CA-125 and Severity of Pre-Eclampsia | NCT02704676

Studies
CA-125 and Severity of Pre-Eclampsia

NCT02704676

Sponsor

Ain Shams Maternity Hospital

Status

Unknown status

Last Update Posted

Mar 18, 2016Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Pre-Eclampsia

Interventions

marker(CA-125)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Jul 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Mar 3, 2016

First Submission Date that Met QC Criteria

Mar 6, 2016

First Posted Date

Mar 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2016

Last Update Posted Date

Mar 18, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Mohamed Bahaa Eldin Ahmed, Clinical professor, Ain Shams Maternity HospitalPrincipal Investigator

Lead Sponsor

Ain Shams Maternity HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Although the source of CA-125 during pregnancy is the fetal chorion, amniotic fluid, and maternal decidua, the perinatal dynamics of maternal serum CA-125 requires clarification. Clinical studies of CA-125 levels and its function in hypertensive pregnant patients are limited and offered contradictory results (Cebesoy et al., 2009).

And so we investigate CA-125 in normal pregnancy and in pre-eclampsia, comparing mild and sever pre-eclampsia to determine relationship of CA-125 and severity of the disease.

Patients will be divided in three groups:

Control: 40 normal healthy pregnant women attending the ER in labor.
Mild pre-eclampsia: 40 patients fulfilling the following criteria.
- Blood pressure: systolic blood pressure >140 and <160 , Diastolic blood pressure >90 and <110
- Proteinuria: 300 mg (+) assessed by urine urignost 3A® (urine strips from DIALAB).
- No symptoms of severity as headache.
- Normal investigations for different organ function (as liver and kidney function).
Severe pre-eclampsia :40 patients fulfilling anyone or more of the following criteria (The American College of Obstetricians and Gynecologists, 2010)(ACOG):
- Systolic blood pressure > 160 mmHg
- Diastolic blood pressure > 110 mmHg (on two occasions at least 6 hours apart while the patient is on bed rest)
- Proteinuria of 5000mg (5g) or higher on a 24-hour urine collection or at least 3+ on two random urine samples collected at least 4 hours apart
- Oliguria < 500 mL urine output in 24 hours
- Cerebral or visual functional disturbances (cns irritability)
- Pulmonary edema or cyanosis (not due to excessive intravenous volume replacement)
- Epigastric or right-upper quadrant abdominal pain
- Impaired liver function on laboratory analysis (elevated aspartate aminotransferase (AST), alanine amino transferase(ALT), or lactate dehydrogenase(LDH))
- Thrombocytopenia (platelet count < 150,000/uL)
- Fetal growth restriction.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
marker(CA-125)	Other	measuring CA-125 in pregnant women (normal,mild and sever pre-eclampsia)	control patients mild pre-eclampsia sever pre-eclampsia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
increase serum CA-125 in pre-eclamptic patients	measuring serum CA-125	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marwa M Ibrahim, MBBCH	Contact	01007378387		dr.marwa_2010@yahoo.com
Ahmed M Bahaa eldin, A.Professor	Contact	+20 1111700556		abahaa0503@med.asu.edu.eg

Overall Officials

Name	Affiliation	Role
Hassan Tawfek, Pofessor	ain-shams university , cairo	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19437230	Background	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.

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases