Role of Serum Total Antioxidant Level in Preterm Labor
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Ain Shams Maternity Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Ain Shams Maternity Hospital
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
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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:
Further study details as provided by Ain Shams Maternity Hospital:
Biospecimen Retention: None Retained
Detailed Description:
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:-
- Written informed consent before the study.
- Complete history .
- Complete general and abdominal examination.
- Infection markers(CRP,WBCs count, urine analysis ).
- Gestational age determination by the last menstrual date or Ultrasonography.
- Local pelvic examination.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518816
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
| 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:
|
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |
Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 30, 2016