PreeclampsiaPhase 4DIUPRENCT02163655
Diuretics for Postpartum High Blood Pressure in Preeclampsia
A Phase 4 study testing FUROSEMIDE in people with Preeclampsia, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
Trial summary
The purpose of this study is to determine if furosemide administered after the first 24 hours of delivery, in women with severe peeclampsia and eclampsia accelerates high blood pressure control and diminishes hospital stay. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- FUROSEMIDE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jun 2014to Aug 2015
- Phase
- Phase 4
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preeclampsia
- Urine output > 50ml/h
- End of postpartum magnesium sulphate
Who cannot join
- Cronic hypertension
- Bloor pressure < 140mmHg and < 90mmHg
- Diuretic use
- Renal impairment
- Diabetes, sickle cell disease ou rheumatologic disease
- Hemodinamic instability
- Potassium < 3mEq/L
- Contraindications for fusoremide use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Postpartum Furosemide on Recovery Blood Pressure in Puerperal Women with Severe Preeclampsia: a Randomized Clinical Trial
The purpose of this study is to determine if furosemide administered after the first 24 hours of delivery, in women with severe peeclampsia and eclampsia accelerates high blood pressure control and diminishes hospital stay.
Read the detailed description
A placebo-controlled study that will be conducted including 120 postpartum women with severe preeclampsia . Women who are previosuly diuretic users, with renal impairment, hemodynamic instability or with contraindications to diuretic use will be excluded. Informed consent will be obtained from all participants . Patients will be randomized to receive furosemide ( 40mg orally every twenty-four hours ) or placebo for maximum of five days. The variables are systolic and diastolic blood pressure, frequency of very high blood pressure, need for maintenance of antihypertensive therapy , number of antihypertensive agents used to control blood pressure , urine output , length of hospital stay , adverse effects and maternal complications . Except for the study drug, patients will receive all care and monitoring according to the hospital protocol and decision to initiate or modify antihypertensive therapy will be defined by the attending physician, as well as the decision to discharge. If the patient is discharged before five days of the protocol drug, this drug will be stopped. Teh patients may decide to leave the study at any moment. Data will be collected by researches daily. Plan statistical analysis will be performed using the public domain program Epi Info 7.0 and the mean and dispersion measures for numerical variables will be calculated. To compare means obtained every day and between groups will be used analysis of variance ( ANOVA ) . Nominal variables were compared using the X2 test or Fisher if necessary. Be considered significant at p < 0,05. The risk ratio (RR) is calculated as a measure of the relative risk for the different outcomes , according to furosemide or placebo
- Conditions
- Preeclampsia
- Being tested
- FUROSEMIDE, Placebo
- Keywords
- preeclampsia, very high blood pressure, diuretics
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FUROSEMIDEDrug
Also called Lasix
Furosemide, 20mg pills, will be administered every 24 houras, for a maximum of five days
PlaceboDrug
Placebo pills, identical to the intervention (furosemide pills), will be administered every 24 hour for a maximum of five days
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO | Placebo comparator | PLACEBO: placebo, oral, every 24 hours for maximum 5 days Receives: Drug: Placebo |
| FUROSEMIDE | Experimental | FUROSEMIDE: 20mg furosemide, oral, every 24 hours for maximum 5 days Receives: Drug: FUROSEMIDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean blood pressure
Measured: from 24 hours after delivery to first 15 days of delivery
Secondary outcomes (4)
postpartum hospital stay
Time until discharge of the hospital
Measured: from 24 hours after delivery to 15 days
Maintenance of antihypertensive therapy
Number of antihypertensive agents used to control blood pressure at hospital discharge; time elapsed to control blood pressure; daily urine output; reduction of edema; length of hospital stay; frequency of adverse effects: hypokalemia, polydipsia, headache, mental confusion, muscle pain, tetany, muscle weakness, heart rhythm disturbances and gastrointestinal symptoms; frequency of maternal complications: imminent eclampsia, eclampsia, infection, bleeding manifestations, shock and maternal death.
Measured: From 24 hours up to 15 days of delivery
frequency of adverse effects
Presence of hypokalemia, polydipsia, headache, mental confusion, muscle pain, tetany, muscle weakness, heart rhythm disturbances and gastrointestinal symptoms;
Measured: From 24 hours to 15 days after delivery
frequency of maternal complications
Frequency of imminent eclampsia, eclampsia, infection, bleeding manifestations, shock and maternal death.
Measured: From 24 hours up to 15 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study start20 Jun 2014
- Primary completion30 Nov 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
- Investigators
- Leila Katz, MD PhD, Study director, IMIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163655
- Sponsor's protocol ID
- DIUPRE
- Other IDs
- DIUPRE
- Acronym
- DIUPRE
- Status last verified
- Jul 2021
- First submitted
- 9 Jun 2014
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cursino T, Katz L, Coutinho I, Amorim M. Diuretics vs. placebo for postpartum blood pressure control in preeclampsia (DIUPRE): a randomized clinical trial. Reprod Health. 2015 Aug 5;12:66. doi: 10.1186/s12978-015-0057-0.
PubMed 26242730
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Postpartum Furosemide on Recovery Blood Pressure in Puerperal Women with Severe Preeclampsia: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02163655
- Acronym / sponsor ID
- DIUPRE / DIUPRE
- Conditions
- Preeclampsia
- Keywords
- preeclampsia, very high blood pressure, diuretics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Study start
- 20 Jun 2014 (actual)
- Primary completion
- 30 Nov 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Jun 2014 (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 if furosemide administered after the first 24 hours of delivery, in women with severe peeclampsia and eclampsia accelerates high blood pressure control and diminishes hospital stay.
Detailed description
A placebo-controlled study that will be conducted including 120 postpartum women with severe preeclampsia . Women who are previosuly diuretic users, with renal impairment, hemodynamic instability or with contraindications to diuretic use will be excluded. Informed consent will be obtained from all participants . Patients will be randomized to receive furosemide ( 40mg orally every twenty-four hours ) or placebo for maximum of five days. The variables are systolic and diastolic blood pressure, frequency of very high blood pressure, need for maintenance of antihypertensive therapy , number of antihypertensive agents used to control blood pressure , urine output , length of hospital stay , adverse effects and maternal complications . Except for the study drug, patients will receive all care and monitoring according to the hospital protocol and decision to initiate or modify antihypertensive therapy will be defined by the attending physician, as well as the decision to discharge. If the patient is discharged before five days of the protocol drug, this drug will be stopped. Teh patients may decide to leave the study at any moment. Data will be collected by researches daily. Plan statistical analysis will be performed using the public domain program Epi Info 7.0 and the mean and dispersion measures for numerical variables will be calculated. To compare means obtained every day and between groups will be used analysis of variance ( ANOVA ) . Nominal variables were compared using the X2 test or Fisher if necessary. Be considered significant at p < 0,05. The risk ratio (RR) is calculated as a measure of the relative risk for the different outcomes , according to furosemide or placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLACEBO | Placebo comparator | Drug: PlaceboPLACEBO: placebo, oral, every 24 hours for maximum 5 days |
| FUROSEMIDE | Experimental | Drug: FUROSEMIDEFUROSEMIDE: 20mg furosemide, oral, every 24 hours for maximum 5 days |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Preeclampsia
- Urine output > 50ml/h
- End of postpartum magnesium sulphate
Key exclusion criteria (8 listed)
- Cronic hypertension
- Bloor pressure < 140mmHg and < 90mmHg
- Diuretic use
- Renal impairment
- Diabetes, sickle cell disease ou rheumatologic disease
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: LasixFurosemide, 20mg pills, will be administered every 24 houras, for a maximum of five days | Drug | FUROSEMIDE |
| PlaceboPlacebo pills, identical to the intervention (furosemide pills), will be administered every 24 hour for a maximum of five days | Drug | PLACEBO |
Primary outcome
Mean blood pressure
Time frame: from 24 hours after delivery to first 15 days of delivery
4 secondary outcomes
postpartum hospital stay
Time frame: from 24 hours after delivery to 15 days
Maintenance of antihypertensive therapy
Time frame: From 24 hours up to 15 days of delivery
frequency of adverse effects
Time frame: From 24 hours to 15 days after delivery
frequency of maternal complications
Time frame: From 24 hours up to 15 days after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Derived from this study: PubMed 26242730Cursino T, Katz L, Coutinho I, Amorim M. Diuretics vs. placebo for postpartum blood pressure control in preeclampsia (DIUPRE): a randomized clinical trial. Reprod Health. 2015 Aug 5;12:66. doi: 10.1186/s12978-015-0057-0.
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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.
Leila Katz, MD PhD study director
IMIP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FUROSEMIDE in people with Preeclampsia, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
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 3 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: finished, as of the sponsor's last update on 2 Oct 2024. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean blood pressure (time frame: from 24 hours after delivery to first 15 days of delivery). 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 NCT02163655, 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 2 Oct 2024.