Carotid Ultrasound-based Assessment of Maternal Hemodynamics to Guide HYpertension Treatment in PREgnancy - Pilot Study
NCT07932171, Not applicable, Not yet recruiting, Assistance Publique - Hôpitaux de Paris
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Carotid Ultrasound-based Assessment of Maternal Hemodynamics to Guide HYpertension Treatment in PREgnancy - Pilot Study | ClinicalTrials.gov |
| NCT number | NCT07932171 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 200 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris | ClinicalTrials.gov |
| Conditions | Hypertensive Disorders of Pregnancy (HDP), Pregnancy | ClinicalTrials.gov |
| Interventions | Assessment of maternal hemodynamics | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Main objective | At inclusion visit | To evaluate the accuracy of carotid-ultrasound for classifying individuals with very high peripheral vascular resistance (PVR) or not very high PVR during pregnancy, using echocardiography as the standard reference, both performed by an expert operator. | ClinicalTrials.gov |
| Secondary | Evaluation of the agreement between PVR measurements obtained by echocardiography and carotid ultrasound as continuous variables. | At inclusion visit | Bland Altman analysis to evaluate the agreement between echocardiography and carotid ultrasound-based estimation of PVR on a continuous scale. Mean differences and bias will be calculated. | ClinicalTrials.gov |
| Secondary | Evaluation of the agreement between cardiac output (CO)measurements obtained by echocardiography and carotid ultrasound as continuous variables. | At inclusion visit | Bland Altman analysis to evaluate the agreement between echocardiography and carotid ultrasound-based estimation of PVR on a continuous scale. Mean differences and bias will be calculated. | ClinicalTrials.gov |
| Secondary | Evaluation of the inter-operator agreement and variability in carotid ultrasound measurement of PVR between an expert operator and a novice operator. | At inclusion visit | Inter-operator variability between expert and novice operator for carotid ultrasound-based PVR measurement using Bland-Altman analysis and Intraclass Correlation Coefficient (ICC) will be performed. | ClinicalTrials.gov |
| Secondary | Evaluation of the inter-operator agreement and variability in carotid ultrasound measurement of CO between an expert operator and a novice operator. | At inclusion visit | Inter-operator variability between expert and novice operator for carotid ultrasound-based PVR measurement using Bland-Altman analysis and Intraclass Correlation Coefficient (ICC) will be performed. | ClinicalTrials.gov |
| Other | Evaluation of whether pregnant women with very high (>1300 dynes.s.cm-5) PVR during pregnancy (defined using carotid ultrasound) have a higher incidence of adverse pregnancy outcomes (preeclampsia or pre-term birth) compared to pregnant women without. | From inclusion visit, up to 7 months maximum (date of delivery) | Single clinically adverse pregnancy outcome defined as incidence of either preeclampsia or pre-term birth - Yes/No Association with PVR tested using multivariable logistic regression. | ClinicalTrials.gov |
| Other | Investigation of whether the agreement between the PVR obtained by echocardiography and carotid ultrasound is acceptable in both healthy and pathological pregnancies. | At inclusion visit | Absence of significant bias in the Bland-Altman analysis both in healthy and pathological pregnancies. | ClinicalTrials.gov |
| Other | Evaluation of the usability of carotid ultrasound in routine maternity setting. | At inclusion visit | Mean group score from the post experience usability questionnaire | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)