NCT01698957

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

3.9 years

First QC Date

October 1, 2012

Last Update Submit

November 21, 2016

Conditions

Maternal-Fetal Exchange

Keywords

Pregnant womenUterine Artery Doppler Velocimetry

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Interventions

Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.OTHER

bilateral Uterine artery Doppler readings pre- and during blood pressure measurement

UA Doppler Velocimetry

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Phoenix Perinatal Associates

Glendale, Arizona, 85308, United States

Location

Phoenix Perinatal Associates

Phoenix, Arizona, 85014, United States

Location

MeSH Terms

Interventions

Pregnancy

Intervention Hierarchy (Ancestors)

ReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Thomas H Strong, MD

    Obstetrix Medical Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2012

First Posted

October 3, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

November 22, 2016

Record last verified: 2016-11

Locations

US(2)