Hemodynamic Assessment of Healthy and Hypertensive Pregnant Women by Non-Invasive Bio-Reactance

NCT00949260 | Completed

• 1 other identifier: 09-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a noninvasive method of measuring certain aspects of blood circulation (e.g., blood pressure, cardiac output) is an accurate and reliable method to detect changes in pregnant patients. Specifically,the investigators are interested in patients diagnosed with high blood pressure during their pregnancy, as compared with normal pregnant patients. A noninvasive, accurate method of taking these measurements in pregnant patients is not currently available.

Conditions

Hypertension, Pregnancy-Induced

Keywords

PIH; pregnancy induced hypertension; pregnancy; bioimpedance; noninvasive monitoring; Cardiac Output; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Cardiac Index (CI)

  20 minutes

Secondary Outcomes (3)

• Cardiac Output (CO)

  20 minutes

• Blood Pressure (BP)

  20 minutes

• Systemic Vascular Resistance (SVR)

  20 minutes

Study Arms (3)

Normal, Non-Pregnant

Normal, non-pregnant patients will have 15 minutes of monitoring at rest, followed by a passive leg raising test.

Normal, Pregnant

Normal, pregnant patients in their 3rd trimester will have 15 minutes of monitoring at rest, followed by a passive leg raising test.

Pregnant, PIH

Pregnant patients in their 3rd trimester with pregnancy-induced hypertension that has not been treated will have 15 minutes of monitoring at rest, followed by a passive leg raising test.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Our study population includes healthy non-pregnant and pregnant patients in their 3rd trimester, as well as pregnant patients in their 3rd trimester with pregnancy-induced hypertension (PIH). Both normal groups will be recruited from the outpatient day-unit (healthy volunteers). Patients with PIH may be sent to labour and delivery for monitoring by their obstetricians.

You may qualify if:

• PIH diagnosed in 3rd trimester, not yet treated
• healthy pregnant patients in 3rd trimester
• healthy non-pregnant women

You may not qualify if:

• under age 18 or above age 40
• refusal to participate

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jose Carvalho, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: July 30, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 26, 2010

Record last verified: 2010-03

Locations

CA (1)