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

Unknown

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

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

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

May 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 3, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Estimate)

April 4, 2014

Last Update Submitted That Met QC Criteria

April 3, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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