Efficacy of Sildenafil in Preterm Preeclampsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Preterm Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sildenafil

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

Group Type EXPERIMENTAL

Sildenafil

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Sildenafil

Intervention Type DRUG

Placebo

Intervention Type DRUG

Color and size matched to active drug (sildenafil)

Interventions

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Sildenafil

Intervention Type DRUG

Placebo

Color and size matched to active drug (sildenafil)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No