Preterm LaborNCT01518816
Role of Serum Total Antioxidant Level in Preterm Labor
An observational study of Preterm Labor, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
The aim of this study is to detect the association between maternal serum antioxidant level and preterm labor. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2011to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Preterm labor(pregnant between 28th and 37th week).
- Singleton pregnancy.
- Amnion membranes were intact
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mohamed SE elsafty, lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams Maternity Hospital
Cairo, Tertiary
Abdallah s Abdelatif, residant, 01149013302 ext. 002, dr.abdallah_salah@yahoo.com
Mohamed SE Elsafty, lecturer, 01003922211 ext. 002
About this study
Official title: the Role of Serum Total Antioxidant Level in Preterm Labor
The aim of this study is to detect the association between maternal serum antioxidant level and preterm labor.
Read the 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.
- Conditions
- Preterm Labor
- Keywords
- antioxidant preterm labor
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionApr 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Salah Abdelatif, Ain Shams Maternity Hospital
- Investigators
- ABDALLAH s ABDELATIF, residant, Principal investigator, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518816
- Sponsor's protocol ID
- ABDO-0100
- Status last verified
- Jan 2012
- First submitted
- 24 Jan 2012
- Last updated
- 30 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Role of Serum Total Antioxidant Level in Preterm Labor
- ClinicalTrials.gov ID
- NCT01518816
- Acronym / sponsor ID
- ABDO-0100
- Conditions
- Preterm Labor
- Keywords
- antioxidant preterm labor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 26 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to detect the association between maternal serum antioxidant level and preterm labor.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Preterm labor(pregnant between 28th and 37th week).
- Singleton pregnancy.
- Amnion membranes were intact
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed SE elsafty, lecturer contact
ABDALLAH s ABDELATIF, residant principal investigator
Ain Shams Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed SE elsafty, lecturer (01003922211 ext. 002), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2012.