Vascular Changes in Pre-Eclamptic Patients and Its Impact on Pregnancy Outcome.

NCT03111576 | Unknown DMC

• 1 other identifier: Beni-Suef 11
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

• 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.

  >28-<34 weeks

Secondary Outcomes (1)

• Pregnancy outcome

  Date of delivery and within 40 days after delivery

Study Arms (2)

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.

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.
• Informed consent.
• Normotensive pregnant women without complications will be defined as controls.
• Pre-eclamptic patients.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Nesreen Abdel Fattah Abdullah Shehata

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Nesreen A Shehata, MD

CONTACT

00201024150605; nesoomar@yahoo.com

Hamada A Abd el Wahed, MD

CONTACT

01007240754; hamadaashry2010@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 13, 2017
• Study Start: May 31, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)