CTRI

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CTRI Number

CTRI/2025/03/082251 [Registered on: 12/03/2025] Trial Registered Prospectively

Last Modified On:

13/02/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Preventive

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

24 hours versus 6 hours post partum magnesium sulphate therapy

Scientific Title of Study

Traditional (24 hours) versus Abbreviated (6 hours) post partum magnesium sulphate therapy in patients with pre eclampsia with severe features: A Randomized Controlled Trial

Trial Acronym

Post partum MgSO4 therapy

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	DR SHAHANA SHERIN PP
Designation	JUNIOR RESIDENT
Affiliation	ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR
Address	ROOM NO 3085 THIRD FLOOR DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY MEDICAL COLLEGE BUILDING AIIMS JODHPUR ROOM NO 3085 THIRD FLOOR DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY MEDICAL COLLEGE BUILDING AIIMS JODHPUR Jodhpur RAJASTHAN 342001 India
Phone	9074264312
Fax
Email	sherinsheikh1313@gmail.com

Details of Contact Person
Scientific Query

Name	DR MANISHA JHIRWAL
Designation	ASSOCIATE PROFESSOR
Affiliation	ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR
Address	ROOM NO 3085 THIRD FLOOR DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY MEDICAL COLLEGE BUILDING AIIMS JODHPUR ROOM NO 3085 THIRD FLOOR DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY MEDICAL COLLEGE BUILDING AIIMS JODHPUR Jodhpur RAJASTHAN 342001 India
Phone	7042657811
Fax
Email	jhirwalm@aiimsjodhpur.edu.in

Details of Contact Person
Public Query

Name	DR SHAHANA SHERIN PP
Designation	JUNIOR RESIDENT
Affiliation	ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR
Address	ROOM NO 3085 THIRD FLOOR DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY MEDICAL COLLEGE BUILDING AIIMS JODHPUR ROOM NO 3085 THIRD FLOOR DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY MEDICAL COLLEGE BUILDING AIIMS JODHPUR RAJASTHAN 342001 India
Phone	9074264312
Fax
Email	sherinsheikh1313@gmail.com

Source of Monetary or Material Support

ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR INDUSTRIAL AREA BASNI RAJASTHAN INDIA PIN CODE 342001

Primary Sponsor

Name	ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR
Address	ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR INDUSTRIAL AREA BASNI RAJASTHAN INDIA PIN CODE 342001
Type of Sponsor	Research institution and hospital

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 SHAHANA SHERIN PP	ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR	LABOUR ROOM, DEPARTMENT OF OBSTETRICS AND GYNECOLOGY ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR Jodhpur RAJASTHAN	9074264312 sherinsheikh1313@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE(Clinical Trial) at AIIMS	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O141\|\|Severe pre-eclampsia,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Abbreviated post partum Magnesium sulphate therapy	Injection Magnesium sulphate infusion after delivery for 6 hours
Comparator Agent	Traditional post partum Magnesium Sulphate therapy	Injection Magnesium sulphate infusion after delivery for 24 hours

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Female
Details	Pregnant women diagnosed with pre-eclampsia with severe features at more than 20 weeks gestation Severe pre-eclampsia diagnosed when A patient have arterial pressures of 140/90 mmHg or higher at least twice separated by 4 hours with or without proteinuria equal to or greater than 0.3gms and have one or more of the following clinical criteria Severe hypertension (160/110 mmHg), if Neurological symptoms, epigastric pain, or Laboratory abnormalities Increase in creatinine, Thrombocytopenia, Elevation of liver enzymes, When the woman was known to have chronic hypertension and have one of the aforementioned criteria plus the presence of proteinuria equal to or greater than 0.3 gm, it is considered pre eclampsia with severe features

ExclusionCriteria

Details

1. Eclampsia before delivery,
2. HELLP syndrome,
3. Epilepsy
4. Pre-eclampsia with additional pathology
such as
Renal failure,
Acute pulmonary edema,
Decompensated diabetes mellitus,
Autoimmune diseases, or Hypertensive encephalopathy

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
Effectiveness of MgSo4	6 hrs Vs 24 hrs

Secondary Outcome

Outcome	TimePoints
OBJECTIVES: To assess a) Total time of magnesium sulphate infusion prior to birth b) Postpartum hemorrhage, c) Maternal respiratory distress d) Time to onset of ambulation post partum and breastfeeding start time e) Use of antihypertensives drugs in postpartum period f) Number of seizures in post partum period & time and duration of postpartum convulsion if any g) Feto - maternal outcome	72 hrs postpartum

Target Sample Size

Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

17/03/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary
Modification(s)

This study is a randomized, double blind, parallel group, active control trial comparing the benefits of MgSO4 infusion for traditional 24 hours postpartum versus abbreviated 6 hours postpartum in patients with pre eclampsia with severe features. The primary objective of the study is To assess MgSO4 infusion for 24 hours postpartum is as effective as 6 hours postpartum in patients with preeclampsia with severe features. The secondary objectives being to assess total time of magnesium sulphate infusion prior to birth, occurrence of seizures postpartum number of seizures in post partum period and time and duration of postpartum convulsion, postpartum bleeding, respiratory distress, time to onset of ambulation post partum and breastfeeding start time, use of postpartum antihypertensives, maternal death. Study population will be All Pregnant women diagnosed with pre-eclampsia with severe features at more than 20 weeks gestation willing to participate in study will be included in study. Patients refusing to give consent , patient with prior history of eclampsia before delivery, diagnosed with HELLP syndrome, known case of epilepsy, pre eclampsia with additional pathology such as renal failure, acute pulmonary edema, decompensated diabetes mellitus, autoimmune diseases, or hypertensive encephalopathy are excluded from the study. The expected outcome would be Abbreviated (6 hours) post partum magnesium sulphate therapy in patients with pre eclampsia with severe features is as effective as Traditional (24 hours) post partum magnesium sulphate therapy. Study population will be evaluated for 24 hours postpartum and total duration of study will be 2 years.