Role of Serum Total Antioxidant Level in Preterm Labor

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   None Retained

serum

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 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