Efficacy of Sildenafil in Preterm Preeclampsia (SIL)

Randomized Double-Blind, Placebo Controlled Evaluation of the Efficacy of Sildenafil Versus Placebo in Preterm Preeclampsia

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

Study Overview

• Status: Withdrawn
• Conditions: Preterm Preeclampsia
• Intervention / Treatment: Drug: Sildenafil; Drug: Placebo

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Robyn P Roberts, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2016
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: February 11, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 25, 2016

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 23, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Hypertension, Pregnancy-Induced; Premature Birth; Pre-Eclampsia; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: HSC-MS-16-0083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES