Furosemide for Accelerated Recovery of Blood Pressure Postpartum (ForBP)
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|ClinicalTrials.gov Identifier: NCT03556761|
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : June 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypertension, Pregnancy-Induced||Drug: Oral furosemide Drug: Placebo Oral Tablet||Phase 2|
Hypertensive disorders of pregnancy are recognized causes of significant maternal/fetal morbidity and mortality, accounting for approximately 18% of maternal deaths worldwide. While significant research has been done on the evaluation and management of hypertension during pregnancy, studies of postpartum hypertension (PPHTN) are usually limited by their retrospective design and focus on inpatients in the immediate postpartum period (2-6 days), or patients who were readmitted due to complications related to hypertension. Few studies have investigated the incidence and proper management of hypertension in the postpartum period. Furthermore, in the United Kingdom, a review of maternal deaths determined that 10% were related to hypertensive disorders in pregnancy (HDP) in the postpartum period. Postpartum hypertension is also the cause of approximately 27% of readmissions to the hospital. These studies clearly show that PPHTN is associated with significant morbidity and that it is important to develop interventions that can reduce its effects.
In patients with HDP, postpartum blood pressure has been shown to decrease in the first 48 hours postpartum only to then increase in days 3-6 postpartum. This phenomenon is thought to be secondary to large fluid shifts, both secondary from fluid retention during the pregnant state as well as from fluids given intrapartum. Furthermore, large volumes of sodium are also mobilized into the intravascular compartment at this time. Given the latter, furosemide, a loop diuretic that mobilizes sodium and fluid excretion has been posed as a method to prevent severe range blood pressures and their associated maternal morbidity in the postpartum period.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||385 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double blind, randomized, placebo control design|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Study medication (furosemide) and placebo will be stored at room temperature at the University of Pennsylvania research pharmacy. Pharmacy will be responsible for labeling and randomizing the medications.|
|Official Title:||Furosemide for Accelerated Recovery of Blood Pressure Postpartum|
|Actual Study Start Date :||June 20, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: Oral furosemide
Oral furosemide 20 mg/day for a total of 5 consecutive doses.
Drug: Oral furosemide
Furosemide (Lasix), 20 milligram, PO, PO, daily
Placebo Comparator: Placebo Oral Tablet
Placebo once per day for a total of 5 consecutive doses.
Drug: Placebo Oral Tablet
Placebo, PO, daily
- Persistently elevated blood pressures 7 days postpartum [ Time Frame: 0-7 days postpartum ]To compare the rate of persistently elevated blood pressures (>140/90) in women that receive a five day furosemide course compared to those that receive placebo.
- Time to resolution [ Time Frame: 0-7 days postpartum ]To compare the time (days) required to achieve a resolution of elevated blood pressure.
- Postpartum readmission [ Time Frame: 0-6 weeks postpartum ]Number of readmission/ ER visit that is hypertension related
- Frequency of severe hypertension [ Time Frame: 0-6 weeks postpartum ]Frequency of severe hypertension (systolic blood pressure>160 millimeters of mercury or diastolic blood pressure>110 millimeters of mercury)
- Postpartum length of stay [ Time Frame: 0-6 weeks postpartum ]Postpartum length of stay
- Complications during hospitalization [ Time Frame: 0-6 weeks postpartum ]Composite of complications during hospitalization related to hypertensive disorders of pregnancy.
- Adverse effects [ Time Frame: 0-6 weeks postpartum ]Adverse effects secondary to furosemide
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556761
|Contact: Valerie M Riis, MSemail@example.com|
|Contact: Joana Perdigao, MD||Joana.LopesPerdigao@uphs.upenn.edu|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Valerie M Riis, MS 215-615-6047 firstname.lastname@example.org|
|Principal Investigator: Lisa Levine, MD|