Role of Serum Total Antioxidant Level in Preterm Labor

January 26, 2012 updated by: Abdallah Salah Abdelatif, Ain Shams Maternity Hospital

the Role of Serum Total Antioxidant Level in Preterm Labor

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

Study Overview

Status

Unknown

Conditions

Detailed Description

Study design:

This is a prospective case-control study.

Setting:

The study will be conducted at Ain Shams University Maternity Hospital.

Population of the study:

A total of 70 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.

Patient will be divided in to two groups. 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.

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

Every case will be subjected to:-

  1. Written informed consent before the study.
  2. Complete history .
  3. Complete general and abdominal examination.
  4. Infection markers(CRP,WBCs count, urine analysis ).
  5. Gestational age determination by the last menstrual date or Ultrasonography.
  6. Local pelvic examination.

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mohamed SE Elsafty, lecturer
  • Phone Number: 002 01003922211

Study Contact Backup

Study Locations

  • Egypt
    • Tertiary
      • Cairo, Tertiary, Egypt
        • Recruiting
        • Ain Shams Maternity Hospital
        • Contact:
          • Mohamed SE Elsafty, lecturer
          • Phone Number: 002 01003922211
        • Contact:
        • Principal Investigator:
          • Abdallah S Abdelatif, residant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Principal Investigator: ABDALLAH s ABDELATIF, residant, Ain Shams Maternity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

January 24, 2012

First Submitted That Met QC Criteria

January 25, 2012

First Posted (Estimate)

January 26, 2012

Study Record Updates

Last Update Posted (Estimate)

January 30, 2012

Last Update Submitted That Met QC Criteria

January 26, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABDO-0100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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