Pre-EclampsiaPENCT03111576
Vascular Changes in Pre-Eclamptic Patients and Its Impact on Pregnancy Outcome.
An observational study of Pre-Eclampsia, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Normal pregnancy is associated with vasodilation and decreased peripheral resistance, which is detected as early as 5 weeks' gestation . Pre-eclampsia is a multi-system disorder of the second half of pregnancy , which is characterized by increased vascular reactivity and peripheral resistance with pathological changes… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Pre-Eclampsia
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 31 May 2017to Dec 2021
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: on 50 normotensive pregnant women and 50 Pre-eclamptic patients will attend the antenatal clinic in the obstetric ward in the department of Obstetrics and Gynecology in Benisuef general hospital.
Who may be able to join
- All women will be :
- Nonsmokers,
- Nondiabetic,
- With no family history of vascular diseases.
- Gestational age at enrolment >28 and <34 weeks of gestation.
- Singleton pregnancy.
Show all 9Show fewer
- Informed consent.
- 50 Normotensive pregnant women without complications will be defined as controls.
- 50 Pre-eclamptic patients.
Who cannot join
- 1. Patients who presented to labor and delivery were excluded as subjects. 2. Growth-restricted fetus due to:
- marginal insertion of the umbilical cord,
- placental infarction,
- fetal minor heart anomaly,
- Fetal viral infection. 3. Refusal of patient to participate in the study. 4. Multiple gestations. 5. Autoimmune diseases 6. Previous history of PE or IUGR.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Nesreen Abdel Fattah Abdullah Shehata
Cairo
Nesreen AFattah Shehata, MD, 00201024150605, nesoomar@yahoo.com
Hamada Ashry Abdel wahed, MD, 01007240754, Hamadaashry2010@yahool.com
About this study
Official title: Assessment ofMaternal and FetalVascular Changes inNormotensive andPre-Eclamptic Patients and Its Impact on Pregnancy Outcome.
Normal pregnancy is associated with vasodilation and decreased peripheral resistance, which is detected as early as 5 weeks' gestation .
Pre-eclampsia is a multi-system disorder of the second half of pregnancy , which is characterized by increased vascular reactivity and peripheral resistance with pathological changes that are consistent with impaired blood flow to the affected vascular beds. Investigators will evaluate fetal and maternal vascular changes in normotensive and pre-eclamptic patients by Ultrasound and Doppler and their impact on prediction of pregnancy outcome.
Read the detailed description
Pre-eclampsia affects 2-8% of all pregnancies, although treatment is generally effective. However, 10-15% of direct maternal deaths are associated with Pre-eclampsia and eclampsia(WHO, 2011). There is a considerable evidence that generalized endothelial dysfunction underlies the clinical manifestations of the disease (Oladipupo et al., 2014).
It has been demonstrated that peripheral nutritive blood flow is impaired in pregnancies complicated by pre-eclampsia and precedes onset of the disorder (Kenny et al., 2014).
The pathophysiological mechanism is characterized by a failure of the trophoblastic invasion of the spiral arteries which may be associated with an increased vascular resistance of the uterine artery and a decreased perfusion of placenta. (Al-Jameil et al ; 2014 ) Ultrasound of the brachial artery, and Doppler ultrasound of the carotid artery and uterine artery are propaedeutic , non-invasive methods that contribute to the understanding of the pathophysiology of PE and Eclampsia (Takata et al., 2002 ).
Doppler assessment of the placental circulation plays an important role in screening for impaired placentation and its complications of preeclampsia, intrauterine growth restriction and perinatal death. Assessment of the fetal circulation is essential in the better understanding of the pathophysiology of a wide range of pathological pregnancies and their clinical management(Ghidini \& Vergani, 2012).
- Conditions
- Pre-Eclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normotensive | This group will include 50 pregnant women with normal blood pressure between 28 and 34 weeks. | |
| Pre-eclamptic | This group will include 50 pregnant women with diagnosis of pre-eclampsia between 28 and 34 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular changes by Doppler imaging
Doppler imaging will be undertaken for assessing fetal umbilical, middle cerebral arteries in addition to ductus venosus. Concerning maternal vessel assessment, Doppler will be done for uterine arteries, common carotid and brachial arteries.
Measured: >28-<34 weeks
Secondary outcomes (1)
Pregnancy outcome
Maternal delivery mode and any complications together with fetal growth restriction or neonatal complications.
Measured: Date of delivery and within 40 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start31 May 2017
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111576
- Sponsor's protocol ID
- Beni-Suef 11
- Acronym
- PE
- Status last verified
- Aug 2021
- First submitted
- 7 Apr 2017
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment ofMaternal and FetalVascular Changes inNormotensive andPre-Eclamptic Patients and Its Impact on Pregnancy Outcome.
- ClinicalTrials.gov ID
- NCT03111576
- Acronym / sponsor ID
- PE / Beni-Suef 11
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 Apr 2017 (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.
Normal pregnancy is associated with vasodilation and decreased peripheral resistance, which is detected as early as 5 weeks' gestation .
Pre-eclampsia is a multi-system disorder of the second half of pregnancy , which is characterized by increased vascular reactivity and peripheral resistance with pathological changes that are consistent with impaired blood flow to the affected vascular beds. Investigators will evaluate fetal and maternal vascular changes in normotensive and pre-eclamptic patients by Ultrasound and Doppler and their impact on prediction of pregnancy outcome.
Detailed description
Pre-eclampsia affects 2-8% of all pregnancies, although treatment is generally effective. However, 10-15% of direct maternal deaths are associated with Pre-eclampsia and eclampsia(WHO, 2011). There is a considerable evidence that generalized endothelial dysfunction underlies the clinical manifestations of the disease (Oladipupo et al., 2014).
It has been demonstrated that peripheral nutritive blood flow is impaired in pregnancies complicated by pre-eclampsia and precedes onset of the disorder (Kenny et al., 2014).
The pathophysiological mechanism is characterized by a failure of the trophoblastic invasion of the spiral arteries which may be associated with an increased vascular resistance of the uterine artery and a decreased perfusion of placenta. (Al-Jameil et al ; 2014 ) Ultrasound of the brachial artery, and Doppler ultrasound of the carotid artery and uterine artery are propaedeutic , non-invasive methods that contribute to the understanding of the pathophysiology of PE and Eclampsia (Takata et al., 2002 ).
Doppler assessment of the placental circulation plays an important role in screening for impaired placentation and its complications of preeclampsia, intrauterine growth restriction and perinatal death. Assessment of the fetal circulation is essential in the better understanding of the pathophysiology of a wide range of pathological pregnancies and their clinical management(Ghidini \& Vergani, 2012).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normotensive | – | –This group will include 50 pregnant women with normal blood pressure between 28 and 34 weeks. |
| Pre-eclamptic | – | –This group will include 50 pregnant women with diagnosis of pre-eclampsia between 28 and 34 weeks. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- on 50 normotensive pregnant women and 50 Pre-eclamptic patients will attend the antenatal clinic in the obstetric ward in the department of Obstetrics and Gynecology in Benisuef general hospital.
Key inclusion criteria (9 listed)
- All women will be :
- Gestational age at enrolment >28 and <34 weeks of gestation.
- Singleton pregnancy.
- Informed consent.
- 50 Normotensive pregnant women without complications will be defined as controls.
Key exclusion criteria (5 listed)
- 1. Patients who presented to labor and delivery were excluded as subjects. 2. Growth-restricted fetus due to:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vascular changes by Doppler imaging
Time frame: >28-<34 weeks
Doppler imaging will be undertaken for assessing fetal umbilical, middle cerebral arteries in addition to ductus venosus. Concerning maternal vessel assessment, Doppler will be done for uterine arteries, common carotid and brachial arteries.
1 secondary outcome
Pregnancy outcome
Time frame: Date of delivery and within 40 days after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Pre-Eclampsia
Active, not recruitingEarly Phase 1
Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
Preeclampsia Postpartum
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Active, not recruitingEarly Phase 1
Daily Aspirin Treatment After Preeclampsia
Preeclampsia
RecruitingEarly Phase 1
Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia
Preeclampsia, Endothelial Function
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Hypertensive Disorders of Pregnancy, Preeclampsia
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.
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 Pre-Eclampsia, run by Beni-Suef 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 9 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: status not confirmed, as of the sponsor's last update on 18 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nesreen A Shehata, MD (00201024150605, nesoomar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular changes by Doppler imaging (time frame: >28-<34 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2021.