Pregnancy Related Clinical Trial
— P2SSOfficial title:
Placenta Perfusion and Sufficiency Study
Verified date | September 2023 |
Source | Maxima Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maxima Medical Center | Veldhoven | Braband |
Lead Sponsor | Collaborator |
---|---|
Maxima Medical Center |
Netherlands,
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
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 |
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