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

NCT01351428 | Completed

• 1 other identifier: 10-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pre-Eclampsia; Pregnancy; Hypertension

Keywords

Non invasive cardiac output monitor; NICOM; Hypertension; Pregnancy; Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

• Systemic vascular resistance

  Systemic vascular resistance is measured at the above time points, and more frequently at the discretion of the attending obstetrician.

  20-22, 24-26, 28, 30-32 and 36 weeks gestational age

Secondary Outcomes (7)

• Maximum change in maternal blood pressure

  20-22, 24-26, 28, 30-32 and 36 weeks gestational age

• Gestational age at delivery

  25-41 weeks gestational age

• Fetal weight at delivery

  25-41 weeks gestational age

• Gestational age at time of first hospitalization

  25-41 weeks gestational age

• Gestational age at peak maternal blood pressure

  20-41 weeks

Study Arms (1)

NICOM group

EXPERIMENTAL

Vasodilator therapy begins when SVR increases by 20% or greater than baseline. Therapy is titrated according to hemodynamic profile and clinical signs and symptoms.

Drug: Nifedipine

Interventions

Nifedipine DRUG

30-60 mg, twice daily

Also known as: Adalat XL

NICOM group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jose CA Carvalho, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: May 10, 2011
• Study Start: December 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 12, 2012

Record last verified: 2012-11

Locations

CA (1)