Efficacy of Sildenafil in Preterm Preeclampsia

Preterm Preeclampsia Clinical Trial

— SIL  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02782559
• Other study ID #: HSC-MS-16-0083
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: February 11, 2016
• Last updated: March 23, 2018
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: March 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Premature Birth
• Preterm Preeclampsia

Intervention

Drug:
• Sildenafil

• Placebo
Color and size matched to active drug (sildenafil)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)