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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01518816
Other study ID # ABDO-0100
Secondary ID
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


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, 

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