Placenta Perfusion and Sufficiency Study

Overview

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.

Study Type

• Study Type: Observational [Patient Registry]
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: December 1, 2023

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.

Interventions

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

Arms, Groups and Cohorts

• Group 1

Clinical Trial Outcome Measures

Primary Measures

• 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 Measures

• uterine vessel differences
  • Time Frame: 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
  • Time Frame: Through study completion, an average of 1 year
  • To determine whether a relation between the uterine artery and vein flow exists

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Maxima Medical Center
• Provider of Information About this Clinical Study
  • Principal Investigator: Sahil Joseph Gregory Manoj Sabnani, Principal Investigator – Maxima Medical Center
• Overall Official(s)
  • Loes Monen, Principal Investigator, Maxima Medical Center

References

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.

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.

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.

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.

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.