NCT02782559

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_2

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

February 11, 2016

Last Update Submit

March 23, 2018

Conditions

Preterm Preeclampsia

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

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: SildenafilDrug: Placebo

Interventions

SildenafilDRUG
PlaceboSildenafil
PlaceboDRUG

Color and size matched to active drug (sildenafil)

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Robyn P Roberts, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2016

First Posted

May 25, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

March 27, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share