Efficacy of Sildenafil in Preterm Preeclampsia

Phase 2

Withdrawn

• Conditions: Preterm Preeclampsia
• Interventions: Drug: Sildenafil; Drug: Placebo

• Registration Number: NCT02782559
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-25
• Study Start: 2016-07
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-23
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matched to oral capsule of active treatment three times a day from randomization until delivery
Sildenafil	Sildenafil	Sildenafil 40mg oral tablet three times a day from randomization until delivery
Placebo	Sildenafil	Matched to oral capsule of active treatment three times a day from randomization until delivery

Primary Outcome Measures

Name	Time	Method
Latency (duration of pregnancy from diagnosis/randomization until delivery)	Diagnosis (randomization) until delivery, up to 34 weeks)	earliest randomization can occur at 24 weeks gestation