Text Size

Role of Serum Total Antioxidant Level in Preterm Labor

This study is currently recruiting participants.
Verified January 2012 by Ain Shams Maternity Hospital
Sponsor:
Information provided by (Responsible Party):
Abdallah Salah Abdelatif, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier:
NCT01518816
First received: January 24, 2012
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition
Preterm Labor

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: the Role of Serum Total Antioxidant Level in Preterm Labor

Resource links provided by NLM:

MedlinePlus related topics: Antioxidants
U.S. FDA Resources

Further study details as provided by Ain Shams Maternity Hospital:

Biospecimen Retention:   None Retained

serum


Estimated Enrollment: 70
Study Start Date: October 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: January 24, 2012
Last Updated: January 26, 2012
Health Authority: Egypt: Institutional Review Board

Keywords provided by Ain Shams Maternity Hospital:
antioxidant preterm labor

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013