Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT03556761
A randomized, double-blind, placebo-controlled single center investigation of furosemide's effect on postpartum blood pressure control in pregnancies affected by hypertensive disorders of pregnancy
Looking for future studies?
Notify Me18 year–55 year
Female
Interventional
Phase 2
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Furosemide (Lasix), 20 milligram, PO, PO, daily
Placebo, PO, daily
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 frame: 0-14 days postpartum
To compare the time (days) required to achieve a resolution of elevated blood pressure, adjusted for mode of delivery.
Time frame: 0-6 weeks postpartum
Number of subjects with one or more readmission/ER visit that were hypertension related
Time frame: 0-6 weeks postpartum
Number of women who had severe hypertension (systolic blood pressure>160 millimeters of mercury or diastolic blood pressure>110 millimeters of mercury) postpartum
Time frame: 0-6 weeks postpartum
Number of days postpartum participants stayed in the hospital
Time frame: 0-6 weeks postpartum
Subjects with complications during hospitalization related to hypertensive disorders of pregnancy.
Time frame: 0-6 weeks postpartum
Number of subjects experiencing one or more adverse effects secondary to furosemide
Time frame: 0 to 6 weeks post-partum
Number of subjects that required additional hypertensive medication after discharge
University of Pennsylvania
Other
Acronym: ForBP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05849103
Cardiovascular Diseases, Female Urogenital Diseases and Pregnancy Complications
Nashville, Tennessee, United States
View Trial DetailsNCT04752475
Cardiovascular Diseases, Female Urogenital Diseases and Pregnancy Complications
New York, United States
View Trial DetailsNCT03334149
Cardiovascular Diseases, Female Urogenital Diseases and Pregnancy Complications
Aylesbury, United Kingdom
View Trial DetailsNCT03873194
Cardiovascular Diseases, Female Urogenital Diseases and Pregnancy Complications
São Paulo, Brazil
View Trial Details