Comparison Fetal Hemodynamic Measurements Antihypertensive Versus Control

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by State University of New York - Upstate Medical University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00759278
First received: September 24, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

This is a prospective case-control study to evaluate women who are pregnant and take antihypertensive medication for fetal hemodynamics (middle cerebral artery peak systolic flow and umbilical artery Doppler systolic to diastolic ratio) compared to a control group of pregnant women not taking these kinds of medications. The hypothesis is that the investigators expect to observe little to no difference in the comparison between the medication group and the control group.


Condition Intervention
Hypertension
Pregnancy
Procedure: ultrasound evaluation in pregnancy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Comparison of Fetal Hemodynamic Measurements Between Pregnant Women Taking Anti-Hypertensive Medication and Controls

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • Fetal ultrasound assessment of middle cerebral artery and umbilical artery blood flow [ Time Frame: 26 to 33 weeks gestation and 34 to 40 weeks gestational age ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Group of 30 women who are pregnant as subjects that take antihypertensive medication
Procedure: ultrasound evaluation in pregnancy
Subjects enrolled will have a series of ultrasound evaluations to assess parameters in the study. Ultrasound is a non-invasive technique for creating images that does not use radiation and is routine in obstetrical practice
Other Name: Sonogram
2
Group of 30 women who are pregnant and do not take antihypertensive medications as a control group
Procedure: ultrasound evaluation in pregnancy
Subjects enrolled will have a series of ultrasound evaluations to assess parameters in the study. Ultrasound is a non-invasive technique for creating images that does not use radiation and is routine in obstetrical practice
Other Name: Sonogram

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women with established singleton pregnancy at least 18 years of age, with diagnosis of chronic hypertension or with no diagnosis of hypertension

Criteria

Inclusion Criteria:

  1. At least 18 years of age
  2. A diagnosis of chronic hypertension by at least one of these criteria including hypertension that has persisted beyond the postpartum time frame of a prior pregnancy, hypertension diagnosed and managed before current pregnancy, or elevated blood pressure (systolic blood pressure > or = 140 mmHg or diastolic blood pressure > or = 90 mmHg) prior to 20 weeks gestation requiring medication management
  3. Taking medication for control of chronic hypertension prior to study entry
  4. Potential subjects taking medications for control of cardiac arrythmia that fall into the anti-hypertensive class will be considered for this cohort

Potential subjects for the control cohort:

  1. At least 18 years of age
  2. Absence of a diagnosis of chronic hypertension
  3. Not taking medication for control of chronic hypertension or arrythmia

Exclusion Criteria:

  1. Less than 18 years of age
  2. Pregnancy complicated by significant fetal chromosomal anomaly, severe or multiple fetal anomalies, early onset amniotic fluid abnormalities, preterm labor, placental abruption, or IUGR
  3. Inability to complete the informed consent process or participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759278

Contacts
Contact: John J Folk, M.D. 315.464.4736 folkj@upstate.edu

Locations
United States, New York
Regional Perinatal Center University Health Care Center Not yet recruiting
Syracuse, New York, United States, 13202
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: John J Folk, M.D. State University of New York - Upstate Medical University
  More Information

Publications:
Haddad B, Sibai BM. Chronic hypertension in pregnancy. Ann Med 31: 246-252, 1999.
Harman CR. Chapter 21 Assessment of fetal health. Creasy RK, Resnik R, Iams JD (eds)Maternal-Fetal Medicine: Principles and Practice, 5th Edition. 2004; Saunders, Philadephia, Pennsylvania, 372.

Responsible Party: John J. Folk, M.D., SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT00759278     History of Changes
Other Study ID Numbers: IRBPHS 5215
Study First Received: September 24, 2008
Last Updated: September 24, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
pregnancy
umbilical artery systolic to diastolic flow ratio
middle cerebral artery peak systolic flow
antihypertensive medication

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014