Comparison Fetal Hemodynamic Measurements Antihypertensive Versus Control - Full Text View

Sponsored by:	State University of New York - Upstate Medical University
Information provided by:	State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:	NCT00759278

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:	Case Control, Prospective
Official Title:	A Comparison of Fetal Hemodynamic Measurements Between Pregnant Women Taking Anti-Hypertensive Medication and Controls

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure Ultrasound

U.S. FDA Resources

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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
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

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:

At least 18 years of age
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
Taking medication for control of chronic hypertension prior to study entry
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:

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

Exclusion Criteria:

Less than 18 years of age
Pregnancy complicated by significant fetal chromosomal anomaly, severe or multiple fetal anomalies, early onset amniotic fluid abnormalities, preterm labor, placental abruption, or IUGR
Inability to complete the informed consent process or participate in the study

Contacts and Locations

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
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.

[No authors listed] National High Blood Pressure Education Program Working Group Report on High Blood Pressure in Pregnancy. Am J Obstet Gynecol. 1990 Nov;163(5 Pt 1):1691-712. Review.

Ferrer RL, Sibai BM, Mulrow CD, Chiquette E, Stevens KR, Cornell J. Management of mild chronic hypertension during pregnancy: a review. Obstet Gynecol. 2000 Nov;96(5 Pt 2):849-60. Review.

Sibai BM, Anderson GD. Pregnancy outcome of intensive therapy in severe hypertension in first trimester. Obstet Gynecol. 1986 Apr;67(4):517-22.

von Dadelszen P, Ornstein MP, Bull SB, Logan AG, Koren G, Magee LA. Fall in mean arterial pressure and fetal growth restriction in pregnancy hypertension: a meta-analysis. Lancet. 2000 Jan 8;355(9198):87-92.

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.

Erskine RL, Ritchie JW. Umbilical artery blood flow characteristics in normal and growth-retarded fetuses. Br J Obstet Gynaecol. 1985 Jun;92(6):605-10.

Reuwer PJ, Bruinse HW, Stoutenbeek P, Haspels AA. Doppler assessment of the fetoplacental circulation in normal and growth-retarded fetuses. Eur J Obstet Gynecol Reprod Biol. 1984 Nov;18(4):199-205.

Trudinger BJ, Cook CM, Giles WB, Connelly A, Thompson RS. Umbilical artery flow velocity waveforms in high-risk pregnancy. Randomised controlled trial. Lancet. 1987 Jan 24;1(8526):188-90.

Omtzigt AM, Reuwer PJ, Bruinse HW. A randomized controlled trial on the clinical value of umbilical Doppler velocimetry in antenatal care. Am J Obstet Gynecol. 1994 Feb;170(2):625-34.

Gazzolo D, Visser GH, Russo A, Scopesi F, Santi F, Bruschettini PL. Pregnancy-induced hypertension, antihypertensive drugs and the development of fetal behavioural states. Early Hum Dev. 1998 Jan 9;50(2):149-57.

Günenç O, Ciçek N, Görkemli H, Celik C, Acar A, Akyürek C. The effect of methyldopa treatment on uterine, umblical and fetal middle cerebral artery blood flows in preeclamptic patients. Arch Gynecol Obstet. 2002 Jul;266(3):141-4.

Houlihan DD, Dennedy MC, Ravikumar N, Morrison JJ. Anti-hypertensive therapy and the feto-placental circulation: effects on umbilical artery resistance. J Perinat Med. 2004;32(4):315-9.

Responsible Party:	SUNY Upstate Medical University ( John J. Folk, M.D. )
Study ID Numbers:	IRBPHS 5215
Study First Received:	September 24, 2008
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00759278 History of Changes
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

Study placed in the following topic categories:

Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Vascular Diseases
Cardiovascular Diseases
Cardiovascular Agents

Antihypertensive Agents
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on September 11, 2009