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Efficacy of Sildenafil in Preterm Preeclampsia (SIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02782559
Recruitment Status : Withdrawn (difficulties acquiring the drug and funding for the drug)
First Posted : May 25, 2016
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center, Houston

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

Condition or disease Intervention/treatment Phase
Preterm Preeclampsia Drug: Sildenafil Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double-Blind, Placebo Controlled Evaluation of the Efficacy of Sildenafil Versus Placebo in Preterm Preeclampsia
Estimated Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sildenafil
Sildenafil 40mg oral tablet three times a day from randomization until delivery
Drug: Sildenafil
Placebo Comparator: Placebo
Matched to oral capsule of active treatment three times a day from randomization until delivery
Drug: Sildenafil
Drug: Placebo
Color and size matched to active drug (sildenafil)




Primary Outcome Measures :
  1. Latency (duration of pregnancy from diagnosis/randomization until delivery) [ Time Frame: Diagnosis (randomization) until delivery, up to 34 weeks) ]
    earliest randomization can occur at 24 weeks gestation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782559


Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Robyn P Roberts, MD The University of Texas Health Science Center, Houston
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Responsible Party: The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02782559    
Other Study ID Numbers: HSC-MS-16-0083
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Premature Birth
Pre-Eclampsia
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Hypertension, Pregnancy-Induced
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents