?? Days in special care baby unit â?? Ventilation Timepoint:	—

Measure

Time frame

Primary outcomes- &#61548; Maternal morbidity â?? Respiratory depression (<16 respirations per minute) â?? Respiratory arrest â?? Pneumonia â?? Cardiac arrest â?? Coagulopathy â?? Renal or liver failure â?? Pulmonary edema â?? Cerebral Hemorrhage &#61548; Toxicity â?? Need for calcium gluconate â?? Stopped or reduced treatment due to toxicity â?? Stopped or reduced treatment due to side effects &#61548; Side Effects â?? Nausea or vomitting â?? Flushing of the skin â?? Drowsiness â?? Confusion â?? Muscle weakness â?? Pain and Abscesss &#61548; Use of maternal healthcare resources â?? Number of days in hospital â?? Admission to intensive care unit (ICU) â?? Ventilation â?? Dialysis â?? Staff time &#61548; Use of neonatal resources â?? Days in special care baby unit â?? Ventilation Timepoint:

—

Secondary

Measure	Time frame
NATimepoint:	—

Countries

India

Contacts

Public ContactAnnie Regi

annieregi@cmcvellore.ac.in04162283399

Outcome results