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Role of Serum Total Antioxidant Level in Preterm Labor

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Abdallah Salah Abdelatif, Ain Shams Maternity Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01518816
First Posted: January 26, 2012
Last Update Posted: January 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abdallah Salah Abdelatif, Ain Shams Maternity Hospital
  Purpose
The aim of this study is to detect the association between maternal serum antioxidant level and preterm labor.

Condition
Preterm Labor

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: the Role of Serum Total Antioxidant Level in Preterm Labor

Resource links provided by NLM:

MedlinePlus related topics: Antioxidants
U.S. FDA Resources

Further study details as provided by Abdallah Salah Abdelatif, Ain Shams Maternity Hospital:

Biospecimen Retention:   None Retained
serum

Estimated Enrollment: 70
Study Start Date: October 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01518816


Contacts
Contact: Mohamed SE elsafty, lecturer 01003922211 ext 002
Contact: Ahmed M Ibrahim, ass proff 01223416828 ext 002 abugooda@hotmail.com

Locations
Egypt
Ain Shams Maternity Hospital Recruiting
Cairo, Tertiary, Egypt
Contact: Abdallah s Abdelatif, residant    01149013302 ext 002    dr.abdallah_salah@yahoo.com   
Contact: Mohamed SE Elsafty, lecturer    01003922211 ext 002      
Principal Investigator: Abdallah S Abdelatif, residant         
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
Principal Investigator: ABDALLAH s ABDELATIF, residant Ain Shams Maternity Hospital
  More Information

Responsible Party: Abdallah Salah Abdelatif, THE ROLE OF SERUM TOTAL ANTI OXIDANT IN PRETERM LABOR, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT01518816     History of Changes
Other Study ID Numbers: ABDO-0100
First Submitted: January 24, 2012
First Posted: January 26, 2012
Last Update Posted: January 30, 2012
Last Verified: January 2012

Keywords provided by Abdallah Salah Abdelatif, Ain Shams Maternity Hospital:
antioxidant preterm labor

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs