NCT06042348

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

August 31, 2023

Last Update Submit

September 11, 2023

Conditions

Placenta Diseases, DiagnosisPregnancy RelatedFemaleHuman

Keywords

PlacentaHumanPregnancyEarly pregnancyHypertension disordersUterusUterine arteryUterine veinPlacental circulationPlacenta physiologyNetherlandsPlacenta development

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • uterine vessel differences

    Through study completion, an average of 1 year

  • Relation between uterine vessels

    Through study completion, an average of 1 year

Study Arms (1)

Group 1

Diagnostic Test: Trans abdominal ultrasound

Interventions

Trans abdominal ultrasoundDIAGNOSTIC_TEST

Ultra sound of the uterus and uterine blood vessels

Group 1

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The base population are women with singleton pregnancies between 14- and 16 weeks' gestation.

You may qualify if:

  • 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

You may not qualify if:

  • Non-intact pregnancy at 13 week's gestational echo.
  • Vanishing twin
  • Multiple gestations
  • Congenital or anatomical anomalies at 13 weeks' gestational echo.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maxima Medical Center

Veldhoven, Braband, Netherlands

RECRUITING

Related Publications (5)

  • 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.

    PMID: 15507270BACKGROUND

  • 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.

    PMID: 28493802BACKGROUND

  • 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.

    PMID: 21094932BACKGROUND

  • 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.

    PMID: 33984727BACKGROUND

  • 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.

    PMID: 26342729BACKGROUND

MeSH Terms

Conditions

Placenta DiseasesDisease

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Loes Monen

    Maxima Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 18, 2023

Study Start

September 15, 2023

Primary Completion

December 1, 2023

Study Completion

January 31, 2024

Last Updated

September 18, 2023

Record last verified: 2023-09

Locations

NL(1)