Role of Postpartum Furosemide in Recovery of Patients With Severe Preeclampsia
Efficacy of Postpartum Furosemide in Patients With Severe Preeclampsia: A Randomized Controlled Trial
This randomized controlled trial will compare oral furosemide with placebo for improving blood pressure control in women with severe preeclampsia after delivery. Participants will receive either 20 mg of furosemide or a placebo tablet once daily for 5 days, in addition to standard postpartum treatment for high blood pressure. Blood pressure, symptoms, adverse events, and the need for additional antihypertensive medication will be monitored for 7 days after delivery. The study will assess whether adding furosemide helps achieve better postpartum blood pressure control compared with placebo.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Severe preeclampsia can be associated with persistent or worsening high blood pressure after delivery. This randomized, double-blind, placebo-controlled trial will evaluate the efficacy of oral furosemide as an add-on treatment for postpartum blood pressure control in women with severe preeclampsia.
The study will be conducted in the Department of Obstetrics and Gynaecology, Lady Reading Hospital (MTI), Peshawar. A total of 434 women will be randomized into two groups, with 217 participants in each group. The intervention group will receive oral furosemide 20 mg once daily for 5 days after delivery, while the control group will receive a placebo tablet once daily for 5 days. Both groups will receive standard postpartum antihypertensive management, including monitoring and labetalol when required.
Participants will be followed from delivery through 7 days postpartum. Blood pressure will be monitored daily, including assessment of severe-range hypertension, symptoms, adverse events, and the need for additional antihypertensive medication. The primary assessment of efficacy will be based on achieving blood pressure below 140/90 mmHg on two readings 48 hours apart, without systolic blood pressure reaching 160 mmHg or higher or diastolic blood pressure reaching 110 mmHg or higher, and without requiring an increase in antihypertensive medication through 7 days postpartum.
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Dr Qandil Sattar, MBBS
- Phone Number: +923436144247
- Email: qantil.sattar@lrh.edu.pk
Study Contact Backup
- Name: Dr Syeda Wajeeha, MBBS
- Phone Number: +923436144247
- Email: wajeeha.syed@lrh.edu.pk
Study Locations
-
-
Khyber Pakhtunkhwa
-
Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
- Recruiting
- Lady Reading Hospital
-
Contact:
- Dr Syeda Wajeeha, MBBS
- Phone Number: +923436144247
- Email: wajeeha.syed@lrh.edu.pk
-
Contact:
- Dr Qandil Sattar, MBBS
- Phone Number: +923436144247
- Email: qandil.sattar@lrh.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women aged 18 to 45 years
- Any parity
- Gestational age >28 weeks based on LMP
- Severe preeclampsia as per the study operational definition
Exclusion Criteria:
History of underlying cardiac disease during pregnancy or postpartum
- Pre-existing renal dysfunction or serum creatinine >1.2 mg/dL on medical record
- Significant hypokalemia (K <3 mEq/L) before enrollment
- Known rheumatologic disease or advanced diabetes
- History of allergy to furosemide or prior use of diuretics before randomization
- History of thyroid disorders or other medical illnesses that may interfere with blood pressure management
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Furosemide Group
Participants will receive furosemide 20 mg tablet orally once daily for 5 days after delivery, in addition to standard postpartum antihypertensive treatment, including labetalol when required. |
Furosemide 20 mg tablet administered orally once daily for 5 days after delivery as an add-on to standard postpartum antihypertensive treatment. |
|
Placebo Comparator: Placebo Group
Participants will receive a placebo tablet orally once daily for 5 days after delivery, in addition to the same standard postpartum antihypertensive treatment provided to the furosemide group. |
Placebo tablet administered orally once daily for 5 days after delivery, in addition to standard postpartum antihypertensive treatment, including blood pressure monitoring and labetalol when required. |
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure
Time Frame: From delivery through 7 days postpartum
|
Proportion of participants achieving blood pressure below 140/90 mmHg on two readings taken 48 hours apart, with no systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg, and no need for an increase in antihypertensive medication from delivery through 7 days postpartum. |
From delivery through 7 days postpartum
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Dr Qandil Sattar, Lady Reading Hospital Peshawar
- Principal Investigator: Dr Syeda Wajeeha, Lady Reading Hospital Peshawar
Publications and helpful links
General Publications
- Veena P, Perivela L, Raghavan SS. Furosemide in postpartum management of severe preeclampsia: A randomized controlled trial. Hypertens Pregnancy. 2017 Feb;36(1):84-89. doi: 10.1080/10641955.2016.1239735. Epub 2016 Nov 11.
- Lopes Perdigao J, Lewey J, Hirshberg A, Koelper N, Srinivas SK, Elovitz MA, Levine LD. Furosemide for Accelerated Recovery of Blood Pressure Postpartum in women with a hypertensive disorder of pregnancy: A Randomized Controlled Trial. Hypertension. 2021 May 5;77(5):1517-1524. doi: 10.1161/HYPERTENSIONAHA.120.16133. Epub 2021 Feb 8.
- Pagan M, Ounprpaseuth ST, Ghahremani T, Doiron T, Magann EF. Furosemide for postpartum blood pressure control in patients with hypertensive disorders. Eur J Obstet Gynecol Reprod Biol X. 2023 May 3;18:100195. doi: 10.1016/j.eurox.2023.100195. eCollection 2023 Jun.
- Hup RJ, Paauw ND, Lely AT, Depmann M. Oral antihypertensive agents and diuretics in the management of hypertension in postpartum women: a systematic review and meta-analysis. BMJ Open. 2024 Dec 20;14(12):e086208. doi: 10.1136/bmjopen-2024-086208.
- Steele DW, Adam GP, Saldanha IJ, Kanaan G, Zahradnik ML, Danilack VA, Stuebe AM, Peahl AF, Chen KK, Balk EM. Management of Postpartum Hypertensive Disorders of Pregnancy [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2023 May. Report No.: AHRQ 23-EHC012Report No.: PCORI(R) 2023-SR-02. Available from http://www.ncbi.nlm.nih.gov/books/NBK592560/
- Keiseb J, Moodley J, Connolly CA. Comparison of the efficacy of continuous furosemide and low-dose dopamine infusion in preeclampsia/eclampsia-related oliguria in the immediate postpartum period. Hypertens Pregnancy. 2002;21(3):225-34. doi: 10.1081/PRG-120016787.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Pregnancy Complications
- Hypertension
- Pre-Eclampsia
- Hypertension, Pregnancy-Induced
- Sulfur Compounds
- Organic Chemicals
- Amides
- Aniline Compounds
- Amines
- Inorganic Chemicals
- Metals, Alkali
- Elements
- Metals, Light
- Metals
- Sulfonamides
- Sulfanilamides
- Sulfones
- Furosemide
- Potassium
Other Study ID Numbers
Other Study ID Numbers
- 48/LRH/MTI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The synopsis only states that participant information will be kept confidential and that access will be limited, with the ethics committee able to review the information when necessary.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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