Goal-Directed Therapy in Pregnant Women at High Risk of Developing Preeclampsia

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

Preeclampsia is associated with significant maternal and fetal morbidity and mortality. Early identification and subsequent management of patients at risk of developing preeclampsia presents an ongoing challenge in prenatal care. Some at risk pregnancies may be identified from:

• serum screening abnormalities in the first or second trimester

• placental shape and texture at the 18-20 anatomical ultrasound

• uterine artery blood flow.

Early identification and effective treatment of patients would permit the safe completion of the pregnancy for the mother and infant. Recent advances in non-invasive cardiovascular monitoring have enabled the study of maternal hemodynamics in normal and at-risk pregnancies. This study hopes to identify the earliest significant changes in maternal hemodynamics which may allow targeted therapeutic interventions in patients at high risk of developing preeclampsia.

The hypothesis of this study is that systemic vascular resistance rises during the pre-clinical phase of preeclampsia and this can be captured using non invasive bioreactance technology. Treatment of the abnormally high vascular tone may decrease the severity and postpone the onset of clinical disease.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Treatments: Nifedipine

Criteria

Inclusion Criteria:

• Risk factors for preeclampsia/IUGR - medical or obstetric

• Abnormal uterine artery Doppler

• Two of the following:

Abnormal placental biochemistry Abnormal placental shape Abnormal placental texture

Exclusion Criteria:

• Multifetal pregnancy

• Fetal abnormality, including nuchal translucency more than 3mm at 12 weeks

• Preterm labor/pprom/bleeding/rescue cerclage (excluding elective 12 week prophylactic cerclage)

• Type 1 diabetes mellitus

• Heparin use

• Chronic hypertension on treatment before 20 weeks

• Documented chronic renal disease