Maternal Uterine Artery Doppler Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Obstetrix Medical Group
Sponsor:
Information provided by (Responsible Party):
Obstetrix Medical Group
ClinicalTrials.gov Identifier:
NCT01698957
First received: October 1, 2012
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to detect if adding resistance to maternal blood flow from the arm will help increase the blood flow through the uterine arteries to the placenta and the baby.


Condition Intervention
Pregnant Women
Greater Than or Equal to 18 Weeks Gestation
Uterine Artery Doppler
Other: Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Simple Technique to Modify Maternal Uterine Artery Perfusion.

Further study details as provided by Obstetrix Medical Group:

Primary Outcome Measures:
  • Uterine Artery Doppler [ Time Frame: at time of routine ultrasound ] [ Designated as safety issue: No ]
    The purpose of this study is to detect if adding resistance to maternal blood flow from the arm will help increase the blood flow through the uterine arteries to the placenta and the baby.


Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
UA Doppler Velocimetry
Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.
Other: Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.

Detailed Description:

In the setting of uteroplacental insufficiency, there is little that can be done to increase blood flow through the uterus and placenta. Historically, women with growth restricted fetuses or oligohydramnios have been placed on bed rest. Unfortunately, this treatment modality has met with only limited success. Cardiologists have long recognized the simple act of making a fist or otherwise occluding blood flow through a limb dramatically increases a person's peripheral vascular resistance. If maternal peripheral resistance can be increased, perhaps the increased differential between the maternal peripheral vascular resistance and that of the uteroplacental unit will increase flow through the uterus and placenta.

  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

Pregnant women greater than or equal to 18 weeks gestation and 18 years old eligible for an ultrasound without fetal or uterine anomalies

Criteria

Inclusion Criteria:

  • Pregnant women greater than or equal to 18 years old
  • Able to speak and read English
  • Have a singleton pregnancy greater than or equal to 18 weeks gestation

Exclusion Criteria:

  • Multiple gestation
  • Less than 18 weeks gestation
  • Uterine anomalies
  • Fetal anomalies
  • Preeclampsia
  • Hypertension
  • Inability to have BP cuff on left arm
  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: NCT01698957

Locations
United States, Arizona
Phoenix Perinatal Associates Recruiting
Glendale, Arizona, United States, 85308
Contact: Ana Bodea-Braescu, MSN, MPH    602-614-0488    ana_braescu@pediatrix.com   
Contact: Thomas H Strong, MD    602-677-9234    thomas_strong@obstetrix.com   
Principal Investigator: Thomas H Strong, MD         
Phoenix Perinatal Associates Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Ana Bodea-Braescu, MSN, MPH    602-614-0488    ana_braescu@pediatrix.com   
Contact: Thomas H Strong, MD    602-677-9234    thomas_strong@obstetrix.com   
Principal Investigator: Thomas H Strong, MD         
Sponsors and Collaborators
Obstetrix Medical Group
Investigators
Principal Investigator: Thomas H Strong, MD Obstetrix Medical Group
  More Information

No publications provided

Responsible Party: Obstetrix Medical Group
ClinicalTrials.gov Identifier: NCT01698957     History of Changes
Other Study ID Numbers: UA Doppler 2012
Study First Received: October 1, 2012
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Obstetrix Medical Group:
Pregnant women
Uterine Artery Doppler Velocimetry

ClinicalTrials.gov processed this record on July 31, 2014