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Clinical Trials/NCT06042348
NCT06042348
Recruiting
Not Applicable

Placenta Perfusion and Sufficiency Study

Maxima Medical Center1 site in 1 country10 target enrollmentStarted: September 15, 2023Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Maxima Medical Center
Enrollment
10
Locations
1
Primary Endpoint
Uterine blood vessel flow

Overview

Brief Summary

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

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Uterine blood vessel flow

Time Frame: Through study completion, an average of 1 year

The feasibility of measuring placenta perfusion between 14-16 weeks of gestation

Secondary Outcomes

  • Relation between uterine vessels(Through study completion, an average of 1 year)
  • uterine vessel differences(Through study completion, an average of 1 year)

Investigators

Sponsor
Maxima Medical Center
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sahil Joseph Gregory Manoj Sabnani

Principal Investigator

Maxima Medical Center

Study Sites (1)

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