Evaluation of the Role of Plasma Procalcitonin in Prediction of Intra-amniotic Infection in Preterm Premature Rupture of Membrane

April 3, 2014 updated by: Alaa Sayed Hassanin, Ain Shams Maternity Hospital

Procalcitonin Has a Role to Play in Prediction of Intra-amniotic Subclinical Infection.

It is hypothesized that the procalcitonin has a role to play in prediction of intra-amniotic subclinical infection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study population

  • This study will be conducted at the department of Obstetrics and Gynecology recruiting pregnant women selected from the attendees of antenatal clinic, emergency department and from inpatient wards of Ain Shams University Maternity Hospital from Mars2014.
  • This study will include 100 pregnant women these cases will be divided into 2 groups:
  • Group 1: Healthy preterm Group: will include 50 pregnant females all at 24-34 weeks of gestational age .
  • Group 2: Preterm premature rupture of membrane Group: will include 50 pregnant females all at 24-34 weeks of gestational age

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • Ain Shams Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Study population

  • This study will be conducted at the department of Obstetrics and Gynecology recruiting pregnant women selected from the attendees of antenatal clinic, emergency department and from inpatient wards of Ain Shams University Maternity Hospital from Mars2014.
  • This study will include 100 pregnant women these cases will be divided into 2 groups:
  • Group 1: Healthy preterm Group: will include 50 pregnant females all at 24-34 weeks of gestational age .
  • Group 2: Preterm premature rupture of membrane Group: will include 50 pregnant females all at 24-34 weeks of gestational age.

Description

Patients are with singleton pregnancies. Rupture of membranes will be diagnosed by history, sterile speculum examination to confirm fluid leakage from the cervical canal and ultrasound to confirm oligohydraminos.

Subclinical infection will be detected with laboratory indices (WBC count of ≥15, 000 c/mm3, CRP of ≥1 mg/dL) without any clinical symptoms and signs of infection as urinary tract infection in group 1 patients.

Women with multiple pregnancies. Clinical signs of infection as (fever,abdominal tendernes). Cervical dilatations of 2 cm or more. Maternal disease like diabetes or fetal complications like intra-uterine fetal death.

Inclusion Criteria:

-

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
procalcitonin in blood
-Group 1: Healthy preterm Group: will include 50 pregnant females all at 24-34 weeks of gestational age .
Drug: procalcitonin
In patient with preterm premature rupture of membrane (PPROM) is the procalcitonin can be used to predict intra-amniotic subclinical infection?
Other Names:
  • plasma
plasma of blood
-Group 2: Preterm premature rupture of membrane Group include 50 pregnant women
Drug: procalcitonin
In patient with preterm premature rupture of membrane (PPROM) is the procalcitonin can be used to predict intra-amniotic subclinical infection?
Other Names:
  • plasma
procalcitonin,prematureruptureofmembrane in blood

Complete history including (special habits like smoking and alcohol taking, menstrual history especially LMP, medical diseases, past obstetric history including duration, mode of delivery for each pregnancy, and if there were fetal or maternal complications).

Physical examination including (general condition, height, weight, vital signs).-Ultrasound to execlude multiple pregnancies, IUFD and to confirm oligohydraminos in group2.

The venous blood samples will be taken for measuring of -Procalcitonin in mothors -CRP and WBCs in mothers to detect infection -CRP in neonates of mothers of group 2.

They will be asked for their permission and consent.
Drug: procalcitonin
In patient with preterm premature rupture of membrane (PPROM) is the procalcitonin can be used to predict intra-amniotic subclinical infection?
Other Names:
  • plasma

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The correlation between procalcitonin level in PPROM and C-reactive protein level in neonates.
Time Frame: one year
The correlation between procalcitonin level in PPROM and C-reactive protein level in neonates
one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procalcitonin. - C-reactive protein. - White blood cells count (total and diffrantiated). -C-reactive protein in neonates of groub 2.
Time Frame: one year

Procalcitonin.

  • C-reactive protein.
  • White blood cells count (total and diffrantiated).
  • C-reactive protein in neonates of groub 2.
one year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procalcitonin. - C-reactive protein. - White blood cells count (total and diffrantiated). -C-reactive protein in neonates of groub 2.
Time Frame: one year

Procalcitonin.

  • C-reactive protein.
  • White blood cells count (total and diffrantiated).
  • C-reactive protein in neonates of groub 2.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams Maternity Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MRCOG-1988

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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