Preeclampsia and Intrauterine Growth Restriction Clinical Trial
Official title:
Placental Insufficiency Microcirculation Quantification by Ultrafast Doppler: an Observational Prospective Study
| NCT number | NCT03860103 |
| Other study ID # | RC19_0049 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 1, 2019 |
| Est. completion date | March 16, 2022 |
| Verified date | March 2022 |
| Source | Nantes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
To identify fetuses small for their gestational-age who have reached their appropriate growth potential from growth-restricted fetuses due to placental insufficiency is uneasy. Intra Uterine Growth Restriction (IUGR) increases the risk for indicated preterm delivery, neonatal mortality and morbidity. Therefore, improving the knowledge of the placental perfusion is essential to better identify and manage fetal chronic oxygen deprivation associated with placental insufficiency. Thus, the investigators propose to study placental microcirculation with a more efficient Doppler than conventional Doppler use in clinical practice. The Ultrafast Doppler is being able to map placental blood flow and could have potential impact in placental insufficiency diagnosis and prevention. Moreover, this Doppler could discriminate maternal and fetal vascularization. The hypothesis is that Ultrafast Doppler could help clinician to diagnose and manage preeclampsia and IUGR during pregnancy.
| Status | Completed |
| Enrollment | 165 |
| Est. completion date | March 16, 2022 |
| Est. primary completion date | March 16, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 60 Years |
| Eligibility | Inclusion Criteria: - Patient who accepted to participate in the study - Woman over 18 years old - Affiliated to a social security scheme - Mono-fetal pregnancy - Patients with normal pregnancy between 11 and 42 weeks of amenorrhea - Patients hospitalized for preeclampsia and / or intrauterine growth retardation, beyond 20 weeks of amenorrhea Exclusion Criteria: - Minors, adults under guardianship, protected persons - Not affiliated to a social security scheme - Multiple pregnancy |
| Country | Name | City | State |
|---|---|---|---|
| France | Nantes University Hospital | Nantes |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Qualitative analysis (velocities) of intraplacental blood flow after acquisition of sequences in Ultrafast Doppler imaging | from the 12 week of gestation | ||
| Primary | Quantitative analysis (flow rates) of intraplacental blood flow after acquisition of sequences in Ultrafast Doppler | from the 12 week of gestation |