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Withdrawn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
About this trial
This is an interventional treatment trial for Preterm Preeclampsia
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
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
NCT ID
NCT02782559
First Posted
February 11, 2016
Last Updated
March 23, 2018
Sponsor
The University of Texas Health Science Center, Houston
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Withdrawn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
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