Prevention of Severe Postpartum Hypertension | NCT02450773

Studies
Prevention of Severe Postpartum Hypertension

NCT02450773

Sponsor

Indiana University

Status

Withdrawn

Last Update Posted

May 11, 2023Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Hypertension

Interventions

Furosemide
Potassium chloride
Placebo #1
Placebo #2

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

May 2022Estimated

Completion Date

May 2022Estimated

First Submitted Date

May 11, 2015

First Submission Date that Met QC Criteria

May 18, 2015

First Posted Date

May 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2023

Last Update Posted Date

May 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Furosemide/Potassium chloride	Experimental	40 mg furosemide; 20 meq potassium chloride	Drug: Furosemide Drug: Potassium chloride
Placebo	Placebo Comparator	Placebo #1, Placebo #2	Drug: Placebo #1 Drug: Placebo #2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Furosemide	Drug	40 mg furosemide on postpartum day 1-6	Furosemide/Potassium chloride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite maternal morbidity	Requiring antihypertensive medication at discharge, readmission for blood pressure, end-organ damage from hypertension	0-6 weeks following delivery

Secondary Outcomes

Measure	Description	Time Frame
Adverse events associated with furosemide	Hypokalemia	0-6 weeks following delivery
Adverse events associated with furosemide	hyperglycemia

Other Outcomes

Measure	Description	Time Frame
Cardiovascular changes following delivery	Maternal echocardiogram, renin, aldosterone, B-natriuretic peptide levels	0-1 week following delivery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Methodius G Tuuli, MD, MPH	Indiana University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indiana University School of Medicine		Indianapolis	Indiana		United States
Washington University School of Medicine

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D011225	Pre-Eclampsia
D046110	Hypertension, Pregnancy-Induced

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005665	Furosemide
D011189	Potassium Chloride

Ancestor Terms

ID	Term
D013424	Sulfanilamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided