An interventional study of Assessment of maternal hemodynamics in Hypertensive Disorders of Pregnancy (HDP) and Pregnancy, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 4 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
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Among 18 studies in Hypertension by Assistance Publique - Hôpitaux de Paris — 6 open to participants now, 6 under way, none of them phase 3. Hypertension · Assistance Publique - Hôpitaux de Paris.
Among the 18 studies in Hypertension by Assistance Publique - Hôpitaux de Paris, this one is the 7th largest by planned enrollment of the 12 interventional ones that give a count, is one of 4 that started in 2026, is one of 10 with no phase, and was the 18th registered.
6,118 studies on the registry are indexed under Hypertension; 914 are open to participants now.
Browse Hypertension studies →6 of the 18 studies in Hypertension by Assistance Publique - Hôpitaux de Paris are open now, in 1 country. Recruiting first, the newest first:
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18–85
Assistance Publique - Hôpitaux de Paris
Ages 18+
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+ · Men only
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18–90
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
By country, each count listing its studies:
Of the 562 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (36%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
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18 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above the median of 100 across 4,579 interventional studies indexed under Hypertension.
Median enrollment 210 across the 12 interventional studies, 160 across the 6 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.
2 of the studies in Hypertension by Assistance Publique - Hôpitaux de Paris that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07675434Assistance Publique - Hôpitaux de ParisProspective Cohort of Acute Cardiology Referrals in an Ambulatory Day-Hospital Setting | 2027-02-01 |
| NCT05917600Assistance Publique - Hôpitaux de ParisImpact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control | 2027-06 |
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Among the 18 studies in Hypertension by Assistance Publique - Hôpitaux de Paris, from their registry updates:
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Carotid ultrasound-based assessment of maternal hemodynamics to guide HYpertension treatment in PREgnancy - Pilot study - CHYPRE-pilot Healthy pregnancy is associated with significant physiological hemodynamic changes that are critical for maternal adaptation and health. Insufficient adaptive changes can lead to pregnancy disorders such as preeclampsia. Hypertensive disorders of pregnancy (HDP) are a leading cause of maternal and foetal morbidity and mortality. Assessment of maternal hemodynamic alterations can improve management strategies by better risk stratification of pregnant women. Current methods for maternal hemodynamic measurement involve transthoracic echocardiography, requiring expert consultation with a cardiologist and highly trained staff. Simpler techniques like carotid ultrasound based hemodynamic assessment can potentially provide an easy-to perform alternative, requiring minimal training.
Aims and objectives of the study Main objective: 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.
Primary endpoint: The agreement between carotid ultrasound and echocardiography to classify individuals with very high (>1300 dynes.s.cm-5) vs not high (=\<1300 dynes.s.cm-5) PVR the day of inclusion. The area under the receiver operating characteristic (AUROC) curve, sensitivity and specificity of carotid ultrasound to identify very high PVR will be calculated.
Secondary objectives:
Exploratory objectives:
Secondary endpoints:
Exploratory endpoints:
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Exclusion criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
We will recruit pregnant women (\>18 years of age) between 10-40th week of pregnancy. The study design will be cross-sectional with a total recruitment 200 pregnant women, during routine clinical visits.The element under investigation in this study is the use of carotid ultrasound-derived hemodynamic measurements as a surrogate for CO and PVR assessed by transthoracic echocardiography (TTE) in pregnant women.
Diagnostic Test: Assessment of maternal hemodynamics
Carotid ultrasound and echocardiography will be performed by an expert operator in all participants for comparison with echocardiography. In all participants, a novice operator will also perform carotid ultrasound to assess inter-operator agreement.
Main objective
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.
Time frame: At inclusion visit
Evaluation of the agreement between PVR measurements obtained by echocardiography and carotid ultrasound as continuous variables.
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.
Time frame: At inclusion visit
Evaluation of the agreement between cardiac output (CO)measurements obtained by echocardiography and carotid ultrasound as continuous variables.
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.
Time frame: At inclusion visit
Evaluation of the inter-operator agreement and variability in carotid ultrasound measurement of PVR between an expert operator and a novice operator.
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.
Time frame: At inclusion visit
Evaluation of the inter-operator agreement and variability in carotid ultrasound measurement of CO between an expert operator and a novice operator.
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.
Time frame: At inclusion visit
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.
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.
Time frame: From inclusion visit, up to 7 months maximum (date of delivery)
Investigation of whether the agreement between the PVR obtained by echocardiography and carotid ultrasound is acceptable in both healthy and pathological pregnancies.
Absence of significant bias in the Bland-Altman analysis both in healthy and pathological pregnancies.
Time frame: At inclusion visit
Evaluation of the usability of carotid ultrasound in routine maternity setting.
Mean group score from the post experience usability questionnaire
Time frame: At inclusion visit
Plan to share: Yes — Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Supporting information: Study protocol, Informed consent form
Time frame: Two years after the last publication
Access criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 13 months is below that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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