NCT06395974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

April 29, 2024

Last Update Submit

May 6, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • fetal renal artery doppler indices

    the difference between the Fetal renal artery Doppler indices between preeclamptic patients and women with healthy pregnancy

    1 year

  • Middle cerberal artery doppler indices , Umbilical artery doppler indices and placental volume

    1 year

Secondary Outcomes (1)

  • neonatal outcome

    1 year

Study Arms (2)

preeclampsia

Other: fetal ultrasound

control

Other: fetal ultrasound

Interventions

2D, 3D , Doppler ultrasound

controlpreeclampsia

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

pregnant women with preeclampsia and healthy pregnant women

You may qualify if:

  • 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.

You may not qualify if:

  • ● 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, Egypt

Location

Related Publications (10)

  • 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.

    PMID: 30656917BACKGROUND
  • 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.

    PMID: 34716385BACKGROUND
  • 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.

    PMID: 30920918BACKGROUND
  • 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.

    PMID: 11529994BACKGROUND
  • 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.

    PMID: 10805467BACKGROUND
  • Nicolaides K, Giuseppe R, Hecher K, Ximenes R. Doppler in Obstetrics. ISUOG Educational Series, The Fetal Medicine Foundation, 2022.

    BACKGROUND
  • 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.

    PMID: 32171001BACKGROUND
  • Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.

    PMID: 32443079BACKGROUND
  • 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.

    PMID: 19185102BACKGROUND
  • 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.

    PMID: 35544388BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Yousra O Mokhtar

    principle investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 2, 2024

Study Start

November 1, 2024

Primary Completion

December 30, 2025

Study Completion

February 15, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations