Role of Serum Total Antioxidant Level in Preterm Labor

• Conditions: Preterm Labor

• Registration Number: NCT01518816
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

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

• Study Start: 2011-10
• Status Verified: 2012-01
• Study First Submitted: 2012-01-24
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Last Update Submitted: 2012-01-26
• Last Update Posted: 2012-01-30
• Primary Completion: 2012-04
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Ain Shams Maternity Hospital; 🇪🇬 Cairo, Tertiary, Egypt