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A Clinical trial to study two different dosage regimes (Dhaka regime and loading dose only regime) of the drug magnesium sulphate used to prevent the development of eclampsia in women with severe pre-eclampsia

Randomized Controlled Trial Comparing Two Different Regimes of Magnesium Sulphate in Severe Pre-eclampsia: A Pilot Study - PIPES Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/04/002553
Enrollment
400
Registered
2012-04-09
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

Health Condition 1: O141- Severe pre-eclampsia Health Condition 2: null- Women with Severe Pre-eclampsia

Interventions

Intervention1: Magnesium Sulphate: â?¢Group A: Dhaka Regime o loading dose of 10 gm of magnesium sulphate
4 gm as 20% given intravenously over 10- 15 minutes and 6gm as 50 % solution, 3gm intramuscularly in each buttock. A maintenance dose of 2.5 gm of magnesium sulphate will be given intramuscularly
4 gm as 20% given intravenously over 10- 15 minutes and 6gm as 50 % solution, 3gm intramuscularly in each buttock
with no further doses of magnesium sulphate.

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Any pregnant woman with Severe Pre- eclampsia as per the ACOG Criteria: o Systolic blood pressure of 160 mm Hg or higher or diastolic blood pressure of 110 mm Hg or higher on two occasions at least 6 hours apart. o Proteinuria of 5 gm or higher in a 24-hour urine specimen or 3+ or greater on two random urine samples collected at least 4 hours apart. o Oliguria of less than 500 ml in 24 hours. o Cerebral or visual disturbances o Pulmonary edema or cyanosis o Epigastric or right upper-quadrant pain o Impaired liver function o Thrombocytopenia o Fetal growth restriction

Exclusion criteria

Exclusion criteria: o Multiple Pregnancy o Platelet count o Plasma creatinine value >= 2mg/dl o Comatose patients o Deranged coagulation profile o Known case of myasthenia gravis o Known case of seizure disorder o Patients with Eclampsia (defined as presence of new-onset grand mal seizures in a woman with preeclampsia). o Hypersensitivity to Magnesium. o Women who have received have received magnesium sulphate therapy before being referred.

Design outcomes

Primary

MeasureTime frame
Development of Eclampsia defined as new-onset grand mal seizures in a woman with preeclampsiaTimepoint: Within 48 hours postpartum

Secondary

MeasureTime frame
Maternal Death o Serious Maternal Morbidity such Renal Failure, Liver Failure, Pulmonary Edema, Cerebral hemorrhage, Coagulopathy, Cardiac arrest o Complications of labor and delivery such as Placental Abruption, Incidence of Cesarean Section, Retained Placenta, Blood Transfusion o Side Effects due to magnesium sulphate such as Nausea or vomiting, abscess, Respiratory Depression oFetal Complications Still birth, APGAR Score At 5 minutes, Neonatal ICU admission, neonatal Loss Timepoint: Within 48 hours postpartum

Countries

India

Contacts

Public ContactAnish Keepanasseril

JIPMER

keepan_r@yahoo.com8903307141

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026