Preterm Preeclampsia
Conditions
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.
Interventions
DRUGSildenafil
DRUGPlacebo
Color and size matched to active drug (sildenafil)
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed