Role of Serum Total Antioxidant Level in Preterm Labor

NCT ID: NCT01518816

Last Updated: 2012-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Labor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

control group

Group B: 35 pregnant women( controls )with uncomplicated pregnancies at a similar gestational ages followed routinely in the antenatal care unit.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Abdallah Salah Abdelatif

THE ROLE OF SERUM TOTAL ANTI OXIDANT IN PRETERM LABOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ABDALLAH s ABDELATIF, residant

Role: PRINCIPAL_INVESTIGATOR

Ain Shams Maternity Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams Maternity Hospital

Cairo, Tertiary, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohamed SE elsafty, lecturer

Role: CONTACT

01003922211 ext. 002

Ahmed M Ibrahim, ass proff

Role: CONTACT

01223416828 ext. 002

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Abdallah s Abdelatif, residant

Role: primary

01149013302 ext. 002

Mohamed SE Elsafty, lecturer

Role: backup

01003922211 ext. 002

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ABDO-0100

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Antioxidant Supplementation in Pregnant Women
NCT01232205 COMPLETED PHASE2/PHASE3