FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2012/04/002553 [Registered on: 09/04/2012] Trial Registered Retrospectively
Last Modified On: 05/04/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   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 
Scientific Title of Study   Randomized Controlled Trial Comparing Two Different Regimes of Magnesium Sulphate in Severe Pre-eclampsia: A Pilot Study 
Trial Acronym  PIPES Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anish Keepanasseril  
Designation  Assistant Professor 
Affiliation  JIPMER 
Address  Department of Obstetrics and Gynecology JIPMER Pondicherry

Pondicherry
PONDICHERRY
605005
India 
Phone  8903307141  
Fax    
Email  keepan_r@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Anish Keepanasseril  
Designation  Assistant Professor 
Affiliation  JIPMER 
Address  Department of Obstetrics and Gynecology JIPMER Pondicherry

Pondicherry
PONDICHERRY
605005
India 
Phone  8903307141  
Fax    
Email  keepan_r@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Anish Keepanasseril  
Designation  Assistant Professor 
Affiliation  JIPMER 
Address  Department of Obstetrics and Gynecology JIPMER Pondicherry

Pondicherry
PONDICHERRY
605005
India 
Phone  8903307141  
Fax    
Email  keepan_r@yahoo.com  
 
Source of Monetary or Material Support  
JIPMER, Pondicherry 
 
Primary Sponsor  
Name  JIPMER  
Address  Dhanvanthri Nagar Pondicherry,605006 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anish Keepanasseril  Department of Obstetric and Gynecology  JIPMER Pondicherry
Pondicherry
PONDICHERRY 		 8903307141

keepan_r@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee (Human Studies), JIPMER, Pondicherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O141||Severe pre-eclampsia, Women with Severe Pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Magnesium Sulphate  •Group B: Loading Dose Only Regime oOnly 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; with no further doses of magnesium sulphate.  
Intervention  Magnesium Sulphate  •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 every four hours in alternate buttocks and it will be continued till 24 hours postpartum. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  •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
 
 
ExclusionCriteria 
Details  o Multiple Pregnancy
o Platelet count < 50,000/mm3
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.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Development of Eclampsia defined as new-onset grand mal seizures in a woman with preeclampsia  Within 48 hours postpartum 
 
Secondary Outcome  
Outcome  TimePoints 
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
 		 Within 48 hours postpartum 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "402"
Final Enrollment numbers achieved (India)="402" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2012 
Date of Study Completion (India) 31/03/2013 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Prophylactic magnesium sulphate in prevention of eclampsia in women with severe preeclampsia: randomised controlled trial (PIPES trial). Keepanasseril A, Maurya DK, Manikandan K, Suriya J Y, Habeebullah S, Raghavan SS. J Obstet Gynaecol. 2018 Apr;38(3):305-309. doi: 10.1080/01443615.2017.1351931.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Use of magnesium sulphate for the prevention of eclampsia, popularized by the Magpie trial, has been able to decrease the mortality and morbidity of women with pre-eclampsia. Experience using the shorter regimes for seizure prevention has been reported in women with eclampsia; however use for seizure prophylaxis in preeclampsia is limited world literature. There are no such studies reported from Indian subcontinent. So we plan to conduct to conduct a randomized control study comparing the commonly used regimes for seizure prophylaxis. We plan this study with the hypotheisis that  "Parenteral loading dose only regime is equally effective and more safe than the conventional low dose  regime of magnesium sulphate  for the prevention of eclampsia in women with sever preeclampsia".

 . 
 
Close