Placenta Perfusion and Sufficiency Study

Study Overview
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Brief Summary
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Ultrasonography will be used to determine the total blood flow to and from the uterus. This is done by measuring the blood vessels coming from and going to the uterus. This wil hopefully prove viable and open the possibility to further research in the clinical relevance of these measurements.

Detailed Description
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This prospective pilot study takes place between 14- and 16-weeks' gestation (GA14 to 16 weeks). This is a feasibility study, as the perfusion measurements have not yet been performed this early in pregnancy. First the feasibility is assessed, before conducting a full-scale research project. The study will take place in a tertiary care obstetric centre, Máxima Medical Center, in Veldhoven The Netherlands. Measurements will be done at the out patient clinic of obstetrics. Duration of the study is 2 months. This gives ample time for recruitment of the subjects. Recruitment will take place at the outpatient clinic of Máxima Medisch Centrum in Veldhoven. Women with singleton pregnancies coming for their 11-12 weeks' gestational ultrasound, where the pregnancy is dated, will be given a patient information folder in either Dutch or English and asked if the researcher can contact them. Participation is completely on voluntary basis. Patients will be called in the next days by the researcher to answer additional questions and to ask if patients are willing to participate. Contact information of the researchers will be available on the folder in case of questions. Upon inclusion, the patients will be scheduled for a visit to perform all relevant measurements, henceforth referred to as 'measurement day' (MD) which is to take place between 14- and 16-weeks' gestation. The patient, henceforth to be referred to as participant, will be asked to rest for 5 minutes in a supine position. After 5 minutes of rest the blood pressure of the right arm will be measured, three times using the auto-sphygmomanometer. The three measurements will then be used to calculate the average systolic and diastolic blood pressures. After measurement of blood pressure, the ultrasound scan will be performed. The uterine and placental vessels will be measured according to the standard operating procedure attached to this document. All vessels will be measured 3 times during the ultrasound scan.

Official Title
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Placenta Perfusion and Sufficiency Study

Conditions
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Placenta Diseases, Diagnosis, Pregnancy Related, Female, Human

Intervention / Treatment
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* Diagnostic Test: Trans abdominal ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Between 14-16 weeks gestation on measurement day Placenta anterior BMI < 30kg/m2 Ability to give consent Adequate mastery of the Dutch or English languages Exclusion Criteria: Non-intact pregnancy at 13 week's gestational echo. Vanishing twin Multiple gestations Congenital or anatomical anomalies at 13 weeks' gestational echo.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Diagnostic Test: Trans abdominal ultrasound<br>* Ultra sound of the uterus and uterine blood vessels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine blood vessel flow | The feasibility of measuring placenta perfusion between 14-16 weeks of gestation | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uterine vessel differences | To assess whether there are differences in measurements between the two umbilical arteries | Through study completion, an average of 1 year | 
| Relation between uterine vessels | To determine whether a relation between the uterine artery and vein flow exists | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Netherlands, Placenta, Human, Pregnancy, Early pregnancy, Hypertension disorders, Uterus, Uterine artery, Uterine vein, Placental circulation, Placenta physiology, Placenta development