P2SS: Placenta Perfusion and Sufficiency Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group 1
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Diagnostic Test: Trans abdominal ultrasound
Ultra sound of the uterus and uterine blood vessels
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Outcome Measures
Primary Outcome Measures
- Uterine blood vessel flow [Through study completion, an average of 1 year]
The feasibility of measuring placenta perfusion between 14-16 weeks of gestation
Secondary Outcome Measures
- uterine vessel differences [Through study completion, an average of 1 year]
To assess whether there are differences in measurements between the two umbilical arteries
- Relation between uterine vessels [Through study completion, an average of 1 year]
To determine whether a relation between the uterine artery and vein flow exists
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years
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Between 14-16 weeks gestation on measurement day
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Placenta anterior
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BMI < 30kg/m2
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Ability to give consent
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Adequate mastery of the Dutch or English languages
Exclusion Criteria:
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Non-intact pregnancy at 13 week's gestational echo.
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Vanishing twin
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Multiple gestations
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Congenital or anatomical anomalies at 13 weeks' gestational echo.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Maxima Medical Center | Veldhoven | Braband | Netherlands |
Sponsors and Collaborators
- Maxima Medical Center
Investigators
- Principal Investigator: Loes Monen, Maxima Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Brosens I, Pijnenborg R, Vercruysse L, Romero R. The "Great Obstetrical Syndromes" are associated with disorders of deep placentation. Am J Obstet Gynecol. 2011 Mar;204(3):193-201. doi: 10.1016/j.ajog.2010.08.009. Epub 2010 Nov 20.
- Fadl S, Moshiri M, Fligner CL, Katz DS, Dighe M. Placental Imaging: Normal Appearance with Review of Pathologic Findings. Radiographics. 2017 May-Jun;37(3):979-998. doi: 10.1148/rg.2017160155.
- Gude NM, Roberts CT, Kalionis B, King RG. Growth and function of the normal human placenta. Thromb Res. 2004;114(5-6):397-407. doi: 10.1016/j.thromres.2004.06.038.
- Mol BWJ, Roberts CT, Thangaratinam S, Magee LA, de Groot CJM, Hofmeyr GJ. Pre-eclampsia. Lancet. 2016 Mar 5;387(10022):999-1011. doi: 10.1016/S0140-6736(15)00070-7. Epub 2015 Sep 2.
- Schiffer V, van Haren A, De Cubber L, Bons J, Coumans A, van Kuijk SM, Spaanderman M, Al-Nasiry S. Ultrasound evaluation of the placenta in healthy and placental syndrome pregnancies: A systematic review. Eur J Obstet Gynecol Reprod Biol. 2021 Jul;262:45-56. doi: 10.1016/j.ejogrb.2021.04.042. Epub 2021 May 4.
- W23.020