NCT02163655

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

June 20, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 2, 2024

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

June 9, 2014

Last Update Submit

September 30, 2024

Conditions

Keywords

preeclampsia, very high blood pressure, diuretics

Outcome Measures

Primary Outcomes (1)

  • Mean blood pressure

    from 24 hours after delivery to first 15 days of delivery

Secondary Outcomes (4)

  • postpartum hospital stay

    from 24 hours after delivery to 15 days

  • Maintenance of antihypertensive therapy

    From 24 hours up to 15 days of delivery

  • frequency of adverse effects

    From 24 hours to 15 days after delivery

  • frequency of maternal complications

    From 24 hours up to 15 days after delivery

Other Outcomes (2)

  • Frequency of very high blood pressure episode

    from 24 hours after delivery until 15 days after delivery

  • Blood pressure control

    From 24 hours after delivery to 15 days

Study Arms (2)

PLACEBO

PLACEBO COMPARATOR

PLACEBO: placebo, oral, every 24 hours for maximum 5 days

Drug: Placebo

FUROSEMIDE

EXPERIMENTAL

FUROSEMIDE: 20mg furosemide, oral, every 24 hours for maximum 5 days

Drug: FUROSEMIDE

Interventions

Furosemide, 20mg pills, will be administered every 24 houras, for a maximum of five days

Also known as: Lasix
FUROSEMIDE

Placebo pills, identical to the intervention (furosemide pills), will be administered every 24 hour for a maximum of five days

PLACEBO

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Preeclampsia
  • Urine output \> 50ml/h
  • End of postpartum magnesium sulphate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMIP

Recife, Pernambuco, 52020-070, Brazil

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • Leila Katz, MD PhD

    IMIP

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 9, 2014

First Posted

June 13, 2014

Study Start

June 20, 2014

Primary Completion

November 30, 2014

Study Completion

August 1, 2015

Last Updated

October 2, 2024

Record last verified: 2021-07

Locations