Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
30 August 2021 |
Main ID: |
NCT03111576 |
Date of registration:
|
07/04/2017 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Vascular Changes in Pre-Eclamptic Patients and Its Impact on Pregnancy Outcome.
PE |
Scientific title:
|
Assessment ofMaternal and FetalVascular Changes inNormotensive andPre-Eclamptic Patients and Its Impact on Pregnancy Outcome. |
Date of first enrolment:
|
May 31, 2017 |
Target sample size:
|
100 |
Recruitment status: |
Recruiting |
URL:
|
https://clinicaltrials.gov/show/NCT03111576 |
Study type:
|
Observational |
Study design:
|
|
Phase:
|
|
|
Countries of recruitment
|
Egypt
| | | | | | | |
Contacts
|
Name:
|
Nesreen A Shehata, MD |
Address:
|
|
Telephone:
|
00201024150605 |
Email:
|
nesoomar@yahoo.com |
Affiliation:
|
|
|
Name:
|
Nesreen AFattah Shehata, MD |
Address:
|
|
Telephone:
|
00201024150605 |
Email:
|
nesoomar@yahoo.com |
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. All women will be :
- Nonsmokers,
- Nondiabetic,
- With no family history of vascular diseases.
2. Gestational age at enrolment >28 and <34 weeks of gestation.
3. Singleton pregnancy.
4. Informed consent.
5. 50 Normotensive pregnant women without complications will be defined as controls.
6. 50 Pre-eclamptic patients.
Exclusion Criteria:
- 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.
Age minimum:
20 Years
Age maximum:
40 Years
Gender:
Female
|
Health Condition(s) or Problem(s) studied
|
Pre-Eclampsia
|
Primary Outcome(s)
|
Vascular changes by Doppler imaging
[Time Frame: >28-<34 weeks]
|
Secondary Outcome(s)
|
Pregnancy outcome
[Time Frame: Date of delivery and within 40 days after delivery]
|
Secondary ID(s)
|
Beni-Suef 11
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|