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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dr Qandil Sattar, MBBS
- Número de teléfono: +923436144247
- Correo electrónico: qantil.sattar@lrh.edu.pk
Copia de seguridad de contactos de estudio
- Nombre: Dr Syeda Wajeeha, MBBS
- Número de teléfono: +923436144247
- Correo electrónico: wajeeha.syed@lrh.edu.pk
Ubicaciones de estudio
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Khyber Pakhtunkhwa
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Peshawar, Khyber Pakhtunkhwa, Pakistán, 25000
- Reclutamiento
- Lady Reading Hospital
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Contacto:
- Dr Syeda Wajeeha, MBBS
- Número de teléfono: +923436144247
- Correo electrónico: wajeeha.syed@lrh.edu.pk
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Contacto:
- Dr Qandil Sattar, MBBS
- Número de teléfono: +923436144247
- Correo electrónico: qandil.sattar@lrh.edu.pk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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. |
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Comparador de placebos: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Blood pressure
Periodo de tiempo: From delivery through 7 days postpartum
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dr Qandil Sattar, Lady Reading Hospital Peshawar
- Investigador principal: Dr Syeda Wajeeha, Lady Reading Hospital Peshawar
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Complicaciones del embarazo
- Hipertensión
- Preeclampsia
- Hipertensión, inducida por el embarazo
- Compuestos de azufre
- Químicos orgánicos
- Amidas
- Compuestos anilina
- Amina
- Químicos inorgánicos
- Metales, álcali
- Elementos
- Metales, luz
- Rieles
- Sulfonamidas
- Sulfanilamidas
- Sulfonas
- Furosemida
- Potasio
Otros números de identificación del estudio
- 48/LRH/MTI
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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