Efficacy of Sildenafil in Preterm Preeclampsia | NCT02782559

Studies
Efficacy of Sildenafil in Preterm Preeclampsia

NCT02782559

Sponsor

The University of Texas Health Science Center, Houston

Status

Withdrawn

Last Update Posted

Mar 27, 2018Actual

Enrollment

0Actual

Phase

Phase 2Phase 3

Conditions

Preterm Preeclampsia

Interventions

Sildenafil
Placebo

Countries

Not provided

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

Mar 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

difficulties acquiring the drug and funding for the drug

Expanded Access Info

Start Date

Jul 2016Estimated

Primary Completion Date

Jul 2017Estimated

Completion Date

Jul 2017Estimated

First Submitted Date

Feb 11, 2016

First Submission Date that Met QC Criteria

May 24, 2016

First Posted Date

May 25, 2016Estimated

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

Mar 23, 2018

Last Update Posted Date

Mar 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Randomized controlled trial to assess efficacy of Sildenafil in addition to expectant management for the treatment of preterm preeclampsia

Detailed Description

Preeclampsia is a major cause of maternal mortality. When preeclampsia presents prior to thirty-four weeks of gestation, expectant management is the standard practice in stable patients with the goal of extending pregnancy and therefore decreasing the risk of adverse outcomes in the premature neonate. Our aim was to assess the efficacy of Sildenafil, a phosphodiesterase inhibitor, versus placebo, in addition to expectant management, for the treatment of preterm preeclampsia to prolong pregnancy.

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 2Phase 3

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
Sildenafil	Experimental	Sildenafil 40mg oral tablet three times a day from randomization until delivery	Drug: Sildenafil
Placebo	Placebo Comparator	Matched to oral capsule of active treatment three times a day from randomization until delivery	Drug: Sildenafil Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sildenafil	Drug		Placebo Sildenafil
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Latency (duration of pregnancy from diagnosis/randomization until delivery)	earliest randomization can occur at 24 weeks gestation	Diagnosis (randomization) until delivery, up to 34 weeks)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hospitalized patients of gestational age of ≥24 0/7 weeks to ≤32 0/7 weeks.
Dating of pregnancy by ultrasound < or equal to 22 weeks or IVF conception
Diagnosis of Preterm Preeclampsia or Superimposed Preeclampsia

Exclusion Criteria:

Need for immediate delivery of the fetus
Known lethal anomaly
Pre-existing renal disease
Hypersensitivity to sildenafil
Pre-gestational diabetes, class C (onset prior to 10-19 or duration 10-19 yrs
Active peptic ulcer disease
Undergoing nitrate therapy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robyn P Roberts, MD	The University of Texas Health Science Center, Houston	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068677	Sildenafil Citrate

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457

Browse Leaves

Not provided

Browse Branches

Not provided