ClinicalTrials.gg
CompletedNCT01351428Updated Nov 12, 2012

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

An interventional study of Nifedipine in Pre-Eclampsia, Pregnancy and Hypertension, sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital. Completed at 1 site in Canada. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-11-12.

Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

Read the detailed description

Invasive hemodynamic techniques have long identified significant increases in heart rate (HR), blood volume, left ventricular end-diastolic volume (LVEDV), stroke volume (SV) and cardiac output (CO) during the first and second trimesters of pregnancy. In normal pregnancy, CO increases from as early as 5 weeks gestation, with a 30-40% increase by the end of the first trimester of pregnancy. Cardiac output continues to rise throughout the second trimester until it reaches a level approximately 50% greater than that of non-pregnant women. Cardiac output slightly decreases during the third trimester. Despite these changes, maternal blood pressure (BP) still falls due to a large reduction in systemic vascular resistance (SVR) from systemic vasodilatation and the formation of a low-resistance utero-placental circulation. Systemic vascular resistance falls during early gestation, reaching its nadir (35% decline) at 20 weeks gestation, and rises during late pregnancy.

Transthoracic bioreactance is a newer technique of non-invasive continuous cardiac output monitoring. It is based on an analysis of relative phase shifts of oscillating currents that occur when this current traverses the thoracic cavity, as opposed to the traditional bioimpedance-based system, which rely only on measured changes in signal amplitude. Unlike bioimpedance, bioreactance-based non-invasive CO measurement does not use the static impedance and does not depend on the distance between the electrodes for the calculations of SV and CO, which significantly reduces the uncertainty in the result. Moreover, its readings were shown to correlate well with results derived from pulmonary artery catheter derived measurement of cardiac output. In addition, it has also been shown that the non-invasive cardiac output measurement (NICOM®) system has acceptable accuracy, precision and responsiveness for CO monitoring in patients experiencing a wide range of circulatory situations and has recently been used in the obstetric population.

The purpose of this study is to use non-invasive cardiac output monitoring to capture the earliest inappropriate rise in SVR during the pre clinical phase of disease, in patients at high risk of developing preeclampsia, as predicted by the placenta profile. In case an increase in SVR is identified, the purpose of this study is to implement a goal-directed therapy in an attempt to decrease the severity, and postpone the onset of clinical disease.

The hypothesis of this study is that the increases in SVR detected during the pre-clinical phase of preeclampsia can be treated with a goal directed therapy without fetal compromise and that this intervention may improve maternal and fetal/neonatal outcome.

02

Conditions studied

  • Pre-Eclampsia
  • Pregnancy
  • Hypertension

Keywords

  • Non invasive cardiac output monitor
  • NICOM
  • Hypertension
  • Pregnancy
  • Pre-Eclampsia
03

In context

Pre-Eclampsia

903 studies on the registry are indexed under Pre-Eclampsia; 240 are open to participants now.

This study's enrollment of 20 is below the median of 110 across 478 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital is the lead sponsor of 137 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    NICOM group

    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

  • 30-60 mg, twice daily

    Also known as: Adalat XL

06

What researchers measure

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.

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

Secondary outcomes

  1. Maximum change in maternal blood pressure

    Blood pressure is taken on the NICOM at the above time points, and more frequently at obstetric appointments in between.

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

  2. Gestational age at delivery

    Time frame: 25-41 weeks gestational age

  3. Fetal weight at delivery

    Time frame: 25-41 weeks gestational age

  4. Gestational age at time of first hospitalization

    Time frame: 25-41 weeks gestational age

  5. Gestational age at peak maternal blood pressure

    Time frame: 20-41 weeks

  6. Gestational age at which steroids are administered

    Time frame: 25-41 weeks gestational age

  7. Serum s-Flt and PlGF levels

    Time frame: 12-41 weeks gestational age

07

Study locations

1 site
  • Mount Sinai Hospital
    Toronto, Ontario M5G1X5, Canada
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2010, a primary completion of Nov 2012 and a completion of Nov 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2011
First posted
May 10, 2011
Start
Dec 2010
Primary completionActual
Nov 2012
CompletionActual
Nov 2012
Last update
Nov 12, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01351428
Responsible party
Sponsor
First posted
May 10, 2011
Start date
Dec 2010
Primary completion
Nov 2012
Completion
Nov 2012
Last update
Nov 12, 2012

Study contacts

Jose CA Carvalho, MD
principal investigator · MOUNT SINAI HOSPITAL

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Nifedipine

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