NCT03214393

Brief Summary

Relation of certain maternal serum antibodies to Doppler changes will be studied in cases suffering from hypertension with pregnancy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

July 10, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

12 months

First QC Date

July 10, 2017

Last Update Submit

July 10, 2017

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

  • percentage of cases that develop severe pre-eclampsia

    percentage of cases that develop severe pre-eclampsia will be assessed by an investigator

    It will be calculated after 1 year from the start of the study

Study Arms (1)

Pre-Eclampsia

pregnant women with Pre-Eclampsia will be assessed by serum antibodies and Doppler

Diagnostic Test: DopplerDiagnostic Test: serum antibodies

Interventions

DopplerDIAGNOSTIC_TEST

Doppler will be done to pregnant women with Pre-Eclampsia

Pre-Eclampsia
serum antibodiesDIAGNOSTIC_TEST

serum antibodies will be measured for pregnant women with Pre-Eclampsia

Pre-Eclampsia

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant females 32 weeks gestation or more with pre-eclampsia

You may qualify if:

  • Pregnant women 32 weeks or more gestational age
  • Pre-eclampsia
  • Singleton pregnancy

You may not qualify if:

  • Intrauterine fetal death
  • Fetus with apparent congenital anomalies
  • Pregnant females with other medical disorders
  • History of essential hypertension.
  • History of antepartum hemorrhage.
  • History of rupture of membranes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology

Cairo, Greater Cairo, 11956, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Echocardiography, Doppler

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

EchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyUltrasonography, DopplerHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Doaa Sh Belal, MD

    Cairo U

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doaa Sh Belal, MD

CONTACT

0020223682030doaash@live.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 10, 2017

First Posted

July 11, 2017

Study Start

August 1, 2017

Primary Completion

July 30, 2018

Study Completion

August 30, 2018

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations

EG(1)