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Role of Serum Total Antioxidant Level in Preterm Labor

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ClinicalTrials.gov Identifier: NCT01518816
Recruitment Status : Unknown
Verified January 2012 by Abdallah Salah Abdelatif, Ain Shams Maternity Hospital.
Recruitment status was:  Recruiting
First Posted : January 26, 2012
Last Update Posted : January 30, 2012
Sponsor:
Information provided by (Responsible Party):
Abdallah Salah Abdelatif, Ain Shams Maternity Hospital

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

Condition or disease
Preterm Labor

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
Estimated Enrollment : 70 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: the Role of Serum Total Antioxidant Level in Preterm Labor
Study Start Date : October 2011
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

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.



Biospecimen Retention:   None Retained
serum


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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

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

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 Posted: January 26, 2012    Key Record Dates
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