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

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

Detailed Description
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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

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

Conditions
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Intra-amniotic Subclinical Infection.

Intervention / Treatment
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* Drug: procalcitonin


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| procalcitonin in blood<br>-Group 1: Healthy preterm Group: will include 50 pregnant females all at 24-34 weeks of gestational age . | Drug: procalcitonin<br>* In patient with preterm premature rupture of membrane (PPROM) is the procalcitonin can be used to predict intra-amniotic subclinical infection?<br>* Other names: plasma;|
| plasma of blood<br>-Group 2: Preterm premature rupture of membrane Group include 50 pregnant women | Drug: procalcitonin<br>* In patient with preterm premature rupture of membrane (PPROM) is the procalcitonin can be used to predict intra-amniotic subclinical infection?<br>* Other names: plasma;|
| procalcitonin,prematureruptureofmembrane in blood<br>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<br>* In patient with preterm premature rupture of membrane (PPROM) is the procalcitonin can be used to predict intra-amniotic subclinical infection?<br>* Other names: plasma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between procalcitonin level in PPROM and C-reactive protein level in neonates. | 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. | Procalcitonin. C-reactive protein. White blood cells count (total and diffrantiated). C-reactive protein in neonates of groub 2. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Procalcitonin, intra-amniotic subclinical infection.