Role of Serum Total Antioxidant Level in Preterm Labor

Preterm Labor Clinical Trial

Official title:

the Role of Serum Total Antioxidant Level in Preterm Labor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01518816
• Other study ID #: ABDO-0100
• Status: Recruiting
• Phase: N/A
• First received: January 24, 2012
• Last updated: January 26, 2012
• Start date: October 2011
• Est. completion date: May 2012

Study information

• Verified date: January 2012
• Source: Ain Shams Maternity Hospital
• Contact: Mohamed SE elsafty, lecturer
• Phone: 01003922211
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity Hospital	Cairo	Tertiary

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt,