- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06395974
Fetal Renal Artery Doppler in Patients With Preeclampsia
Fetal Renal Artery Doppler and Three Dimensional Power Doppler Study of Placenta in Patients With Preeclampsia and Its Role in Prediction of Adverse Neonatal Outcomes
Study Overview
Detailed Description
Preeclampsia is a major devastating medical condition that affects pregnant women after 20 weeks of pregnancy. It affects 2:10% of pregnancies worldwide according to World Health Organisation with higher incidence in developing countries.
Vascular endothelial dysfunction due to abnormal placentation is believed to be the main cause of multi-organ failure and uteroplacental insufficiency that occur in preeclampsia leading to major adverse effects in both mother and fetus.
Placental insufficiency causes a redistribution of fetal blood to essential organs ; brain, heart and adrenal glands by decreasing their vascular resistance on expense of peripheral organs. Changes occur in fetal renal circulation in preeclampsia is still area of debate with conflicting results in literature. Doppler ultrasound examination of vasculature of selected organs such as kidneys may have a role in detection of hemodynamic rearrangements that occur in cases of placental insufficiency and preeclampsia.
Also, Three dimensional power Doppler plays a role in comprehensive analysis of placental perfusion. It has a promising results regarding prediction of preeclampsia during early pregnancy and may have insights into prediction of adverse neonatal outcomes in late trimester.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Asyut, Egypt
- Assiut University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
a) Preeclampsia:
- Women with preeclampsia >28 weeks of pregnancy.
- Singleton pregnancy.
Women with intrauterine growth restriction and abnormal amniotic fluid volume to simulate real world data.
b) Control:
- Women with healthy pregnancy matched by closest gestational age.
Exclusion Criteria:
● Multiple pregnancy.
- Known Congenital fetal malformations.
- Women with other comorbidity such as ischemic heart disease, DM, Autoimmune disorders, kidney disease, neurological disorders, liver or haematological disorders.
- Women unable to provide informed consent.
- Women who refuse to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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control
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2D, 3D , Doppler ultrasound
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preeclampsia
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2D, 3D , Doppler ultrasound
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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fetal renal artery doppler indices
Time Frame: 1 year
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the difference between the Fetal renal artery Doppler indices between preeclamptic patients and women with healthy pregnancy
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1 year
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Middle cerberal artery doppler indices , Umbilical artery doppler indices and placental volume
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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neonatal outcome
Time Frame: 1 year
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the ability of Fetal renal artery Doppler in prediction of neonatal complications.
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yousra O Mokhtar, principle investigator
Publications and helpful links
General Publications
- Stigter RH, Mulder EJ, Bruinse HW, Visser GH. Doppler studies on the fetal renal artery in the severely growth-restricted fetus. Ultrasound Obstet Gynecol. 2001 Aug;18(2):141-5. doi: 10.1046/j.1469-0705.2001.00493.x.
- Azpurua H, Dulay AT, Buhimschi IA, Bahtiyar MO, Funai E, Abdel-Razeq SS, Luo G, Bhandari V, Copel JA, Buhimschi CS. Fetal renal artery impedance as assessed by Doppler ultrasound in pregnancies complicated by intraamniotic inflammation and preterm birth. Am J Obstet Gynecol. 2009 Feb;200(2):203.e1-11. doi: 10.1016/j.ajog.2008.11.001.
- Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.
- Filipek A, Jurewicz E. [Preeclampsia - a disease of pregnant women]. Postepy Biochem. 2018 Dec 29;64(4):232-229. doi: 10.18388/pb.2018_146. Polish.
- Mou AD, Barman Z, Hasan M, Miah R, Hafsa JM, Das Trisha A, Ali N. Prevalence of preeclampsia and the associated risk factors among pregnant women in Bangladesh. Sci Rep. 2021 Oct 29;11(1):21339. doi: 10.1038/s41598-021-00839-w.
- Suranyi A, Streitman K, Pal A, Nyari T, Retz C, Foidart JM, Schaaps JP, Kovacs L. Fetal renal artery flow and renal echogenicity in the chronically hypoxic state. Pediatr Nephrol. 2000 May;14(5):393-9. doi: 10.1007/s004670050781.
- Nicolaides K, Giuseppe R, Hecher K, Ximenes R. Doppler in Obstetrics. ISUOG Educational Series, The Fetal Medicine Foundation, 2022.
- Ma'ayeh M, Krishnan V, Gee SE, Russo J, Shellhaas C, Rood KM. Fetal renal artery impedance in pregnancies affected by preeclampsia. J Perinat Med. 2020 Mar 14:/j/jpme.ahead-of-print/jpm-2020-0024/jpm-2020-0024.xml. doi: 10.1515/jpm-2020-0024. Online ahead of print.
- Magee LA, Nicolaides KH, von Dadelszen P. Preeclampsia. N Engl J Med. 2022 May 12;386(19):1817-1832. doi: 10.1056/NEJMra2109523. No abstract available.
- Rana S, Lemoine E, Granger JP, Karumanchi SA. Preeclampsia: Pathophysiology, Challenges, and Perspectives. Circ Res. 2019 Mar 29;124(7):1094-1112. doi: 10.1161/CIRCRESAHA.118.313276.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fetal renal a./preeclampsia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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