Maternal-Fetal ExchangeNCT01698957
Maternal Uterine Artery Doppler Study
An observational study of Maternal-Fetal Exchange, run by Obstetrix Medical Group at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal-Fetal Exchange
- What is being tested?
- Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- Multiple gestation
- Less than 18 weeks gestation
- Uterine anomalies
- Fetal anomalies
- Preeclampsia
- Hypertension
- Inability to have BP cuff on left arm
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Phoenix Perinatal Associates
Glendale, Arizona, 85308
Phoenix Perinatal Associates
Phoenix, Arizona, 85014
About this study
Official title: A Simple Technique to Modify Maternal Uterine Artery Perfusion.
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.
Read the 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.
- Conditions
- Maternal-Fetal Exchange
- Being tested
- Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.
- Keywords
- Pregnant women, Uterine Artery Doppler Velocimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| UA Doppler Velocimetry | Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly. Receives: Other: Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at time of routine ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal-Fetal ExchangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obstetrix Medical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas H Strong, MD, Principal investigator, Obstetrix Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698957
- Sponsor's protocol ID
- UA Doppler 2012
- Status last verified
- Nov 2016
- First submitted
- 1 Oct 2012
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simple Technique to Modify Maternal Uterine Artery Perfusion.
- ClinicalTrials.gov ID
- NCT01698957
- Acronym / sponsor ID
- UA Doppler 2012
- Conditions
- Maternal-Fetal Exchange
- Keywords
- Pregnant women, Uterine Artery Doppler Velocimetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Obstetrix Medical GroupIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UA Doppler Velocimetry | – | Other: Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Multiple gestation
- Less than 18 weeks gestation
- Uterine anomalies
- Fetal anomalies
- Preeclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | UA Doppler Velocimetry |
Primary outcome
Uterine Artery Doppler
Time frame: at time of routine ultrasound
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas H Strong, MD principal investigator
Obstetrix Medical Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal-Fetal Exchange, run by Obstetrix Medical Group at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine Artery Doppler (time frame: at time of routine ultrasound). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.