| CTRI Number |
CTRI/2025/10/095912 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of drug oral furosemide on post delivery blood pressure in women with Hypertensive Disorders in Pregnancy. |
|
Scientific Title of Study
|
Effect of oral furosemide on postpartum blood pressure in women with Hypertensive Disorders in Pregnancy: A Randomised Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maheshwari GK |
| Designation |
PG Resident MS obstetrics and Gynaecology |
| Affiliation |
Jawaharlal Nehru Medical College , KLE Belagavi |
| Address |
Jawaharlal Nehru Medical College ,KLE academy of higher education and research centre Nehru Nagar , Belagavi 590010
Jawaharlal Nehru Medical College ,KLE academy of higher education and research centre Nehru Nagar , Belagavi 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9886939395 |
| Fax |
|
| Email |
maheshwarigubbi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrutyunjaya B Bellad |
| Designation |
Professor Obstetrics and Gynaecology |
| Affiliation |
|
| Address |
Jawaharlal Nehru Medical College ,KLE academy of higher education and research centre Nehru Nagar , Belagavi 590010
Jawaharlal Nehru Medical College ,KLE academy of higher education and research centre Nehru Nagar , Belagavi 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9448124893 |
| Fax |
|
| Email |
belladmb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrutyunjaya B Bellad |
| Designation |
Professor Obstetrics and Gynaecology |
| Affiliation |
Jawaharlal Nehru Medical College , KLE Belagavi |
| Address |
Jawaharlal Nehru Medical College ,KLE academy of higher education and research centre Nehru Nagar , Belagavi 590010
Jawaharlal Nehru Medical College ,KLE academy of higher education and research centre Nehru Nagar , Belagavi 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9448124893 |
| Fax |
|
| Email |
belladmb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College ,KLE academy of higher education and research centre Nehru Nagar , Belagavi 590010
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Dr Maheshwari GK |
| Address |
Jawaharlal Nehru Medical College , KLE Belagavi 590010 |
| 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 Maheshwari GK |
KLEs Dr Prabhakar Kore Hospital and Medical Research Centre |
Department of Obstetrics and Gynaecology
Jawaharlal Nehru Medical College , KLEs Prabhakar Kore Hospital ,Belagavi 590010
Belgaum
KARNATAKA |
9886939395
maheshwarigubbi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral furosemide |
Single dose of 40mg oral furosemide is to be given 8hrs after delivery.
Assessment for symptoms,hospital course, bp trends,need for potential hospital visit is done after 72hours |
| Comparator Agent |
Placebo drug |
Patient will either get actual drug or placebo, placebo looks similar to the actual drug but don’t cause any effect on patient’s overall |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women diagnosed with Hypertensive Disorder of pregnancy including gestational hypertension preeclampsia with or without severe features
Hemodynamically stable patients who delivered a foetus of more than twenty week period of gestation |
|
| ExclusionCriteria |
| Details |
History of allergic reaction to furosemide
Hypotension
Hypokalaemia
Women who received diuretics before randomisation
High risk comorbidities for which treatment may be indicated like overt diabetes mellitus chronic kidney disease cardiac disorders of pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of persistent hypertension 72 hours postpartum or at the time of discharge |
72hours postpartum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of postpartum BP in severe range
Need for any additional anti Hypertensive medication postpartum
Postpartum length of stay
Postpartum readmission |
72 hours 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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
Persistent postpartum hypertension is a significant cause of maternal morbidity including heart failure and stroke.While postpartum hypertension can present following a normotensive pregnancy most postpartum hypertension complications are in women with persistent hypertension following a pregnancy complicated by preeclampsia or Hypertensive disorder in pregnancy.in women with Hypertensive Disorder in pregnancy, blood pressure decreases in first 48hours postpartum and then increases during day 3to 6 postpartum as a result of fluid retention and mobilisation of large volume of sodium into intravascular compartment.This change in fluid dynamics can affect blood pressure and hinder efficient blood pressure control during postpartum. Hypertensive Disorders in pregnancy include gestational hypertension preeclampsia and preeclampsia superimposed on chronic hypertension with or without severe features Gestational hypertension is defined as 2BP more than 140/90 mmhg at least 4hours apart with no protein urea and no other laboratory abnormalities Preeclampsia without severe features has additional requirement of proteinuria Preeclampsia with severe features is diagnosed after 2 BP readings of more than 160/110 mmhg at least 4 hours apart or any of the abnormal lab parameters Furosemide being loop diuretic acts on ascending loop of Henley in the kidneys to inhibit sodium and chloride absorption leading to increased urine output.This may be potential to reduce intravascular volume in postpartum period with fluid overload and assist with blood pressure control
|