Comparison Fetal Hemodynamic Measurements Antihypertensive Versus Control

NCT00759278 | Withdrawn

• 1 other identifier: IRBPHS 5215
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Pregnancy

Keywords

pregnancy; umbilical artery systolic to diastolic flow ratio; middle cerebral artery peak systolic flow; antihypertensive medication

Outcome Measures

Primary Outcomes (1)

• Fetal ultrasound assessment of middle cerebral artery and umbilical artery blood flow

  26 to 33 weeks gestation and 34 to 40 weeks gestational age

Study Arms (2)

1

Group of 30 women who are pregnant as subjects that take antihypertensive medication

Procedure: ultrasound evaluation in pregnancy

2

Group of 30 women who are pregnant and do not take antihypertensive medications as a control group

Procedure: ultrasound evaluation in pregnancy

Interventions

ultrasound evaluation in pregnancy PROCEDURE

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

Also known as: Sonogram

1; 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

Regional Perinatal Center University Health Care Center

Syracuse, New York, 13202, United States

Location

Related Publications (15)

• Gilstrap LC, Ranin SM. Chronic hypertension in pregnancy. ACOG Practice Bulletin July 2001; 29.

  BACKGROUND

• Haddad B, Sibai BM. Chronic hypertension in pregnancy. Ann Med. 1999 Aug;31(4):246-52. doi: 10.3109/07853899908995887.

  PMID: 10480755 BACKGROUND

• 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. doi: 10.1016/0002-9378(90)90653-o.

  PMID: 2104525 BACKGROUND

• 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. doi: 10.1016/s0029-7844(00)00938-8.

  PMID: 11094241 BACKGROUND

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

  PMID: 3960423 BACKGROUND

• 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. doi: 10.1016/s0140-6736(98)08049-0.

  PMID: 10675164 BACKGROUND

• 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.

  BACKGROUND

• Rouse DJ. Antepartum fetal surveillance. ACOG Practice Bulletin, October 1999; 9.

  BACKGROUND

• 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. doi: 10.1111/j.1471-0528.1985.tb01399.x.

  PMID: 4005201 BACKGROUND

• 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. doi: 10.1016/0028-2243(84)90117-5.

  PMID: 6240422 BACKGROUND

• 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. doi: 10.1016/s0140-6736(87)90003-1.

  PMID: 2880017 BACKGROUND

• 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. doi: 10.1016/s0002-9378(94)70240-3.

  PMID: 8116724 BACKGROUND

• 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. doi: 10.1016/s0378-3732(97)00033-7.

  PMID: 9483388 BACKGROUND

• Gunenc O, Cicek N, Gorkemli H, Celik C, Acar A, Akyurek 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. doi: 10.1007/s004040100214.

  PMID: 12197552 BACKGROUND

• 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. doi: 10.1515/JPM.2004.058.

  PMID: 15346815 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Pregnancy; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• John J Folk, M.D.

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 13, 2021

Record last verified: 2021-10

Locations

US (1)