Fetal Renal Artery Doppler in Patients With Preeclampsia

Preeclampsia Clinical Trial

Official title:

Fetal Renal Artery Doppler in Patients With Preeclampsia and Its Role in Prediction of Adverse Neonatal Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06395974
• Other study ID #: Fetal renal a./preeclampsia
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: Yousra O Mokhtar
• Phone: +201064990954
• Email: yousramo5tar[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Preeclampsia is a major devastating disorder affects 2:10% of pregnancies worldwide. preeclampsia may be associated with placental insufficiency which may cause fetal blood redistribution to essential organs like brain, heart, kidney.

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 such as kidney which exhibit increased vascular resistance and impaired perfusion. This is in contrast to normal pregnancies near term in which renal vascular resistance falls and increased blood flow to the kidneys is observed. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 31, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Other:
• fetal ultrasound
2D, 3D , Doppler ultrasound

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

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. — View Citation

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. — View Citation

Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nicolaides K, Giuseppe R, Hecher K, Ximenes R. Doppler in Obstetrics. ISUOG Educational Series, The Fetal Medicine Foundation, 2022.

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. Erratum In: Circ Res. 2020 Jan 3;126(1):e8. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fetal renal artery doppler indices	the difference between the Fetal renal artery Doppler indices between preeclamptic patients and women with healthy pregnancy	1 year
Primary	Middle cerberal artery doppler indices , Umbilical artery doppler indices and placental volume		1 year
Secondary	neonatal outcome	the ability of Fetal renal artery Doppler in prediction of neonatal complications.	1 year