Hypertension, Pregnancy-InducedPhase 2ForBPNCT03556761
Furosemide for Accelerated Recovery of Blood Pressure Postpartum
A Phase 2 study testing Oral furosemide in people with Hypertension, Pregnancy-Induced, run by University of Pennsylvania at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Hypertension, Pregnancy-Induced
- What is being tested?
- Oral furosemide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 384 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2018to 5 Feb 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Hypertensive disorder of pregnancy diagnosed antepartum or intrapartum
- Gestational hypertension
- Pre-eclampsia with or without severe features
- Superimposed pre-eclampsia with or without severe features
- New diagnosis of HDP within 24 hours from delivery
- Postpartum, delivery ≥ 20 weeks estimated gestational age
- Age ≥18 years old
Who cannot join
- History of allergic reaction to furosemide
- High risk comorbidities for which treatment may be indicated or contraindicated: class C or higher diabetes mellitus, chronic kidney disease or baseline creatinine >1.2, cardiac disorders including cardiomyopathy, congenital heart disease, angina or coronary heart disease, rheumatic disease (lupus), sickle cell disease
- Baseline labs with K <3
- Use of furosemide or other diuretics antepartum or intrapartum
- Use of ototoxic agents including aminoglycosides (ie, Gentamicin for >1 dose), cephalosporins (ie Ancef >1 dose),
- Patient unstable for protocol per investigator's judgement
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
Read the detailed description
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.
- Conditions
- Hypertension, Pregnancy-Induced
- Being tested
- Oral furosemide, Placebo Oral Tablet
- Keywords
- Furosemide, Postpartum, Hypertension
- Medical subject headings
- Hypertension, Pregnancy-Induced, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral furosemideDrug
Furosemide (Lasix), 20 milligram, PO, PO, daily
Placebo Oral TabletDrug
Placebo, PO, daily
| Study group | Role | What they receive |
|---|---|---|
| Oral furosemide | Experimental | Oral furosemide 20 mg/day for a total of 5 consecutive doses. Receives: Drug: Oral furosemide |
| Placebo Oral Tablet | Placebo comparator | Placebo once per day for a total of 5 consecutive doses. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistently Elevated Blood Pressures 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.
Measured: 0-7 days postpartum
Time to Resolution
To compare the time (days) required to achieve a resolution of elevated blood pressure, adjusted for mode of delivery.
Measured: 0-14 days postpartum
Secondary outcomes (6)
Postpartum Readmission
Number of subjects with one or more readmission/ER visit that were hypertension related
Measured: 0-6 weeks postpartum
Number of Subjects Who Had Severe Hypertension Postpartum
Number of women who had severe hypertension (systolic blood pressure>160 millimeters of mercury or diastolic blood pressure>110 millimeters of mercury) postpartum
Measured: 0-6 weeks postpartum
Postpartum Length of Stay
Number of days postpartum participants stayed in the hospital
Measured: 0-6 weeks postpartum
Subjects With Complications During Hospitalization
Subjects with complications during hospitalization related to hypertensive disorders of pregnancy.
Measured: 0-6 weeks postpartum
Number of Subjects Experiencing One or More Adverse Effects
Number of subjects experiencing one or more adverse effects secondary to furosemide
Measured: 0-6 weeks postpartum
Number of Subjects That Required for Additional Antihypertensives
Number of subjects that required additional hypertensive medication after discharge
Measured: 0 to 6 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start20 Jun 2018
- Primary completion4 Dec 2019
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, Pregnancy-InducedStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, randomized, placebo control design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Levine, University of Pennsylvania
- Investigators
- Lisa Levine, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556761
- Sponsor's protocol ID
- 829444
- Acronym
- ForBP
- Status last verified
- Aug 2020
- First submitted
- 1 Jun 2018
- Last updated
- 10 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33550824
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Furosemide for Accelerated Recovery of Blood Pressure Postpartum
- ClinicalTrials.gov ID
- NCT03556761
- Acronym / sponsor ID
- ForBP / 829444
- Conditions
- Hypertension, Pregnancy-Induced
- Keywords
- Furosemide, Postpartum, Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Posted 10 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, randomized, placebo control design
| Arm | Type | Receives |
|---|---|---|
| Oral furosemide | Experimental | Drug: Oral furosemideOral furosemide 20 mg/day for a total of 5 consecutive doses. |
| Placebo Oral Tablet | Placebo comparator | Drug: Placebo Oral TabletPlacebo once per day for a total of 5 consecutive doses. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Hypertensive disorder of pregnancy diagnosed antepartum or intrapartum
- Gestational hypertension
- Pre-eclampsia with or without severe features
- Superimposed pre-eclampsia with or without severe features
- New diagnosis of HDP within 24 hours from delivery
Key exclusion criteria (6 listed)
- History of allergic reaction to furosemide
- High risk comorbidities for which treatment may be indicated or contraindicated: class C or higher diabetes mellitus, chronic kidney disease or baseline creatinine >1.2, cardiac disorders including cardiomyopathy, congenital heart disease, angina or coronary heart disease, rheumatic disease (lupus), sickle cell disease
- Baseline labs with K <3
- Use of furosemide or other diuretics antepartum or intrapartum
- Use of ototoxic agents including aminoglycosides (ie, Gentamicin for >1 dose), cephalosporins (ie Ancef >1 dose),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral furosemideFurosemide (Lasix), 20 milligram, PO, PO, daily | Drug | Oral furosemide |
| Placebo Oral TabletPlacebo, PO, daily | Drug | Placebo Oral Tablet |
Primary outcome
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: 0-14 days postpartum
To compare the time (days) required to achieve a resolution of elevated blood pressure, adjusted for mode of delivery.
6 secondary outcomes
Postpartum Readmission
Time frame: 0-6 weeks postpartum
Number of Subjects Who Had Severe Hypertension Postpartum
Time frame: 0-6 weeks postpartum
Postpartum Length of Stay
Time frame: 0-6 weeks postpartum
Subjects With Complications During Hospitalization
Time frame: 0-6 weeks postpartum
Number of Subjects Experiencing One or More Adverse Effects
Time frame: 0-6 weeks postpartum
Number of Subjects That Required for Additional Antihypertensives
Time frame: 0 to 6 weeks post-partum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33550824Lopes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Levine, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral furosemide in people with Hypertension, Pregnancy-Induced, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistently Elevated Blood Pressures 7 Days Postpartum (time frame: 0-7 days postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03556761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.