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CTRI Number  CTRI/2025/07/091992 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 27/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A diuretic tablet for control of high blood pressure in women after delivery 
Scientific Title of Study   ORAL FUROSEMIDE FOR POSTPARTUM MANAGEMENT OF PATIENTS WITH PREGNANCY INDUCED HYPERTENSION 
Trial Acronym  OFFPPaM-PIH 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aneesh Jirge 
Designation  Postgraduate Resident 
Affiliation  SHRI DHARMASTHALA MANJUNATHESHWARA UNIVERSITY 
Address  Department of Obstetrics and Gynaecology SDM College of Medical Sciences and Hospital Manjushree Nagar Sattur Dharwad 580009

Dharwad
KARNATAKA
580009
India 
Phone  9591977475  
Fax    
Email  aneeshsjirge@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sahana Nagraj Naik D 
Designation  Professor Department of Obstetrics and Gynaecology 
Affiliation  SHRI DHARMASTHALA MANJUNATHESHWARA UNIVERSITY 
Address  Department of Obstetrics and Gynaecology SDM College of Medical Sciences and Hospital Manjushree Nagar Sattur Dharwad 580009

Dharwad
KARNATAKA
580009
India 
Phone  9886915751  
Fax    
Email  sahanasurpur@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aneesh Jirge 
Designation  Postgraduate Resident 
Affiliation  SHRI DHARMASTHALA MANJUNATHESHWARA UNIVERSITY 
Address  Department of Obstetrics and Gynaecology SDM College of Medical Sciences and Hospital Manjushree Nagar Sattur Dharwad 580009

Dharwad
KARNATAKA
580009
India 
Phone  9591977475  
Fax    
Email  aneeshsjirge@gmail.com  
 
Source of Monetary or Material Support  
SELF FUNDED Dr Aneesh Jirge Department of Obstetrics and Gynaecology SDM College of Medical Sciences and Hospital Manjushree Nagar Sattur Dharwad Karnataka India 580009 
SHRI DHARMASTHALA MANJUNATHESHWARA UNIVERSITY SDM College of Medical Sciences and Hospital Manjushree Nagar Sattur Dharwad Karnataka India 580009 
 
Primary Sponsor  
Name  Dr Aneesh Jirge 
Address  SDM College of Medical Science and Hospital Manjushree Nagar Sattur Dharwad 580009 
Type of Sponsor  Other [SELF] 
 
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 Aneesh Jirge  SDM College of Medical Sciences and Hospital   Department of Obstetrics and Gynaecology SDM College of Medical Science and Hospital Manjushree Nagar Sattur Dharwad 580009
Dharwad
KARNATAKA 
9591977475

aneeshsjirge@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDM College of Medical Sciences and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group participants with pregnancy induced hypertension will receive Amlodipine or Labetalol as per the hospital unit protocols  Following randomization by a computer-generated sequence the control group participants will receive Amlodipine or Labetalol as per the hospital unit protocols. BP and significant clinical features of the control group will be recorded on the first 5 days and 6-week postnatal care (PNC) visit  
Intervention  Oral Furosemide 20 mg OD for participants with pregnancy induced hypertension for the first 5 days of postpartum period   Following randomization by a computer-generated sequence the trial group participants will receive oral furosemide 20 mg OD for the first 5 days of postpartum period with the first dose given with 8 hours of delivery. Patients will receive appropriate antihypertensives as per the hospital unit protocols and oral furosemide will only be an add on drug. BP and significant clinical features of the trial group will be recorded on the first 5 days and 6-week postnatal care (PNC) visit 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  A. Women more than 18 years of age consenting to participate in the study
B. Women diagnosed with hypertensive disorder of pregnancy within the first day postpartum
 
 
ExclusionCriteria 
Details  A. Women less than 18 years of age
B. Women allergic to Furosemide
C. Chronic hypertensives with no superimposed Preeclampsia
D. Those who received diuretics before randomization
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
5 day course of postpartum oral furosemide will improve recovery by hastening BP normalisation in women with Pregnancy Induced Hypertension  BP and significant clinical features of the trial and control groups will be recorded on the first 5 days and 6-week postnatal care (PNC) visit 
 
Secondary Outcome  
Outcome  TimePoints 
1.Decreased need for additional antihypertensives.
2.Reduction in hypertension related postpartum readmissions.
3.Shortened hospital stay.
 
Upto 6 weeks after delivery 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   07/08/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aneeshsjirge@gmail.com].

  6. For how long will this data be available start date provided 26-07-2027 and end date provided 26-07-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

With Institutional Ethics Committee clearance and CTRI registration, 80 patients with the above-mentioned inclusion criteria will be recruited in the study.

Admission lists and in patient records will be screened daily to identify eligible patients. Women identified as having a hypertensive disorder of pregnancy will be invited to participate in the study. Protocol will be explained to all the patients and informed consent will be taken.

Relevant history, demographic data, eligibility, past and present medications, adverse event assessment and physical examination will be recorded.

Following randomization by a computer-generated sequence the trial group participants will receive oral furosemide 20 mg OD for the first 5 days of postpartum period with the first dose given with 8 hours of delivery. Patients will receive appropriate antihypertensives as per the hospital unit protocols and oral furosemide will only be an add on drug.  BP and significant clinical features of the trial and control groups will be recorded on the first 5 days and 6-week postnatal care (PNC) visit. Participants unable to visit the institution at 6 weeks postpartum will be encouraged to visit a primary health centre to obtain the BP readings.

Prompt treatment for elevated blood pressures will be initiated as soon as elevated blood pressures are recorded, and will not be delayed for study purposes including study drug administration. Medication used will be as per the treating clinician’s discretion.  

There is minimal risk to use of furosemide in the postpartum period. Furosemide is a commonly used drug in postpartum period and prior studies have not shown any adverse effects in this patient population. Committee that overlooks adverse drug reactions at the the hospital who are not investigators on the trial will be utilized to monitor adverse outcomes. All serious adverse effect will be recorded and reported to the institutional review board.

 
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