Efficacy of Sildenafil in Preterm Preeclampsia (SIL)

The University of Texas System (UT)

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Preterm Preeclampsia

Treatments: Drug: Placebo; Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT02782559

HSC-MS-16-0083

Details and patient eligibility

About

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

Full 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.

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Sildenafil

Experimental group

Description:

Sildenafil 40mg oral tablet three times a day from randomization until delivery

Treatment:

Drug: Sildenafil

Placebo

Placebo Comparator group

Description:

Matched to oral capsule of active treatment three times a day from randomization until delivery

Treatment:

Drug: Placebo

Drug: Sildenafil