HypertensionPhase 2NCT02450773
Prevention of Severe Postpartum Hypertension
A Phase 2 study testing Furosemide and Potassium chloride in people with Hypertension, run by Indiana University at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether postpartum administration of furosemide to women with antepartum hypertensive disorders (gestational hypertension, preeclampsia) or elevated blood pressure in the first 24 hours following delivery reduces severe postpartum hypertension. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Furosemide and Potassium chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2015to May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women > 18 years of age or emancipated minors
- Women undergoing vaginal or cesarean delivery at > 23 weeks gestation with:
- Antepartum diagnosis of gestational hypertension
- Antepartum diagnosis of preeclampsia
- Antepartum diagnosis of preeclampsia with severe features
- Mild hypertension (<150/100) in first 24 hours following delivery
Who cannot join
- Chronic hypertension
- Allergy to furosemide
- Pre-existing hypokalemia (serum K < 3.0 meq/L)
- Chronic kidney disease
- Serum Cr > 1.1
- Inability to obtain informed consent
- Pre-existing diuretic use
- Oliguria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University School of Medicine
Indianapolis, Indiana
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Furosemide for Prevention of Severe Postpartum Hypertension: a Randomized Controlled Trial
The purpose of this study is to determine whether postpartum administration of furosemide to women with antepartum hypertensive disorders (gestational hypertension, preeclampsia) or elevated blood pressure in the first 24 hours following delivery reduces severe postpartum hypertension.
- Conditions
- Hypertension
- Being tested
- Furosemide, Potassium chloride, Placebo #1, Placebo #2
- Keywords
- postpartum, preeclampsia, gestational hypertension
- Medical subject headings
- Hypertension, Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
Also called Lasix
40 mg furosemide on postpartum day 1-6
Potassium chlorideDrug
Also called KCl
20 meq potassium chloride on postpartum day 1-6
Placebo #1Drug
Placebo (for furosemide)
Placebo #2Drug
Placebo (for KCl)
| Study group | Role | What they receive |
|---|---|---|
| Furosemide/Potassium chloride | Experimental | 40 mg furosemide; 20 meq potassium chloride Receives: Drug: Furosemide; Drug: Potassium chloride |
| Placebo | Placebo comparator | Placebo #1, Placebo #2 Receives: Drug: Placebo #1; Drug: Placebo #2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite maternal morbidity
Requiring antihypertensive medication at discharge, readmission for blood pressure, end-organ damage from hypertension
Measured: 0-6 weeks following delivery
Secondary outcomes (5)
Adverse events associated with furosemide
Hypokalemia
Measured: 0-6 weeks following delivery
Adverse events associated with furosemide
hyperglycemia
Measured: 0-6 weeks following delivery
Adverse events associated with furosemide
oliguria
Measured: 0-6 weeks following delivery
Adverse events associated with furosemide
hypotension
Measured: 0-6 weeks following delivery
Adverse events associated with furosemide
elevated serum creatinine
Measured: 0-6 weeks following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Haas, Indiana University
- Investigators
- Methodius G Tuuli, MD, MPH, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450773
- Sponsor's protocol ID
- 201501157
- Status last verified
- May 2023
- First submitted
- 11 May 2015
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Furosemide for Prevention of Severe Postpartum Hypertension: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02450773
- Acronym / sponsor ID
- 201501157
- Conditions
- Hypertension
- Keywords
- postpartum, preeclampsia, gestational hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether postpartum administration of furosemide to women with antepartum hypertensive disorders (gestational hypertension, preeclampsia) or elevated blood pressure in the first 24 hours following delivery reduces severe postpartum hypertension.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Furosemide/Potassium chloride | Experimental | Drug: Furosemide, Drug: Potassium chloride40 mg furosemide; 20 meq potassium chloride |
| Placebo | Placebo comparator | Drug: Placebo #1, Drug: Placebo #2Placebo #1, Placebo #2 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Women > 18 years of age or emancipated minors
- Antepartum diagnosis of gestational hypertension
- Antepartum diagnosis of preeclampsia
- Antepartum diagnosis of preeclampsia with severe features
- Mild hypertension (<150/100) in first 24 hours following delivery
Key exclusion criteria (8 listed)
- Chronic hypertension
- Allergy to furosemide
- Pre-existing hypokalemia (serum K < 3.0 meq/L)
- Chronic kidney disease
- Serum Cr > 1.1
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 |
|---|---|---|
| FurosemideAlso: Lasix40 mg furosemide on postpartum day 1-6 | Drug | Furosemide/Potassium chloride |
| Potassium chlorideAlso: KCl20 meq potassium chloride on postpartum day 1-6 | Drug | Furosemide/Potassium chloride |
| Placebo #1Placebo (for furosemide) | Drug | Placebo |
| Placebo #2Placebo (for KCl) | Drug | Placebo |
Primary outcome
Composite maternal morbidity
Time frame: 0-6 weeks following delivery
Requiring antihypertensive medication at discharge, readmission for blood pressure, end-organ damage from hypertension
5 secondary outcomes
Adverse events associated with furosemide
Time frame: 0-6 weeks following delivery
Adverse events associated with furosemide
Time frame: 0-6 weeks following delivery
Adverse events associated with furosemide
Time frame: 0-6 weeks following delivery
Adverse events associated with furosemide
Time frame: 0-6 weeks following delivery
Adverse events associated with furosemide
Time frame: 0-6 weeks following delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
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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.
Methodius G Tuuli, MD, MPH principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Furosemide and Potassium chloride in people with Hypertension, run by Indiana University at 2 sites 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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Composite maternal morbidity (time frame: 0-6 weeks following delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2023.