PreeclampsiaNCT06395974
Fetal Renal Artery Doppler in Patients With Preeclampsia
An observational study of Preeclampsia, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- fetal ultrasound
- How many people
- 114 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 15 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: pregnant women with preeclampsia and healthy pregnant women
Who may be able to join
- 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.
- Control:
- Women with healthy pregnancy matched by closest gestational age.
Who cannot join
- ● 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Preeclampsia
- Being tested
- fetal ultrasound
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fetal ultrasoundOther
2D, 3D , Doppler ultrasound
| Study group | Role | What they receive |
|---|---|---|
| preeclampsia | Not described Receives: Other: fetal ultrasound | |
| control | Not described Receives: Other: fetal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
fetal renal artery doppler indices
the difference between the Fetal renal artery Doppler indices between preeclamptic patients and women with healthy pregnancy
Measured: 1 year
Middle cerberal artery doppler indices , Umbilical artery doppler indices and placental volume
Measured: 1 year
Secondary outcomes (1)
neonatal outcome
the ability of Fetal renal artery Doppler in prediction of neonatal complications.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Nov 2024
- Primary completion30 Dec 2025
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousra M. Othman, Assiut University
- Investigators
- Yousra O Mokhtar, Principal investigator, principle investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395974
- Sponsor's protocol ID
- Fetal renal a./preeclampsia
- Status last verified
- May 2026
- First submitted
- 29 Apr 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30656917Mou 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.
PubMed 34716385Rana 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.
PubMed 30920918Stigter 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.
PubMed 11529994Suranyi 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.
PubMed 10805467Nicolaides 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.
PubMed 32171001Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.
PubMed 32443079Azpurua 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.
PubMed 19185102Magee 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.
PubMed 35544388
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06395974
- Acronym / sponsor ID
- Fetal renal a./preeclampsia
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preeclampsia | – | Other: fetal ultrasound |
| control | – | Other: fetal ultrasound |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant women with preeclampsia and healthy pregnant women
Key inclusion criteria (6 listed)
- a) Preeclampsia:
Key exclusion criteria (5 listed)
- ● Multiple pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fetal ultrasound2D, 3D , Doppler ultrasound | Other | control, preeclampsia |
Primary outcome
fetal renal artery doppler indices
Time frame: 1 year
the difference between the Fetal renal artery Doppler indices between preeclamptic patients and women with healthy pregnancy
Middle cerberal artery doppler indices , Umbilical artery doppler indices and placental volume
Time frame: 1 year
1 secondary outcome
neonatal outcome
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 30656917Filipek 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.
- Background: PubMed 34716385Mou 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.
- Background: PubMed 30920918Rana 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.
- Background: PubMed 11529994Stigter 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.
- Background: PubMed 10805467Suranyi 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.
- BackgroundNicolaides K, Giuseppe R, Hecher K, Ximenes R. Doppler in Obstetrics. ISUOG Educational Series, The Fetal Medicine Foundation, 2022.
- Background: PubMed 32171001Ma'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.
- Background: PubMed 32443079Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.
- Background: PubMed 19185102Azpurua 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.
- Background: PubMed 35544388Magee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yousra O Mokhtar principal investigator
principle investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fetal renal artery doppler indices (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06395974, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.