NCT02704676

Brief Summary

The Aim of this study is to determine the relationship between serum concentrations of cancer antigen-125 (CA-125) and pre-eclampsia severity.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

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

Study Start

First participant enrolled

March 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 18, 2016

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

March 3, 2016

Last Update Submit

March 17, 2016

Conditions

Pre-Eclampsia

Keywords

CA-125Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

  • increase serum CA-125 in pre-eclamptic patients

    measuring serum CA-125

    1 year

Study Arms (3)

control patients

normal pregnant women, 3rd trimester

Other: marker(CA-125)

mild pre-eclampsia

patients with albuminuria +1 and blood pressure \>140/90 and \<160/110

Other: marker(CA-125)

sever pre-eclampsia

patients diagnosed as sever pre-eclampsia according to criteria done by ACOG

Other: marker(CA-125)

Interventions

marker(CA-125)OTHER

measuring CA-125 in pregnant women (normal,mild and sever pre-eclampsia)

control patientsmild pre-eclampsiasever pre-eclampsia

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population comprises pregnant women once diagnosed pre-eclampsia, attending to Ain Shams University Maternity Hospital, or for antinatal care of the corrosponding gestational age.

You may qualify if:

  • pregnant women 3rd trimester
  • any age
  • medically free at least by history
  • signs and or symptoms of pre-eclampsia

You may not qualify if:

  • Other causes elevate CA-125 as: ovarian cancer, endometrial cancer, breast cancer and benign conditions as: endometriosis and liver cirrhosis.
  • Chronic hypertension
  • Diabetes Mellitus (DM)
  • Liver diseases
  • Thyroid disorders
  • Kidney diseases
  • Cardiac diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cebesoy FB, Balat O, Dikensoy E, Kalayci H, Ibar Y. CA-125 and CRP are elevated in preeclampsia. Hypertens Pregnancy. 2009 May;28(2):201-11. doi: 10.1080/10641950802601187.

    PMID: 19437230BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hassan Tawfek, Pofessor

    ain-shams university , cairo

    STUDY DIRECTOR

Central Study Contacts

Marwa M Ibrahim, MBBCH

CONTACT

01007378387dr.marwa_2010@yahoo.com

Ahmed M Bahaa eldin, A.Professor

CONTACT

+20 1111700556abahaa0503@med.asu.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 10, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

March 18, 2016

Record last verified: 2016-03