Placenta Perfusion and Sufficiency Study

Pregnancy Related Clinical Trial

— P2SS  

Official title:

Placenta Perfusion and Sufficiency Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06042348
• Other study ID #: W23.020
• Status: Recruiting
• Start date: September 15, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: September 2023
• Source: Maxima Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 31, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Female
• Human
• Placenta Diseases
• Pregnancy Related

Intervention

Diagnostic Test:
• Trans abdominal ultrasound
Ultra sound of the uterus and uterine blood vessels

Locations

Country	Name	City	State
Netherlands	Maxima Medical Center	Veldhoven	Braband

Sponsors (1)

Lead Sponsor	Collaborator
Maxima Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	uterine vessel differences	To assess whether there are differences in measurements between the two umbilical arteries	Through study completion, an average of 1 year
Secondary	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