NCT01518816

Brief Summary

The aim of this study is to detect the association between maternal serum antioxidant level and preterm labor.

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
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2011

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 30, 2012

Status Verified

January 1, 2012

Enrollment Period

6 months

First QC Date

January 24, 2012

Last Update Submit

January 26, 2012

Conditions

Preterm Labor

Keywords

antioxidant preterm labor

Study Arms (2)

preterm labor cases

Group A: 35 pregnant women diagnosed with preterm labor(Preterm labor pain at least 3 contraction every 20 minutes ,cervical dilatation \< 2cm and effacement\< 50%) which will deliver within one week maximum after hospitalization.

control group

Group B: 35 pregnant women( controls )with uncomplicated pregnancies at a similar gestational ages followed routinely in the antenatal care unit.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

pregnant women attending the outpatient obstetric clinic and inpatient of Obstetrics and Gynecology department or when they will be admitted to the delivary room of Ain Shams university hospital.

You may qualify if:

  • Preterm labor(pregnant between 28th and 37th week).
  • Singleton pregnancy.
  • Amnion membranes were intact

You may not qualify if:

  • Past history of preterm labor or premature delivery.
  • Urinary tract infections and any other infections.
  • Poly- or oligohydramnios.
  • Fetal distress, fetal or uterine anomaly.
  • Membranes rupture and placenta pathology.
  • Preeclampsia or intrauterine growth retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Tertiary, Egypt

RECRUITING

Biospecimen

Retention: NONE RETAINED

serum

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • ABDALLAH s ABDELATIF, residant

    Ain Shams Maternity Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed SE elsafty, lecturer

CONTACT

01003922211

Ahmed M Ibrahim, ass proff

CONTACT

01223416828abugooda@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
THE ROLE OF SERUM TOTAL ANTI OXIDANT IN PRETERM LABOR

Study Record Dates

First Submitted

January 24, 2012

First Posted

January 26, 2012

Study Start

October 1, 2011

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

January 30, 2012

Record last verified: 2012-01

Locations

EG(1)