Clinical trial NCT06395974: Fetal Renal Artery Doppler in Patients With Preeclampsia
Official title: Fetal Renal Artery Doppler in Patients With Preeclampsia and Its Role in Prediction of Adverse Neonatal Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preeclampsia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 88
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women with preeclampsia and healthy pregnant women

Brief 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: fetal renal artery doppler indices
timeFrame: 1 year
measure: Middle cerberal artery doppler indices , Umbilical artery doppler indices and placental volume
timeFrame: 1 year
Secondary outcomes:
measure: neonatal outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
affiliation: principle investigator
name: Yousra O Mokhtar
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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.
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citation: Nicolaides K, Giuseppe R, Hecher K, Ximenes R. Doppler in Obstetrics. ISUOG Educational Series, The Fetal Medicine Foundation, 2022.
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.
citation: Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.
citation: 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.
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.