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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01698957
Other study ID # UA Doppler 2012
Secondary ID
Status Completed
Phase N/A
First received October 1, 2012
Last updated November 21, 2016
Start date September 2012
Est. completion date September 2016

Study information

Verified date November 2016
Source Mednax Center for Research, Education and Quality
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date September 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.
bilateral Uterine artery Doppler readings pre- and during blood pressure measurement

Locations

Country Name City State
United States Phoenix Perinatal Associates Glendale Arizona
United States Phoenix Perinatal Associates Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Obstetrix Medical Group

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Uterine Artery Doppler 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. at time of routine ultrasound No
See also
  Status Clinical Trial Phase
Completed NCT03265704 - Maternal High Blood Pressure and Newborn's Blood Profile N/A