search
Back to results

Efficacy of Sildenafil in Preterm Preeclampsia (SIL)

Primary Purpose

Preterm Preeclampsia

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sildenafil
Placebo
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Preeclampsia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Sildenafil

    Placebo

    Arm Description

    Sildenafil 40mg oral tablet three times a day from randomization until delivery

    Matched to oral capsule of active treatment three times a day from randomization until delivery

    Outcomes

    Primary Outcome Measures

    Latency (duration of pregnancy from diagnosis/randomization until delivery)
    earliest randomization can occur at 24 weeks gestation

    Secondary Outcome Measures

    Full Information

    First Posted
    February 11, 2016
    Last Updated
    March 23, 2018
    Sponsor
    The University of Texas Health Science Center, Houston
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02782559
    Brief Title
    Efficacy of Sildenafil in Preterm Preeclampsia
    Acronym
    SIL
    Official Title
    Randomized Double-Blind, Placebo Controlled Evaluation of the Efficacy of Sildenafil Versus Placebo in Preterm Preeclampsia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    difficulties acquiring the drug and funding for the drug
    Study Start Date
    July 2016 (Anticipated)
    Primary Completion Date
    July 2017 (Anticipated)
    Study Completion Date
    July 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Texas Health Science Center, Houston

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Preeclampsia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sildenafil
    Arm Type
    Experimental
    Arm Description
    Sildenafil 40mg oral tablet three times a day from randomization until delivery
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Matched to oral capsule of active treatment three times a day from randomization until delivery
    Intervention Type
    Drug
    Intervention Name(s)
    Sildenafil
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Color and size matched to active drug (sildenafil)
    Primary Outcome Measure Information:
    Title
    Latency (duration of pregnancy from diagnosis/randomization until delivery)
    Description
    earliest randomization can occur at 24 weeks gestation
    Time Frame
    Diagnosis (randomization) until delivery, up to 34 weeks)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robyn P Roberts, MD
    Organizational Affiliation
    The University of Texas Health Science Center, Houston
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Efficacy of Sildenafil in Preterm Preeclampsia

    We'll reach out to this number within 24 hrs