| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aneeshsjirge@gmail.com].
- 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.
- 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. |